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.

Rates of Maori women receiving surgical treatment for urinary incontinence and pelvic organ prolapse in Southern District Health Board.

AIMS: Pelvic organ prolapse (POP) and urinary incontinence (UI) are common gynaecological conditions that are amenable to surgical management. The prevalence of these conditions has not been well studied in the New Zealand population, but limited evidence suggests that Maori women are likely to have a higher prevalence of POP and UI than non-Maori women. The aim of this study was to formally document the rate of access to these surgical procedures for Maori and non-Maori women in the area served by Southern District Health Board (SDHB). METHODS: A retrospective descriptive study of women who underwent surgical management for POP and/or UI at SDHB facilities between 2015 and 2019 was performed. RESULTS: Unadjusted results suggested that there was a difference in the accessibility of operations for Maori and non-Maori. However, standardisation for the difference in the age structures of the two populations showed that Maori and non-Maori women access gynaecological surgery for POP and UI at very similar rates. CONCLUSIONS: We have documented that the standardised rates for Maori and non-Maori women accessing POP and UI surgery are similar in SDHB. Owing to the likely greater prevalence of these conditions in Maori women, the near equality of standardised rates of surgical intervention is likely to represent an inequity of access for Maori women.

What does abortion law reform mean for primary care practitioners in New Zealand?

New Zealand achieved a major sexual reproductive health and rights milestone when abortion ceased to be a crime. Introduction of the Abortion Legislation Act 2020 has significantly changed the way abortion care can be provided in New Zealand, with the potential to improve access, reduce inequities and transform the abortion experience for those people who choose to end their pregnancy. The primary care sector stands to be a key player in the provision of first-trimester abortion care. However, with issues relating to funding, training and access to medications yet to be resolved, the health sector is not yet ready to provide best-practice abortion care within the new legislative framework.

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 Before School Check (B4SC): reporting outcomes and referral rates for all New Zealand children.

AIMS: Describe the data obtained through the Before School Check (B4SC) and report on the outcomes and referral rates of the B4SC measures. METHODS: Cross-sectional study of B4SC data collected between January 2012 and December 2016. RESULTS: After excluding duplicate entries, 287,572 children from the B4SC database were included for analysis. Two or more significant developmental concerns (assessed by the by Parental Evaluation of Developmental Status (PEDS) questionnaire) were identified in 14,177 (4.9%) children. Less than four percent (n=10,941) of children had abnormal Strengths and Difficulties Questionnaire (SDQ) scores of 17 or more, indicating concerns about emotional and behavioural development. Eight percent of children (n=24,147) had BMIs in the 98th centile or above. Only half (56%) the number of children meeting the criteria for referral in the PEDS and SDQ assessments were referred or already under care. A quarter (25.2%) of all children in areas with the highest deprivation scores were referred for further assessment in at least one of the measured domains compared with 14% of children in areas with the lowest deprivation scores. CONCLUSIONS: The B4SC database provides an overview of the development of four-year-old children in New Zealand. Less than 5% of children had abnormal scores in assessments that measure neurodevelopment, however not all children who met the referral criteria were referred to other health services. Rates of referral increased with increasing deprivation score.

Developmental outcomes at age four following maternal antiepileptic drug use.

