Effect of menstrual cycle and menopause on human gastric electrophysiology.

Chronic gastroduodenal symptoms disproportionately affect females of childbearing age; however, the effect of menstrual cycling on gastric electrophysiology is poorly defined. To establish the effect of the menstrual cycle on gastric electrophysiology, healthy subjects underwent noninvasive Body Surface Gastric Mapping (BSGM; 8x8 array) with the validated symptom logging App (Gastric Alimetry, New Zealand). Participants included were premenopausal females in follicular (n = 26) and luteal phases (n = 18) and postmenopausal females (n = 30) and males (n = 51) were controls. Principal gastric frequency (PGF), body mass index (BMI) adjusted amplitude, Gastric Alimetry Rhythm Index (GA-RI), Fed:Fasted Amplitude Ratio (ff-AR), meal response curves, and symptom burden were analyzed. Menstrual cycle-related electrophysiological changes were then transferred to an established anatomically accurate computational gastric fluid dynamics model (meal viscosity 0.1 Pas) to predict the impact on gastric mixing and emptying. PGF was significantly higher in the luteal versus follicular phase [mean 3.21 cpm, SD (0.17) vs. 2.94 cpm, SD (0.17), P < 0.001] and versus males [3.01 cpm, SD (0.2), P < 0.001]. In the computational model, this translated to 8.1% higher gastric mixing strength and 5.3% faster gastric emptying for luteal versus follicular phases. Postmenopausal females also exhibited higher PGF than females in the follicular phase [3.10 cpm, SD (0.24) vs. 2.94 cpm, SD (0.17), P = 0.01], and higher BMI-adjusted amplitude [40.7 µV (33.02-52.58) vs. 29.6 µV (26.15-39.65), P < 0.001], GA-RI [0.60 (0.48-0.73) vs. 0.43 (0.30-0.60), P = 0.005], and ff-AR [2.51 (1.79-3.47) vs. 1.48 (1.21-2.17), P = 0.001] than males. There were no differences in symptoms. These results define variations in gastric electrophysiology with regard to human menstrual cycling and menopause.NEW & NOTEWORTHY This study evaluates gastric electrophysiology in relation to the menstrual cycle using a novel noninvasive high-resolution methodology, revealing substantial variations in gastric activity with menstrual cycling and menopause. Gastric slow-wave frequency is significantly higher in the luteal versus follicular menstrual phase. Computational modeling predicts that this difference translates to higher rates of gastric mixing and liquid emptying in the luteal phase, which is consistent with previous experimental data evaluating menstrual cycling effects on gastric emptying.

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

INTRODUCTION: Birth at early term (37+0-38+6 completed gestational weeks [GW] and additional days) is associated with adverse neonatal outcomes compared with waiting to ≥39 GW. Most studies report outcomes after elective cesarean section or a mix of all modes of births; it is unclear whether these adverse outcomes apply to early-term babies born after induction of labor (IOL). We aimed to determine, in women with a non-urgent induction indication (elective/planned >48 h in advance), if IOL at early and late term was associated with adverse neonatal and maternal outcomes compared with IOL at full term. MATERIAL AND METHODS: An observational cohort study as a secondary analysis of a multicenter randomized controlled trial of 1087 New Zealand women with a planned IOL ≥37+0 GW. Multivariable logistic regression was used to analyze neonatal and maternal outcomes in relation to gestational age; 37+0-38+6 (early term), 39+0-40+6 (full term) and ≥41+0 (late term) GW. Neonatal outcome analyses were adjusted for sex, birthweight, mode of birth and induction indication, and maternal outcome analyses for parity, age, body mass index and induction method. The primary neonatal outcome was admission to neonatal intensive care unit (NICU) for >4 hours; the primary maternal outcome was cesarean section. RESULTS: Among the 1087 participants, 266 had IOL at early term, 480 at full term, and 341 at late term. Babies born following IOL at early term had increased odds for NICU admission for >4 hours (adjusted odds ratio [aOR] 2.16, 95% confidence intervals (CI) 1.16-4.05), compared with full term. Women having IOL at early term had no difference in emergency cesarean rates but had an increased need for a second induction method (aOR 1.70, 95% CI 1.15-2.51) and spent 4 h longer from start of IOL to birth (Hodges-Lehmann estimator 4.10, 95% CI 1.33-6.95) compared with those with IOL at full term. CONCLUSIONS: IOL for a non-urgent indication at early term was associated with adverse neonatal and maternal outcomes and no benefits compared with IOL at full term. These findings support international guidelines to avoid IOL before 39 GW unless there is an evidence-based indication for earlier planned birth and will help inform women and clinicians in their decision-making about timing of IOL.

Barriers and enablers to implementing an induction of labour guideline: A clinician survey.

BACKGROUND: Clinical guidelines improve outcomes, but poor compliance with recommendations is common. Insight into perceived barriers and enablers to the implementation of guidelines can engage maternity care providers and inform strategies for effective implementation. AIM: To identify the perceived barriers and enablers to implementing the 2020 'Induction of Labour [IOL] in Aotearoa New Zealand; a Clinical Practice Guideline.' MATERIALS AND METHODS: Electronic anonymous survey of clinical leaders in midwifery, obstetrics, and neonatology in New Zealand, from August to November 2021. Recruitment of participants was initially through provided lists of national clinical leads, followed by chain sampling. RESULTS: There were 32 of 89 surveys returned (36%). The most frequently identified enablers were implementation tools such as 'standardised IOL request form' and 'peer review process,' and administrative support and dedicated time. Six maternity hospitals already had peer review in place, whereby IOL requests that did not adhere to guidelines were reviewed by a multidisciplinary group of senior colleagues or peers, with individual feedback to the referring clinician. Attitudes in the form of 'existing systems, routines and culture' was the most frequently identified barrier, followed by external barriers such as 'lack of human resources.' CONCLUSIONS: Overall, few barriers were identified to implementing this guideline, and some of the key enablers were already in place. The identified enablers warrant future research to develop and evaluate effectiveness in improving outcomes.

