Outpatient versus inpatient management of preterm prelabor rupture of membranes: A systematic review and meta-analysis.

INTRODUCTION: To compare neonatal, obstetrical, and maternal outcomes associated with outpatient versus inpatient management of pregnancies with preterm prelabor rupture of membranes (PPROM). MATERIAL AND METHODS: A search of MEDLINE, EMBASE, the Cochrane Database and Central Register from January 1, 1990 to July 31, 2023 identified randomized controlled trials (RCTs) and cohort studies comparing outpatient with inpatient management for pregnant persons diagnosed with PPROM before 37 weeks' gestation. No language restriction was applied. We applied a random effects model for meta-analysis. Trustworthiness was assessed using recently published guidance and Risk of bias using the RoB 2.0 tool for RCTs and ROBINS-I tool for cohort studies. The Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach was used to assess the certainty of evidence (COE). Outcomes of interest included perinatal mortality, neonatal morbidities, latency and gestational age at delivery, and maternal morbidities. RCTs and cohort studies were analyzed separately. This study was registered in the International Prospective Register of Systematic Reviewsr: CRD42022295275. RESULTS: From 2825 records, two RCTs and 10 cohort studies involving 1876 patients were included in the review and meta-analysis. Outpatient management protocols varied but generally included brief initial hospitalization, strict eligibility criteria, and surveillance with laboratory and ultrasound investigations. Outpatient management showed lower rates of neonatal respiratory distress syndrome (cohort: RR 0.63 [0.52-0.77, very low COE]), longer latency to delivery (RCT: MD 7.43 days [1.14-13.72 days, moderate COE], cohort: MD 8.78 days [2.29-15.26 days, low COE]), higher gestational age at birth (cohort: MD 7.70 days [2.02-13.38 days, low COE]), lower rates of Apgar scores <7 at 5 min of life (cohort: RR 0.66 [0.50-0.89, very low COE]), and lower rates of histological chorioamnionitis (cohort: RR 0.74 [0.62-0.89, low COE]) without increased risks of adverse neonatal, obstetrical, or maternal outcomes. CONCLUSIONS: Meta-analysis of data from RCTs and cohort studies with very low-to-moderate certainty of evidence indicates that further high-quality research is needed to evaluate the safety and potential benefits of outpatient management for selected PPROM cases, given the moderate-to-high risk of bias in the included studies.

Pregnancy and childbirth during incarceration: A qualitative systematic review of lived experiences.

BACKGROUND: Incarcerated individuals who experience pregnancy or childbirth in correctional facilities face unique considerations for obstetric care and consequently are at greater risk of adverse maternal and fetal outcomes. OBJECTIVES: To characterise patient experiences regarding pregnancy and childbirth during incarceration via qualitative synthesis. SEARCH STRATEGY: Medline-OVID, EMBASE, CINAHL, Sociological Abstracts, Social Work Abstracts, Web of Science, Scopus and PsycInfo were systematically searched from inception to 24 December 2020. Supplementary searches were performed using the Scopus database. SELECTION CRITERIA: Only original, peer-reviewed literature was examined. Eligible studies were assessed using the Joanna Briggs Institute Critical Appraisal Checklist for Qualitative Research. RESULTS: After screening 4173 original database citations, 24 studies that met inclusion criteria were included and analysed via thematic analysis. The 24 studies included perspectives from 645 female patients who had experienced incarceration, 69 healthcare providers and 70 prison staff. Key patient-reported concerns for the well-being of pregnant individuals during incarceration included mental health challenges, dehumanisation of prenatal care and delivery, lack of privacy, stigma, psychological trauma, lack of emotional support and shackle usage during pregnancy and/or labour. The studies reported a lack of support for patients to access female correctional officers or guards, privacy during intimate examinations, timely medical care and support for breastfeeding. Above all, the psychological trauma of separation from one's newborn after birth was of utmost devastation. CONCLUSIONS: Our systematic review highlights the dire need for accountability and interventions to improve pregnancy and childbirth care for incarcerated individuals. TWEETABLE ABSTRACT: This systematic review describes lived experiences of pregnancy & childbirth during incarceration, including dehumanisation, psychological trauma, and use of shackles.

Determining the optimal antibiotic regimen for chorioamnionitis: A systematic review and meta-analysis.

INTRODUCTION: To evaluate the effect of antibiotic regimens for chorioamnionitis on maternal and neonatal outcomes. MATERIAL AND METHODS: We conducted a systematic review, wherein we searched six bibliographic databases until June 2020 and included randomized clinical trials describing antibiotic regimens for treating chorioamnionitis. Risk of bias was assessed using the Cochrane Risk of Bias tool V2.0. Random-effects meta-analysis was performed and results were presented as risk ratio (RR) and mean differences (MD) with 95% CI. RESULTS: Fourteen trials at low-to-high risk of bias were included. Three trials (n = 244), comparing different intrapartum antibiotic regimens, showed no difference in outcomes except for lower composite maternal morbidity (endometritis, pneumonia, sepsis, blood transfusion, and ileus) with ampicillin/sulbactam vs ampicillin/gentamicin in one study (0/43 vs 6/49, P = .03). Three trials (n = 295) comparing different doses of intrapartum antibiotics showed no differences in maternal and neonatal outcomes, although one study showed a shorter duration of antibiotic treatment in the experimental arm (4 mg/kg gentamicin q24h + 1200 mg clindamycin q12h) vs conventional arm (1.33 mg/kg gentamicin + 800 mg clindamycin q8h) (48.0 ± 36 hours vs 55.2 ± 48 hours, P = .04). Four trials (n = 484) comparing postpartum antibiotics vs no antibiotics showed no difference in outcomes except for a shorter hospital stay (two studies, MD -7.90 hours, 95% CI -13.52 to -2.27 hours). Three trials (n = 447) comparing single vs multiple doses of postpartum antibiotics showed shorter hospital stay [MD -19.14 hours, 95% CI -29.88 to -8.41 hours), but no differences in treatment failure (RR 1.73, 95% CI 0.69-4.30) or total antibiotic dose (MD -9.24, 95% CI -19.49 to 1.01). One trial (n = 48) comparing intrapartum vs postpartum initiation of treatment found benefits to intrapartum (vs postpartum) initiation of antibiotics, in terms of postpartum maternal hospital stay (MD -24 hours, 95% CI -45.56 to -1.44 hours), neonatal hospital stay (MD -45.6 hours, -93.84 to -11.76 hours), and neonatal pneumonia or sepsis (RR 0.06, 95% CI 0.00-0.95). CONCLUSIONS: Upon diagnosis of chorioamnionitis, there is limited evidence to recommend the prompt initiation of intrapartum antibiotics, and to consider a single dose of postpartum antibiotics over multiple doses or no treatment. Well-designed trials using standard definitions of chorioamnionitis, outcome measures, and newer antibiotics are required to inform clinical practice with regard to the preferred antibiotic regimen, dose, and duration to optimize maternal and neonatal outcomes.