We investigated whether prenatal antiepileptic drug (AED) exposure was associated with adverse outcomes in the Before School Check (B4SC) assessments, particularly the assessments measuring neurodevelopment. Children exposed to AEDs were identified by linking women dispensed AEDs in the Pharmaceutical Collection to births recorded on the National Minimum Dataset (NMDS). Multinomial logistic regression was used to estimate adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) for outcomes of the parent-completed Parental Evaluation of Developmental Status (PEDS) questionnaire and Strengths and Difficulties Questionnaire (SDQ), after adjusting for gender, ethnicity, and socioeconomic deprivation. Between 2012 and 2016, 606 children with a mother who had been dispensed one or more AEDs during pregnancy had taken part in the B4SC. Prenatal exposure to sodium valproate (n = 161) or lamotrigine (n = 149) monotherapy was associated with an increased risk of having an abnormal SDQ - parent-completed (SDQP) score, ≥17 - indicating emotional or behavioral concerns (9.32% of children exposed to sodium valproate monotherapy had an abnormal score; aRR: 2.11; 1.23-3.63; lamotrigine 8.05%; aRR: 2.21; 1.21-4.02). Prenatal exposure to carbamazepine monotherapy (n = 201) was not associated with an increased risk of having an abnormal total SDQP score but was associated with increased risks in the individual domains of the SDQP. Prenatal exposure to AED polytherapy (n = 57) was associated with the highest risk of abnormal SDQP scores (17.54% of children exposed to polytherapy had abnormal scores; aRR: 2.75; 1.25-6.02). Prenatal exposure to sodium valproate and lamotrigine is associated with an increased risk of concerns about emotional and behavioral development being reported by parents in a neurodevelopmental screening program. Additional investigation is required into why significant differences between AEDs were not seen in this study.

Oral Riboflavin to Assess Ureteral Patency During Cystoscopy: A Randomized Clinical Trial.

OBJECTIVE: To evaluate whether oral riboflavin is more effective than placebo as a marker of ureteric patency at cystoscopy. METHODS: Patients scheduled for gynecologic surgery where cystoscopy was a planned component of the procedure were randomized to receive riboflavin 400 mg or placebo orally the night before surgery. During cystoscopy, the operating surgeon visualized ureteric jets and video recorded the cystoscopy portion of the procedure. The primary outcome was to determine whether orally administered riboflavin produced stronger yellow color of urine seen on cystoscopy than placebo on a 3-point scale. Secondary outcomes were to assess whether riboflavin administration improved ease of identifying ureteric jets (5-point scale) and whether a greater proportion of patients had both ureteric jets visualized with riboflavin compared with placebo. A sample size of 33 per group was planned. RESULTS: From June 28, 2017, to February 19, 2018, 72 women were screened and 66 were randomized, with 33 patients in each study group. The groups were similar in age, weight, body mass index, and ethnicity. The patients in the riboflavin group had significant increase of yellow-colored urine as rated by the operating surgeon, with a median of 2 compared with 1 on a 3-point scale (P<.001). The ureteral jets were more easily visualized in the riboflavin group as rated by the operating surgeon, with a median of 5 compared with 4 on a 5-point scale (P<.013). Bilateral ureteral patency was confirmed in 30 of 33 women (91%) in the riboflavin group and in 28 of 33 women (85%) in the placebo group (P=.71). CONCLUSIONS: The administration of riboflavin before gynecologic surgery improves the ease of visualizing the ureteric jets by inducing yellow coloration of the urine. CLINICAL TRIALS REGISTRATION: Australian New Zealand Clinical Trials Registry, 12616001367437.

Antiepileptic drug exposure in pregnancy and pregnancy outcome from national drug usage data.

BACKGROUND: Antiepileptic drugs (AEDs) are used by pregnant women to manage conditions such as epilepsy and bipolar disorder even though they pose a risk to the developing foetus. This study aimed to determine the overall use of AEDs by women during their childbearing years and women who are pregnant and the association between AED use and rates of pregnancy termination and spontaneous abortion. METHODS: Retrospective population based cohort study using administrative databases in New Zealand between 2008 and 2014. Women who had been pregnant were identified by the National Minimum Dataset and were linked to the Pharmaceutical Collection to obtain information on use of AEDs. Women aged between 15 and 45 years dispensed AEDs were identified in the Pharmaceutical Collection. RESULTS: There was an increase in the number of women of child-bearing potential prescribed AEDs, from 9 women per 1000 women in 2008 to 11.4 women per 1000 women in 2014. Women who had been dispensed an AED had an increased rate of spontaneous abortion 8.97 spontaneous abortions per 100 pregnancies, compared with, 6.31 per 100 pregnancies (risk ratio 1.42, 95% CI 1.40 to 1.44), and a decreased rate of pregnancy termination, 18.51 terminations per 100 pregnancies compared with 19.58 per 100 pregnancies (risk ratio 1.95, 95% CI 0.94-0.96). CONCLUSION: Use of newer AEDs is increasing in women of child-bearing potential in New Zealand leading to an overall increase in AED use in this group despite a fall in the use of older AEDs. AED use is this study was associated with an increased risk of spontaneous abortion and decreased rate of pregnancy termination, however confounding by indication could not be excluded.