Outpatient balloon catheter vs inpatient prostaglandin for induction of labor: a randomized trial.

BACKGROUND: Approximately 1 in 4 pregnant women undergo induction of labor. Meta-analyses have shown that mechanical methods of induction of labor are safe and effective, as is starting induction in an outpatient setting. However, few studies have evaluated outpatient balloon catheter induction in comparison with pharmacologic methods. OBJECTIVE: This study aimed to determine whether women who underwent outpatient induction of labor with a balloon catheter would have a lower cesarean delivery rate than women who underwent inpatient induction of labor with vaginal prostaglandin E2 without an increase in adverse maternal or neonatal events. STUDY DESIGN: This was a superiority randomized controlled trial. The eligibility criteria were pregnant women (nullipara and multipara) with a live singleton fetus in vertex presentation with any medical comorbidity who underwent planned induction of labor at term and who had an initial modified Bishop Score of 0 to 6 at 1 of 11 public maternity hospitals in New Zealand. The intervention groups were outpatient single balloon catheter induction in comparison with inpatient vaginal prostaglandin E2 induction. The primary hypothesis was that participants who started their induction at home with a balloon catheter would have a lower risk for cesarean delivery than participants who started their induction with prostaglandins and remained in hospital throughout. The primary outcome was cesarean delivery rate. Participants were randomized using a centralized secure online randomization website in a 1:1 ratio, stratified by parity and hospital. The participants and outcome assessors were not blinded to group allocation. An intention-to-treat analysis with adjustment for stratification variables was used. RESULTS: A total of 539 participants were randomized to outpatient balloon catheter induction, and 548 participants were randomized to inpatient prostaglandin induction; the mode of birth was reported for all participants. The cesarean delivery rate was 41.0% among participants allocated to outpatient balloon induction and 35.2% among those allocated to inpatient prostaglandin induction (adjusted odds ratio, 1.27; 95% confidence interval, 0.98-1.65). Women in the outpatient balloon catheter group were more likely to have artificial rupture of membranes and to received oxytocin and an epidural. No differences were found in the rates of adverse maternal or neonatal events. CONCLUSION: Outpatient balloon catheter induction was not found to reduce the cesarean delivery rate when compared with inpatient vaginal prostaglandin E2 induction. The use of balloon catheters in an outpatient setting does not seem to increase the rate of adverse events for mothers or babies and can be offered routinely.

Audit of waiting time-to-treatment of atypical endometrial hyperplasia.

BACKGROUND: Atypical endometrial hyperplasia (AEH) is the precursor lesion in endometrial carcinoma, the most common gynaecological malignancy in New Zealand, with inequities in disease burden and outcome for Maori and Pacific women. AIMS: In women diagnosed with AEH at two hospitals, to audit five standards of care for surgical management and time-to-treatment, and identify variation in care by ethnicity and other factors. MATERIALS AND METHODS: Demographic, referral, diagnostic and treatment characteristics were collected for women with a new AEH diagnosis between 1/1/2019 and 31/12/2020. Surgical management and time-to-treatment were audited against Royal College of Obstetricians and Gynaecologists and New Zealand Ministry of Health Faster Cancer Treatment recommendations. RESULTS: Of 124 participants, 60% were Pacific, 86% premenopausal, and 80% had obesity. For 55 women managed surgically, surgical standards of care were met. There were delays between referral, diagnosis and treatment - only 18% and 56% of women met the 62-day (referral to treatment) and 31-day (decision-to-treat to treatment) targets, respectively. Wait times were prolonged for women who had dilation and curettage (vs pipelle), magnetic resonance imaging (MRI) (vs no MRI), and surgery (vs medical management). Ethnic disparities were not identified for any standard. DISCUSSION: Delays to treatment were found throughout women's journeys. Hospital services can streamline their clinical pathways for women referred for abnormal uterine bleeding, flagging obesity as a high suspicion for cancer indicator, increasing access to endometrial sampling in primary care and establishing 'one-stop-shop' outpatient assessment with empiric initiation of intrauterine progestogen.

Screening of diabetes in pregnancy in New Zealand: translation of national guidelines into practice.

AIM: To evaluate the proportion of pregnant women who completed screening for pre-existing diabetes and GDM, following publication of the Guideline. METHODS: A stocktake was conducted of clinical audits by University of Auckland medical students in nine New Zealand public hospitals between 2015 and 2021. Audits were included if they investigated whether women who gave birth were screened for diabetes in pregnancy according to Guideline recommendations. RESULTS: Nineteen audits of 3213 women investigated the screening rates for (1) pre-existing diabetes, by 20 weeks' gestation, using HbA1c [n=16]); (2) oral glucose tolerance test, OGTT, follow up of abnormal HbA1c at 24-28 weeks' [n=4]); (3) glucose challenge test, GCT, at 24-28 weeks' [n=9]); and (4) OGTT follow-up of abnormal GCT [n=10]). There was improvement in HbA1c screening, from 28% in 2015 to 84% in 2020. OGTT testing rates were high in all audits. Maori had lower rates of screening for GDM (standards 2 & 3) than non-Maori (62% versus 86%, p<0.05; 3 audits, n=837). CONCLUSIONS: The national guideline made a positive contribution to the quality of care provided, however, further targeted interventions need to be implemented to meet the standard of care, especially for Maori women.