Are doses of lamotrigine or levetiracetam adjusted during pregnancy?

Subtherapeutic levels of lamotrigine and levetiracetam are more likely to occur during pregnancy owing to the effect of pregnancy on their pharmacokinetics. This can lead to suboptimal control of epilepsy, and guidelines recommend proactive dose adjustment in the second and third trimesters alongside therapeutic drug monitoring (TDM). This retrospective cohort study using administrative databases aimed to investigate whether prescribers adjust the dose of lamotrigine or levetiracetam during and after pregnancy and whether TDM is used to manage dose adjustment. In 460 individual pregnancies, 232 women (61.4%) had their lamotrigine dose increased in the second and third trimesters and 44 women (53.7%) had their levetiracetam dose increased. Only 57 women (12.4%) had any TDM. The dose was not always decreased postpartum, and 157 women (56.9% of those who had escalated doses during pregnancy) had dose reduced following birth. Between 2012 and 2015, 29 women had an epilepsy-coded hospital discharge during pregnancy and were more likely to have had their dose of lamotrigine or levetiracetam increased. Overall, doses of lamotrigine and levetiracetam were not increased during pregnancy in 40% of the study population, dose changes were not often guided by TDM, and doses were not always reduced postpartum.

Patient-targeted Googling and social media: a cross-sectional study of senior medical students.

BACKGROUND: Social media and Internet technologies present several emerging and ill-explored issues for a modern healthcare workforce. One issue is patient-targeted Googling (PTG), which involves a healthcare professional using a social networking site (SNS) or publicly available search engine to find patient information online. The study's aim was to address a deficit in data and knowledge regarding PTG, and to investigate medical student use of SNSs due to a close association with PTG. METHOD: The authors surveyed final year medical students at the Otago Medical School, University of Otago in January 2016. A subset completed focus groups that were analysed using thematic analysis to identify key themes relating to students' attitudes towards PTG, and reasons why they might engage in PTG. RESULTS: Fifty-four students completed the survey (response rate = 65.1%), which showed that PTG was uncommon (n = 9, 16.7%). Attitudes were varied and context dependent. Most participants saw problems with PTG and favoured more explicit guidance on the issue (n = 29, 53.7%). SNS usage was high (n = 51, 94.4%); participants were concerned by the content of their SNS profiles and who they were connecting with online. Participants showing high SNS use were 1.83 times more likely to have conducted PTG than lower use groups. CONCLUSIONS: The diverse attitudes uncovered in this study indicated that teaching or guidelines could be useful to healthcare professionals considering PTG. Though ethically problematic, PTG may be important to patient care and safety. The decision to conduct PTG should be made with consideration of ethical principles and the intended use of the information.

Using Three-Dimensional Printing to Fabricate a Tubing Connector for Dilation and Evacuation.

BACKGROUND: This is a proof-of-concept study to show that simple instrumentation problems encountered in surgery can be solved by fabricating devices using a three-dimensional printer. The device used in the study is a simple tubing connector fashioned to connect two segments of suction tubing used in a surgical procedure where no commercially available product for this use is available through our usual suppliers in New Zealand. MATERIALS AND METHODS: A cylindrical tubing connector was designed using three-dimensional printing design software. The tubing connector was fabricated using the Makerbot Replicator 2X three-dimensional printer. The connector was used in 15 second-trimester dilation and evacuation procedures. Data forms were completed by the primary operating surgeon. Descriptive statistics were used with the expectation that the device would function as intended in all cases. EXPERIENCE: The three-dimensional printed tubing connector functioned as intended in all 15 instances. CONCLUSION: Commercially available three-dimensional printing technology can be used to overcome simple instrumentation problems encountered during gynecologic surgical procedures.

Uterine Scar Dehiscence Associated with Misoprostol Cervical Priming for Surgical Abortion: A Case Report.

BACKGROUND: Cervical priming prior to pregnancy termination is a common treatment. Both osmotic agents such as laminaria and Dilapan or pharmacologic agents such as misoprostol and mifepristone have been used for this purpose. CASE: A 30-year-old patient with a previous cesarean delivery was undergoing surgical termination of pregnancy at 13 weeks' gestation for a lethal fetal malformation. During preoperative cervical priming with misoprostol the uterine scar dehisced. Interval laparoscopic repair was performed. CONCLUSION: Uterine scar dehiscence can occur with misoprostol preoperative cervical priming for second trimester surgical termination of pregnancy.

Shoulder dystocia: management and documentation.

Shoulder dystocia is an obstetric emergency that occurs when the fetal shoulders become impacted at the pelvic inlet. Management is based on performing maneuvers to alleviate this impaction. A number of protocols and training mnemonics have been developed to assist in managing shoulder dystocia when it occurs. This article reviews the evidence regarding the performance, timing, and sequence of these maneuvers; reviews the mechanism of fetal injury in relation to shoulder dystocia; and discusses issues concerning documentation of the care provided during this obstetric emergency.

Log-linear human chorionic gonadotropin elimination in cases of retained placenta percreta.

PURPOSE: To describe the human chorionic gonadotropin (hCG) elimination rate in patients with intentionally retained placenta percreta. METHODS: Medical records for cases of placenta percreta with intentional retention of the placenta were reviewed. The natural log of the hCG levels were plotted versus time and then the elimination rate equations were derived. RESULTS: The hCG elimination rate equations were log-linear in three cases individually (R (2) = 0.96-0.99) and in aggregate R (2) = 0.92). The mean half-life of hCG elimination was 146.3 h (6.1 days). CONCLUSION: The elimination of hCG in patients with intentionally retained placenta percreta is consistent with a two-compartment elimination model. The hCG elimination in retained placenta percreta is predictable in a log-linear manner that is similar to other reports of retained abnormally adherent placentae treated with or without methotrexate.

Glove perforations with blunt versus sharp surgical needles in caesarean delivery: a randomized trial.

AIMS: To compare the rate of glove perforations and surgeon satisfaction when utilizing blunt surgical needles compared to conventional sharp surgical needles. METHODS: Patients undergoing Caesarean delivery were randomly assigned to the use of blunt or sharp surgical suture needles. Surgical team members reported any known needlesticks or perforations of gloves and the primary surgeon completed a survey to gauge their satisfaction with the needles. Glove perforation was assessed by suspending gloves and filling with water. The chi-square test was used to assess categorical variables and the Mann-Whitney U-test was used to assess ordinal data. RESULTS: A total 240 patients were enrolled into the study. There was no statistically significant difference in the rate of glove perforation per case between groups assigned to sharp (24%) or blunt surgical needles (26%). (RR 1.05, 95% CI 0.68-1.63). There were significant differences in the surgeon satisfaction surveys, with surgeons in the sharp needle group being more satisfied with the tissue penetration of the needle (p < .001), needle integrity (p = .01), force to penetrate tissue (p < .001) and control of bleeding at the needle insertion site (p = .001). Surveys from surgeons in the blunt needle group showed a statistically significant improvement in the perceived safety profile of the blunt needles (p < .001) CONCLUSIONS: There was no significant difference in the rate of glove perforation between blunt and sharp surgical needles during Caesarean delivery. Overall surgeons were more satisfied with the sharp surgical needles.

Plasma and tissue cefazolin concentrations in obese patients undergoing cesarean delivery and receiving differing pre-operative doses of drug.