Interventions for heavy menstrual bleeding; overview of Cochrane reviews and network meta-analysis.

BACKGROUND: Heavy menstrual bleeding (HMB) is excessive menstrual blood loss that interferes with women's quality of life, regardless of the absolute amount of bleeding. It is a very common condition in women of reproductive age, affecting 2 to 5 of every 10 women. Diverse treatments, either medical (hormonal or non-hormonal) or surgical, are currently available for HMB, with different effectiveness, acceptability, costs and side effects. The best treatment will depend on the woman's age, her intention to become pregnant, the presence of other symptoms, and her personal views and preferences. OBJECTIVES: To identify, systematically assess and summarise all evidence from studies included in Cochrane Reviews on treatment for heavy menstrual bleeding (HMB), using reviews with comparable participants and outcomes; and to present a ranking of the first- and second-line treatments for HMB. METHODS: We searched for published Cochrane Reviews of HMB interventions in the Cochrane Database of Systematic Reviews. The primary outcomes were menstrual bleeding and satisfaction. Secondary outcomes included quality of life, adverse events and the requirement of further treatment. Two review authors independently selected the systematic reviews, extracted data and assessed quality, resolving disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool and evaluated the certainty of the evidence for each outcome using GRADE methods. We grouped the interventions into first- and second-line treatments, considering participant characteristics (desire for future pregnancy, failure of previous treatment, candidacy for surgery). First-line treatments included medical interventions, and second-line treatments included both the levonorgestrel-releasing intrauterine system (LNG-IUS) and surgical treatments; thus the LNG-IUS is included in both groups. We developed different networks for first- and second-line treatments. We performed network meta-analyses of all outcomes, except for quality of life, where we performed pairwise meta-analyses. We reported the mean rank, the network estimates for mean difference (MD) or odds ratio (OR), with 95% confidence intervals (CIs), and the certainty of evidence (moderate, low or very low certainty). We also analysed different endometrial ablation and resection techniques separately from the main network: transcervical endometrial resection (TCRE) with or without rollerball, other resectoscopic endometrial ablation (REA), microwave non-resectoscopic endometrial ablation (NREA), hydrothermal ablation NREA, bipolar NREA, balloon NREA and other NREA. MAIN RESULTS: We included nine systematic reviews published in the Cochrane Library up to July 2021. We updated the reviews that were over two years old. In July 2020, we started the overview with no new reviews about the topic. The included medical interventions were: non-steroidal anti-inflammatory drugs (NSAIDs), antifibrinolytics (tranexamic acid), combined oral contraceptives (COC), combined vaginal ring (CVR), long-cycle and luteal oral progestogens, LNG-IUS, ethamsylate and danazol (included to provide indirect evidence), which were compared to placebo. Surgical interventions were: open (abdominal), minimally invasive (vaginal or laparoscopic) and unspecified (or surgeon's choice of route of) hysterectomy, REA, NREA, unspecified endometrial ablation (EA) and LNG-IUS. We grouped the interventions as follows. First-line treatments Evidence from 26 studies with 1770 participants suggests that LNG-IUS results in a large reduction of menstrual blood loss (MBL; mean rank 2.4, MD -105.71 mL/cycle, 95% CI -201.10 to -10.33; low certainty evidence); antifibrinolytics probably reduce MBL (mean rank 3.7, MD -80.32 mL/cycle, 95% CI -127.67 to -32.98; moderate certainty evidence); long-cycle progestogen reduces MBL (mean rank 4.1, MD -76.93 mL/cycle, 95% CI -153.82 to -0.05; low certainty evidence), and NSAIDs slightly reduce MBL (mean rank 6.4, MD -40.67 mL/cycle, -84.61 to 3.27; low certainty evidence; reference comparator mean rank 8.9). We are uncertain of the true effect of the remaining interventions and the sensitivity analysis for reduction of MBL, as the evidence was rated as very low certainty. We are uncertain of the true effect of any intervention (very low certainty evidence) on the perception of improvement and satisfaction. Second-line treatments Bleeding reduction is related to the type of hysterectomy (total or supracervical/subtotal), not the route, so we combined all routes of hysterectomy for bleeding outcomes. We assessed the reduction of MBL without imputed data (11 trials, 1790 participants) and with imputed data (15 trials, 2241 participants). Evidence without imputed data suggests that hysterectomy (mean rank 1.2, OR 25.71, 95% CI 1.50 to 439.96; low certainty evidence) and REA (mean rank 2.8, OR 2.70, 95% CI 1.29 to 5.66; low certainty evidence) result in a large reduction of MBL, and NREA probably results in a large reduction of MBL (mean rank 2.0, OR 3.32, 95% CI 1.53 to 7.23; moderate certainty evidence). Evidence with imputed data suggests hysterectomy results in a large reduction of MBL (mean rank 1.0, OR 14.31, 95% CI 2.99 to 68.56; low certainty evidence), and NREA probably results in a large reduction of MBL (mean rank 2.2, OR 2.87, 95% CI 1.29 to 6.05; moderate certainty evidence). We are uncertain of the true effect for REA (very low certainty evidence). We are uncertain of the effect on amenorrhoea (very low certainty evidence). Evidence from 27 trials with 4284 participants suggests that minimally invasive hysterectomy results in a large increase in satisfaction (mean rank 1.3, OR 7.96, 95% CI 3.33 to 19.03; low certainty evidence), and NREA also increases satisfaction (mean rank 3.6, OR 1.59, 95% CI 1.09 to 2.33; low certainty evidence), but we are uncertain of the true effect of the remaining interventions (very low certainty evidence). AUTHORS' CONCLUSIONS: Evidence suggests LNG-IUS is the best first-line treatment for reducing menstrual blood loss (MBL); antifibrinolytics are probably the second best, and long-cycle progestogens are likely the third best. We cannot make conclusions about the effect of first-line treatments on perception of improvement and satisfaction, as evidence was rated as very low certainty. For second-line treatments, evidence suggests hysterectomy is the best treatment for reducing bleeding, followed by REA and NREA. We are uncertain of the effect on amenorrhoea, as evidence was rated as very low certainty. Minimally invasive hysterectomy may result in a large increase in satisfaction, and NREA also increases satisfaction, but we are uncertain of the true effect of the remaining second-line interventions, as evidence was rated as very low certainty.