BACKGROUND: Patients undergoing cesarean delivery typically receive a 1-g to 2-g dose of cefazolin as pre-operative antibacterial prophylaxis. This traditional dosage may not provide an adequate tissue concentration of cefazolin in obese patients during the peri-operative period. This study compared the tissue concentrations of prophylactic cefazolin administered as a either a 2-g or a 4-g dose prior to cesarean delivery in obese patients. METHODS: Twenty obese patients (first trimester body mass index [BMI] >35) who underwent cesarean delivery completed this randomized study. Eleven patients received 2 g of cefazolin, and nine received 4 g. Blood and subcutaneous tissues were collected at the times of the incision and closure. Myometrial biopsies were collected at uterine closure. A cefazolin concentration threshold of 4 mcg/g for tissue samples was used as a surrogate adequate concentration. Plasma and tissue cefazolin concentrations were compared for the two doses. RESULTS: Mean plasma, umbilical cord, and myometrial cefazolin concentrations were significantly higher in the 4-g treatment group (p<0.05). Subcutaneous incision site tissue obtained at time of incision creation also was significantly higher in the 4-g group than in the 2-g group (40.11±24.10 mcg/g vs. 18.36±6.68 mcg/g; p=0.0005). Subcutaneous tissue concentrations at closure were significantly different in the two dosage groups (34.89±17.42 mcg/g vs. 21.73±16.02 mcg/g; p=0.044). All tissue samples were above the target of 4 mcg/g. Body morphometry did not correlate with the variability in cefazolin tissue concentration. No surgical site infections, endometritis, or other adverse effects were observed. CONCLUSIONS: Administering a prophylactic dose of 4 g of cefazolin produced blood and tissue cefazolin concentrations that were significantly higher than concentrations obtained from a 2-g dose in patients with BMIs between 35 and 60 kg/m(2) undergoing cesarean delivery. It is unclear if the larger cefazolin dose produces a more protective anti-infective effect than that obtained with the more traditional 2-g dose for cesarean delivery in obese patients.

Laparoscopic removal of a large ovarian mass utilizing planned trocar puncture.

BACKGROUND: Large cystic ovarian masses pose technical challenges to the laparoscopic surgeon. Removing large, potentially malignant specimens must be done with care to avoid the leakage of cyst fluid into the abdominal cavity. CASE: We present the case of a large ovarian cystic mass treated laparoscopically with intentional trocar puncture of the mass to drain and remove the mass. DISCUSSION: Large cystic ovarian masses can be removed laparoscopically with intentional trocar puncture of the mass to facilitate removal without leakage of cyst fluid.

Chronic postpartum uterine inversion treated by abdominal replacement and cerclage.

BACKGROUND: Chronic uterine inversion is a potentially dangerous condition that often requires abdominal surgical reduction of the uterine inversion. Uterine inversion can recur after successful uterine replacement. CASE: A young primagravida presented with chronic recurrent uterine inversion 5 weeks after spontaneous vaginal delivery. The uterus was replaced abdominally and an abdominal cervical cerclage was placed to prevent recurrent inversion. CONCLUSION: Abdominal cervical cerclage can be utilized after treatment of chronic recurrent uterine inversion to prevent future recurrence of uterine inversion.

Unruptured 32-week rudimentary horn pregnancy presenting as right upper quadrant pain.

BACKGROUND: An unruptured third trimester rudimentary horn pregnancy is rare, life threatening, and can go undetected until the onset of symptoms. Given the high risk of uterine rupture, conservative management after viability is controversial. CASE: A 21 year-old with a 32-week rudimentary horn pregnancy, diagnosed via exploratory laparotomy five days earlier, presented with acute right upper quadrant pain. The patient underwent cesarean delivery. The rudimentary horn was noted to be intact, but so thin it was transparent. CONCLUSION: Advanced ectopic pregnancy or rudimentary horn pregnancy should be considered in cases of unusual or undiagnosed abdominal pain in pregnancy. When surgical exploration is performed, an incision allowing optimal visualization and exposure is recommended.