Levonorgestrel-releasing intrauterine device (LNG-IUD) for symptomatic endometriosis following surgery.

BACKGROUND: Endometriosis is a condition characterised by the presence of ectopic deposits of endometrial-like tissue outside the uterus, usually in the pelvis. The impact of laparoscopic treatment on overall pain is uncertain and a significant proportion of women will require further surgery. Therefore, adjuvant medical therapies following surgery, such as the levonorgestrel-releasing intrauterine device (LNG-IUD), have been considered to reduce recurrence of symptoms.  OBJECTIVES: To determine the effectiveness and safety of post-operative LNG-IUD in women with symptomatic endometriosis. SEARCH METHODS: We searched the following databases from inception to January 2021: The Specialised Register of the Cochrane Gynaecology and Fertility Group, CENTRAL (which now includes records from two trial registries), MEDLINE, Embase, PsycINFO, LILACS and Epistemonikos. We handsearched citation lists of relevant publications, review articles, abstracts of scientific meetings and included studies. We contacted experts in the field for information about any additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing women undergoing surgical treatment of endometriosis with uterine preservation who were assigned to LNG-IUD insertion, versus control conditions including expectant management, post-operative insertion of placebo (inert intrauterine device), or other medical treatment such as gonadotrophin-releasing hormone agonist (GnRH-a) drugs. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, and extracted data to allow for an intention-to-treat analysis. For dichotomous data, we calculated the risk ratio (RR) and 95% confidence interval (CI) using the Mantel-Haenszel fixed-effect method. For continuous data, we calculated the mean difference (MD) and 95% CI using the inverse variance fixed-effect method. MAIN RESULTS: Four RCTs were included, with a total of 157 women. Two studies are ongoing. The GRADE certainty of evidence was very low to low. The certainty of evidence was graded down primarily for serious risk of bias and imprecision. LNG-IUD versus expectant management Overall pain: No studies reported on the primary outcome of overall pain. Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at 12 months. Data on this outcome were reported on by two RCTs; meta-analysis was not possible (RCT 1: delta of median visual analogue scale (VAS) 81 versus 50, P = 0.006, n = 55; RCT 2: fall in VAS by 50 (35 to 65) versus 30 (25 to 40), P = 0.021, n = 40; low-certainty evidence). Quality of life: We are uncertain whether LNG-IUD improves quality of life at 12 months. One trial demonstrated a change in total quality of life score with postoperative LNG-IUD from baseline (mean 61.2 (standard deviation (SD) 14.8) to 12 months (mean 70.3 (SD 16.2) compared to expectant management (baseline 55.1 (SD 17.0) to 57.0 (SD 33.2) at 12 months) (n = 55, P = 0.014, very low-certainty evidence). Patient satisfaction: Two studies found higher rates of satisfaction with LNG-IUD compared to expectant management; however, combining the studies in meta-analysis was not possible (n = 95, very low-certainty evidence). One study found 75% (15/20) of those given post-operative LNG-IUD were "satisfied" or "very satisfied", compared to 50% (10/20) of those in the expectant management group (RR 1.5, 95% CI 0.90-2.49, 1 RCT, n=40, very low-certainty evidence). The second study found that fewer were "very satisfied" in the expectant management group when compared to LNG, but there were no data to include in a meta-analysis.  Adverse events: One study found a significantly higher proportion of women reporting melasma (n = 55, P = 0.015, very low-certainty evidence) and bloating (n = 55, P = 0.021, very low-certainty evidence) following post-operative LNG-IUD. There were no differences in other reported adverse events, such as weight gain, acne, and headaches.  LNG-IUD versus GnRH-a Overall pain: No studies reported on the primary outcome of overall pain. Chronic pelvic pain: We are uncertain whether LNG-IUD improves chronic pelvic pain at 12 months when compared to GnRH-a (VAS pain scale) (MD -2.0, 95% CI -20.2 to 16.2, 1 RCT, n = 40, very low-certainty evidence). Dysmenorrhoea: We are uncertain whether LNG-IUD improves dysmenorrhoea at six months when compared to GnRH-a (measured as a reduction in VAS pain score) (MD 1.70, 95%.CI -0.14 to 3.54, 1 RCT, n = 18, very low-certainty evidence). Adverse events: One study suggested that vasomotor symptoms were the most common adverse events reported with patients receiving GnRH-a, and irregular bleeding in those receiving LNG-IUD (n = 40, very low-certainty evidence) AUTHORS' CONCLUSIONS: Post-operative LNG-IUD is widely used to reduce endometriosis-related pain and to improve operative outcomes. This review demonstrates that there is no high-quality evidence to support this practice. This review highlights the need for further studies with large sample sizes to assess the effectiveness of post-operative adjuvant hormonal IUD on the core endometriosis outcomes (overall pain, most troublesome symptom, and quality of life).

Perineal trauma management and follow-up: Are we meeting the standard of care?

BACKGROUND: Birth-related third- and fourth-degree perineal trauma is common and associated with short- and long-term complications. AIM: To conduct a review of clinical audits investigating management of women with perineal trauma. MATERIALS AND METHODS: We identified all audits undertaken in eight New Zealand public hospitals between 2005 and 2014 that investigated whether women with birth-related third- and fourth-degree perineal trauma were receiving care according to clinical guidelines. We aggregated audit results and calculated the proportion of women receiving the recommended standard of care. RESULTS: During the review period, 25 audits investigated intra-operative (n = 11), post-operative (n = 14) and outpatient care (n = 18). Baseline audits showed variation in care by site; intra-operative care (range 39-96% for repair conducted under anaesthesia, 60-96% for repair by or under supervision of a senior clinician, and 33-54% for completion of Accident Compensation Corporation forms); post-operative care (range 40-93% for prescribed antibiotics and 33-96% for stool softeners) and outpatient care (45-84% for referral to outpatient clinic and 54-78% for physiotherapy follow-up). Sustained high quality of care and improvements in adherence with recommendations were seen for most of the follow-up audits (eg 90% adherence for prescribed stool softeners over three audits; over 50% increase in prescribed antibiotics over seven years). CONCLUSIONS: These clinical audits exemplify the need to measure patient care against standards, learn from the findings, implement changes to improve patient experience and reduce life-long sequelae from perineal trauma. This review showed some progress in some care services and highlighted where further changes are needed to close evidence-practice gaps.

Levonorgestrel-releasing intrauterine system for endometrial hyperplasia.

BACKGROUND: In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens. OBJECTIVES: To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment. SEARCH METHODS: We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods. MAIN RESULTS: Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG-IUS versus non-intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia The LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence), Adverse effects associated with LNG-IUS There was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG-IUS versus no treatment Regression of endometrial hyperplasia One study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.

Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial.

BACKGROUND: Approximately one in four pregnant women undergo an induction of labour. The purpose of this study is to investigate the clinical effectiveness, safety, and cost-effectiveness for mothers and babies of two methods of cervical ripening - inpatient care for women starting induction with vaginal prostaglandin E2 hormones, or allowing women to go home for 18 to 24 h after starting induction with a single-balloon catheter. METHODS/DESIGN: This is a multi-centre randomised controlled trial in New Zealand. Eligible pregnant women, with a live singleton baby in a cephalic presentation who undergo a planned induction of labour at term, will be randomised to outpatient balloon-catheter induction or in-hospital prostaglandin induction. The primary outcome is caesarean section rate. To detect a 24% relative risk reduction in caesarean rate from a baseline of 24.8%, with 80% power and 5% type 1 error, will require 1552 participants in a one to one ratio. DISCUSSION: If outpatient balloon-catheter induction reduces caesarean section rates, has additional clinical benefits, and is safe, cost-effective, and acceptable to women and clinicians, we anticipate change in induction of labour practice around the world. We think that home-based balloon-catheter induction will be welcomed as part of a patient-centred labour-induction care package for pregnant women. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12616000739415. Registered on 6 June 2016.

The State of Quality Improvement Teaching in Medical Schools: A Systematic Review.

INTRODUCTION: While teaching patient safety and quality improvement (QI) skills to medical students is endorsed as being important, best practice for achieving learner outcomes in QI is particularly unclear. We systematically reviewed QI curricula for medical students to identify approaches to QI training that are associated with positive learner outcomes. METHODS: We searched databases (Medline, EMBASE, and Scopus) and article bibliographies for studies published from 2009 to 2018. Studies evaluating QI teaching for medical students in any setting and reporting learner outcomes were included. Educational content, teaching format, achievement of learning outcomes, and methodological features were abstracted. Outcomes assessed were learners' satisfaction, attitudes, knowledge and skills, changes in behavior and clinical processes, and benefits to patients. RESULTS: Twenty of 25 curricula targeted medical students exclusively. Most curricula were well accepted by students (11/13 studies), increased their confidence in QI (9/11) and led to knowledge acquisition (17/20). Overall, positive learner outcomes (Kirkpatrick Levels 1 to 4A) were demonstrated across a range of curricular content and teaching modalities. In particular, 2 curricula demonstrated positive changes in learners' behavior (Kirkpatrick Level 3), both incorporating a clinical audit or QI project based in hospitals, and supplemented by didactic lectures. Seven curricula were associated with improvements in processes of care (Kirkpatrick Level 4A) all of which were set in a clinical setting and supplemented by didactic lectures and/or small group sessions. None of the curricula evaluated patient benefits (Kirkpatrick Level 4B). CONCLUSIONS: Whilst there is heterogeneity in educational content and teaching methods, most curricula are well accepted and led to learners' knowledge acquisition. Although there is limited evidence for the impact of QI curricula on learner behavior and benefit to patients, and for interprofessional QI curricula, teaching QI in the clinical setting leads to better learner outcomes with location being potentially a surrogate for clinical experience.

Birth choices for women in a 'Positive Birth after Caesarean' clinic: Randomised trial of alternative shared decision support strategies.

BACKGROUND: Systematic approaches to information giving and decision support for women with previous caesarean sections are needed. AIM: To evaluate decision support within a 'real-world' shared decision-making model. METHODS: A pragmatic comparative effectiveness randomised trial in the Positive Birth After Caesarean Clinic. Women with one previous caesarean and singleton pregnancy <25 weeks were randomly allocated to standard Positive Birth After Caesarean care, or standard Positive Birth After Caesarean care plus a decision aid booklet. Main outcome measure was mode of birth, with secondary measures of knowledge, decisional conflict, birth choice, adherence to birth choice, perception of decision support, and satisfaction. RESULTS: Of 297 participants, rate of attempted vaginal birth after caesarean increased and was similar for both groups (61% vs 57%, P = 0.5). Knowledge scores increased more for women in the additional decision aid group (2.0 vs 1.6 points, P = 0.2). Decisional conflict score reduction was similar between groups (P = 0.5). Women initially unsure of their birth preference who received the additional decision aid had greater reduction in decisional conflict score (P = 0.04) and were more likely to plan vaginal birth after caesarean (49% vs 33%, P = 0.2). Adherence to birth choice and birth satisfaction was similar between groups. Women in the additional decision aid group rated their decision support tool higher (P < 0.01). CONCLUSIONS: In a 'real world' shared decision-making model, an additional decision aid conferred some benefits in factors associated with preparation for shared decision-making. Decision aids may provide particular benefit for women who are initially unsure and need assistance in the deliberation phase.

Neighborhood Income and Cesarean Section Rates at a Tertiary Care Center in Canada.

Background: With rising rates of cesarean sections (CSs) in Canada and worldwide, nonclinical factors for CS warrant consideration. Objective: To determine the association between a primigravid woman's neighborhood income and rates of CSs. Materials and Methods: A retrospective cohort study was conducted at an Ontario tertiary care center from January 2003 to December 2013. Rates of CSs were determined using data collected from the Discharge Abstract Database. Women with singleton live births were included. The main exposure variable was the neighborhood income quintile. A multivariable model was used to adjust for covariates and provide an estimate of the independent effect of neighborhood income on the CS rate. Results: The study cohort comprised 32,714 women. Compared with the lowest quintile, women in the highest quintile had increased rates of CSs (relative risk, RR 1.06, 95% confidence interval, CI [1.02-1.11]). Following adjustment for important confounders, there was no longer an association between the neighborhood income and CS rate (adjusted RR 1.00, 95% CI [0.99-1.01]). Women in the highest quintile were more likely to have greater maternal age (p < 0.01). Conclusions: Although differences in CS rates are seen by the neighborhood income quintile, they appear to be mediated through a combination of maternal age and other clinical factors. Neighborhood income does not appear to be an independent predictor of CS.

Combined hormonal contraceptives for heavy menstrual bleeding.

BACKGROUND: Menorrhagia or heavy menstrual bleeding (HMB) is an excessive blood loss that impairs a woman's quality of life, either physical, emotional, social or material. It is benign and not associated with pregnancy or any other gynaecological or systemic disease. Medical treatments used to reduce excessive menstrual blood loss (MBL) include prostaglandin synthetase inhibitors, antifibrinolytics, oral contraceptive pills, and other hormones. The combined oral contraceptive pill (COCP) is claimed to have a variety of beneficial effects, inducing a regular shedding of a thinner endometrium and inhibiting ovulation, thus having the effect of both treating HMB and providing contraception. More recently, a contraceptive vaginal ring (CVR) has been trialled to investigate whether this treatment can provide similar benefits to COCP while lessening hormonal systemic exposure. This review is an update of a review which originally focused on COCP alone. The scope of the review has been widened to consider other types of delivery of combined hormonal contraceptives for reduction of MBL. OBJECTIVES: To determine the efficacy of combined hormonal contraceptives (pills, vaginal ring or patch) compared with other medical therapies, placebo, or no therapy in the treatment of HMB. A secondary objective was to compare the COCP with the CVR. SEARCH METHODS: We searched the Gynecology and Fertility Group trials register, MEDLINE, Embase, CENTRAL, CINAHL and PsycINFO (search dates: Oct 1996, May 2002, June 2004, April 2006, June 2009, July 2017 and September 2018) for all randomised controlled trials (RCTs) of COCP and CVR for the treatment of HMB. We also searched trial registers and the reference lists of retrieved studies for additional trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of the use of COCP or CVR compared with no treatment, placebo, or other medical therapies for women with HMB and regular menstrual cycles. DATA COLLECTION AND ANALYSIS: All assessments of trial quality and data extraction were performed unblinded by at least two review authors. Our primary review outcomes were treatment success, menstrual bleeding (assessed objectively, semi-objectively or subjectively), and participant satisfaction with treatment. Secondary outcomes were adverse events, quality of life, and haemoglobin level. MAIN RESULTS: We identified eight RCTs involving 805 participants. Two trials comparing COCP with placebo were considered to be moderate quality and the remaining studies were low to very low quality, mainly because of serious risk of bias from lack of blinding and concerns over precision.COCP versus placeboCOCP, with a step-down oestrogen and step-up progestogen regimen, improved response to treatment (return to menstrual 'normality') (OR 22.12, 95% CI 4.40 to 111.12; 2 trials; 363 participants; I2 = 50%; moderate-quality evidence), and lowered MBL (OR 5.15, 95% CI 3.16 to 8.40; 2 trials; 339 participants; I2 = 0%; moderate-quality evidence) when compared to placebo. The results suggested that, if the chance of 'successful' treatment was 3% in women taking placebo, then COCP increased this chance from 12% to 77% in women with unacceptable HMB. Minor adverse events, in particular breast pain, were more common with COCP. No study in this comparison reported semi-objectively assessed MBL or participant satisfaction with treatment.COCP versus other medical treatmentsNon-steroidal anti-inflammatory drugs (NSAIDs)There was insufficient evidence to determine whether the COCP reduced MBL when compared to NSAIDs (mefenamic acid and naproxen). No study in this comparison reported semi-objectively assessed MBL, subjectively assessed MBL, participant satisfaction with treatment or adverse events.Levonorgestrel-releasing intrauterine system (LNG IUS)The LNG IUS was more effective than COCP in reducing MBL (OR 0.21, 95% CI 0.09 to 0.48; 2 trials; 151 participants; I2 = 0%; low-quality evidence) but it was not clear whether satisfaction with treatment or adverse effects varied according to which treatment was used. No study in this comparison reported semi-objectively assessed MBL or subjectively assessed MBL.Contraceptive vaginal ring (CVR) versus other medical treatmentsCOCP COCP was compared with CVR in two trials. There were discrepancies between some of the findings and there was no evidence of a benefit for one treatment compared to the other for response to treatment, MBL or participant satisfaction with treatment. There was a greater likelihood of nausea with COCP. No study in this comparison reported objectively assessed MBL or subjectively assessed MBL.ProgestogensCVR was compared to long course progestogens in one trial. It is possible that CVR increased the odds of satisfaction; but we are uncertain whether CVR improved MBL. The evidence was based on small numbers of participants and was very low quality, so definitive conclusions could not be reached. No study in this comparison reported objectively assessed MBL, subjectively assessed MBL, or adverse events. AUTHORS' CONCLUSIONS: Moderate-quality evidence suggests that the combined oral contraceptive pill over six months reduces HMB in women with unacceptable HMB from 12% to 77% (compared to 3% in women taking placebo). When compared with other medical options for HMB, COCP was less effective than the LNG IUS. Limited evidence suggested that COCP and CVR had similar effects. There was insufficient evidence to determine comparative efficacy of combined hormonal contraceptives with NSAIDs, or long course progestogens.

Body Mass Index is Negatively Associated with Endometrial Cancer Stage, Regardless of Subtype and Menopausal Status.

Objective: Obesity is one of the common risk factors for developing of endometrial cancer and is negatively associated with its survival, although this result is controversial. Endometrial cancer stages range from stage I, which has better clinical outcomes to stage IV, which has poorer clinical outcomes. Endometrial cancer traditionally divides into type 1 and type 2 dependent on histology which has different clinical outcomes. In this study we investigated whether obesity is associated with the stages of endometrial cancer taking into account subtypes of cancer and menopausal status. Methods: Data on 1,104 women with endometrial cancer were retrospectively collected from the largest women's hospital in China and analysed. Data included age at diagnosis, body mass index (BMI), histology of cancer and menopausal status. Results: The BMI in patients with stage I endometrial cancer was significantly higher than that in patients with stage II or III or IV (p=0.0001). However, there was no statistical difference in BMI between patients with stage II, and stage III endometrial cancer. This negative association was persisted with type 1 and type 2 endometrial cancer (p=0.1989) and premenopausal and post-menopausal status (p=0.4342). In addition, the proportion of over-weight or obese women in type1 endometrial cancer with stage I was not different to type 2 endometrial cancer with stage I. Conclusion: Our data demonstrate that BMI is negatively associated with endometrial cancer in early stage regardless of subtypes of cancer, menopausal status and obesity may be also a potential risk factor for developing type 2 endometrial cancer.

Risk of perinatal mortality in the first year of midwifery practice in New Zealand: analysis of a retrospective national cohort.

OBJECTIVES: To determine whether there was an increased risk of perinatal mortality among mothers booked for care with community lead maternity carer (LMC) midwives in their first compared with later years of practice. DESIGN: Retrospective cohort study using linked national maternity, mortality and workforce data; adjusted analysis using logistic regression. SETTING: New Zealand. PARTICIPANTS: Women under community LMC midwifery care birthing 2008-2014. MAIN OUTCOME MEASURES: Perinatal mortality (stillbirths and neonatal deaths of babies born from 20 weeks' gestation to the 27th day of postnatal life), excluding terminations and deaths associated with congenital abnormalities. RESULTS: There were 2045 deaths among 344 910 births booked with midwives.First year of practice midwives cared for women with higher risk of perinatal mortality, including Maori, Pacific, Indian, <20-year-old mothers, nullipara, smokers, women living in socioeconomic deprivation and with high body mass index, than midwives beyond first year of practice.There was a significant reduction in unadjusted odds of perinatal mortality among women under the care of midwives beyond the first year compared with those within the first year (OR 0.79, 95% CI 0.67 to 0.93) but no significant reduction in risk remained after adjusting for known risk factors, (OR 0.89, 95% CI 0.74 to 1.07).There was a significant increase in the adjusted odds of perinatal mortality among midwives booking a caseload of 15 or fewer mothers per year (1.34, 1.01 to 1.78) and 16 to 30 (1.25, 1.04 to 1.50) compared with midwives booking 51 to 80. CONCLUSIONS: Findings suggest that the first year of midwifery practice is not associated with an increased risk of perinatal mortality but there is evidence that early career midwives are caring for higher-risk women. These findings suggest inequity of access for higher-risk women to experienced midwives and highlight an opportunity to improve support for vulnerable women and new midwives.

Effect of excessive gestational weight gain on trial of labour after caesarean: A retrospective cohort study.

BACKGROUND: Counselling women for and managing birth after caesarean section are important. Research is needed on evaluation of antenatal factors that predict likelihood of successful trial of labour after caesarean section (TOLAC). AIM: To evaluate the effect of gestational weight gain on mode of delivery in women having TOLAC. MATERIALS AND METHODS: A retrospective cohort study of eligible women who underwent TOLAC (January 2012 to July 2015) at a large urban hospital. Gestational weight gain was classified as 'excessive' or 'not excessive' based on calculated pre-pregnancy body mass index. Multivariable logistic regression analysis was performed to estimate the association of gestational weight gain and vaginal birth, adjusting for socio-demographic and pregnancy-related factors. RESULTS: Of 534 women, those who gained excessive weight were less likely to have a vaginal birth as women who did not (adjusted odds ratio (aOR) 0.48, 95% confidence interval (CI) 0.29-0.81)). Women with previous vaginal birth were more likely to have a vaginal birth (aOR 3.74, 95% CI 1.90-7.36), while women ≥35, women who had an epidural, and women who delivered at 40 weeks, were less likely (aOR 0.58, 95% CI 0.35-0.97, aOR 0.12, 95% CI 0.07-0.22, and aOR 0.53, 95% CI 0.31-0.91, respectively). CONCLUSIONS: Gaining excessive weight in pregnancy is potentially modifiable, and can be incorporated into individual antenatal counselling, and into risk prediction models, to assist with informed decision making around planned mode of delivery in women with previous caesarean section. Future research could focus on interventions to reduce gestational weight gain in women planning TOLAC.

Social and Geographic Determinants of Hysterectomy in Ontario: A Population-Based Retrospective Cross-Sectional Analysis.

OBJECTIVES: This study sought to determine whether social factors (neighbourhood education and income) and geographic factors (urban or rural dwelling and local service area) are associated with hysterectomy rates, proportion of hysterectomies performed minimally invasively, and hysterectomy complication and readmission rates in Ontario. METHODS: The Canadian Institute for Health Information Discharge Abstract Database was used to perform a population-based retrospective cross-sectional study on women who had an abdominal, vaginal, and laparoscopic hysterectomy in 2007 for benign gynaecologic conditions in hospitals in Ontario, Canada. Crude and age-standardized rates of hysterectomy, proportion of hysterectomy performed minimally invasively (vaginal or laparoscopic), and rates of surgical complications were analyzed by neighbourhood educational attainment, neighbourhood income, rural or urban residency, and health service delivery area (Canadian Task Force Classification of Study Design II). RESULTS: A total of 13 511 women who underwent hysterectomy were included. Age-standardized hysterectomy rates were higher for the lowest neighbourhood educational quartile compared with the highest (relative risk [RR] 1.49; 95% CI 1.39-1.60), higher with rural compared with urban dwelling (RR 1.54; 95% CI 1.47-1.61), varied with local health service delivery area (Local Health Integration Network [LHIN]) (range 133.4-439.5 per 100 000 women), and also varied non-linearly with neighbourhood income quintile. Proportion of hysterectomies performed minimally invasively did not vary with neighbourhood education or income, were higher for rural compared with urban areas (RR 1.10; 95% CI 1.03-1.19), and varied with LHIN (range 30.0-62.9 per 100 hysterectomies). Surgical complications varied with neighbourhood educational quartile, but not with income or urban or rural residence. CONCLUSIONS: Considerable social and geographic variation exists in rates of hysterectomy in Ontario, whereas only geographic variation is seen in use of minimally invasive routes. Surgical complication rates vary only by neighbourhood education. Such findings suggest inequities in hysterectomy practice in Ontario, and there is a need to evaluate factors influencing patients' decision making, physicians' clinical and surgical practice, and health system policies to help address the observed disparities.

Is the delivery of a quality improvement education programme in obstetrics and gynaecology for final year medical students feasible and still effective in a shortened time frame?

BACKGROUND: Teaching clinical audit skills to nascent health professionals is one strategy to improve frontline care. The undergraduate medical curriculum at the University of Auckland provides improvement science theory and skills in Year 5 teaching, and the opportunity to put this into practice during an Obstetrics and Gynaecology (O&G) clinical attachment in Year 6. In 2015, a revised medical school curriculum at the university resulted in a planned reduction of the O&G attachment from five weeks to four, necessitating revision of the Year 6 Quality Improvement (QI) project. The aim of this study was to evaluate if the revised programme provided an important experiential learning opportunity for medical students without imposing an unsustainable burden on clinical services. METHODS: Based on a CIPP (Context/Input/Process/Product) evaluation model, the study was conducted in several stages to get a sense of the context as the new programme was being planned (Context evaluation), the feasibility of an alternative approach to meet the educational need (Input evaluation), the implementation of the revised programme (Process evaluation) and finally, the programme outcomes (Product evaluation). We used multiple data sources (supervisors, students, academic administrators, and hospital staff) and data collection methods (questionnaires, focus groups, individual interviews, consultative workshops, student reports and oral presentations). RESULTS: The context evaluation revealed the Year 6 QI programme to be valuable and contributed to O&G service improvements, however, the following concerns were identified: time to complete the project, timely topic selection and access to data, recognition of student achievement, and staff workload. The evaluation of the revised QI project indicated improvement in student perceptions of their QI knowledge and skills, and most areas previously identified as challenging, despite the concurrent reduction in the duration of the O&G attachment. CONCLUSIONS: Applying the CIPP model for evaluation to our revised QI programme enabled streamlining of procedures to achieve greater efficiency without compromising the quality of the learning experience, or increasing pressure on staff. A four week clinical rotation is adequate for medical educators to consider opportunities for including QI projects as part of student experiential learning.