Correction to: Inpatient versus outpatient induction of labour: a systematic review and metaanalysis.

An amendment to this paper has been published and can be accessed via the original article.

Inpatient versus outpatient induction of labour: a systematic review and meta-analysis.

BACKGROUND: As the number of indications for labour induction continue to increase, the focus has shifted to performing these procedures in an outpatient setting. This study aims to systematically review published data from randomized controlled trials that compare outpatient with inpatient labour induction, to ascertain the role of outpatient labour induction for low-risk pregnancies. METHODS: We conducted a systematic review wherein we searched MEDLINE, EMBASE, Biosis Previews®, and International Pharmaceutical Abstracts from inception to January 2020 to identify randomized controlled trials that reported on maternal, fetal and resource-related outcomes following outpatient versus inpatient labour induction. Pooled incidences and mean differences were calculated using random-effects meta-analysis. Risk-of-bias was assessed using the Cochrane Risk of Bias tool. Subgroup analysis was conducted based on the method of induction. RESULTS: Of the 588 records identified, 12 publications, representing nine independent randomized controlled trials conducted in Australia, Europe and North America, were included. These reported on 2615 cases of labour induction (1320 outpatients versus 1295 inpatients). Overall, apart from a higher number of suspicious fetal heart rate tracings [RR = 1.43 (1.10, 1.86)] and a shorter mean length of hospital stay [MD = 282.48 min (160.23, 404.73) shorter] in the outpatient group, there were no differences in delivery method, adverse outcomes or resource-use between the two arms. On subgroup analysis, when comparing the use of balloon catheters in both arms, those induced as outpatients had fewer caesarean deliveries [RR = 0.52 (0.30, 0.90)], a shorter admission-to-delivery interval [MD = 370.86 min (19.19, 722.54) shorter], and a shorter induction to delivery interval [MD = 330.42 min (120.13, 540.71) shorter]. CONCLUSION: Outpatient labour induction in resource-rich settings is at least as effective and safe, in carefully selected patient populations, when compared with inpatient labour induction. Whether outpatient labour induction results in lower rates of caesarean deliveries needs to be explored further. TRIAL REGISTRATION: This systematic review was prospectively registered in Prospero ( CRD42019118049 ).

The use of loop diuretics in the context of hypertensive disorders of pregnancy: a systematic review and meta-analysis.

AIMS: Addressing volume expansion may improve the management of hypertension across the pregnancy continuum. We conducted a systematic review to summarize the evidence on the use of loop diuretics in the context of hypertensive disorders during pregnancy and the postpartum period. METHODS AND RESULTS: Medline, Embase, Cochrane library, ClinicalTrials.gov, and Google Scholar were searched for original research articles published up to 29 June 2021. Of the 2801 results screened, 15 studies were included: eight randomized controlled trials, six before-after studies, and one cohort study. Based on random effects meta-analysis of before-after studies, antepartum use of loop diuretics was associated with lower DBP [mean difference -17.73 mmHg, (95% confidence intervals -34.50 to -0.96); I2 = 94%] and lower cardiac output [mean difference -0.75 l/min, (-1.11 to -0.39); I2 = 0%], with no difference in SBP, mean arterial pressure, heart rate, or total peripheral resistance. Meta-analysis of randomized controlled trials revealed that postpartum use of loop diuretics was associated with decreased need for additional antihypertensive patients [relative risk 0.69, (0.50-0.97); I2 = 14%], and an increased duration of hospitalization [mean difference 8.80 h, (4.46-13.14); I2 = 83%], with no difference in the need for antihypertensive therapy at hospital discharge, or persistent postpartum hypertension. CONCLUSION: Antepartum use of loop diuretics lowered DBP and cardiac output, while their postpartum use reduced the need for additional antihypertensive medications. There was insufficient evidence to suggest a clear benefit. Future studies focusing on women with hypertensive pregnancy disorders who may most likely benefit from loop diuretics are required.

Induction of labour in low-risk pregnancies before 40 weeks of gestation: A systematic review and meta-analysis of randomized trials.

This systematic review of 16 randomized trials, which included 8796 pregnancies, did not demonstrate a reduction in caesarean births or perinatal morbidity from induction of labour (IoL) at 39-40 weeks for non-medical indications. However, IoL at 39-40 weeks may be associated with a lower incidence of maternal hypertensive disorders, a shorter duration of the first stage of labour, fewer instances of meconium-stained amniotic fluid, lower mean birth weights, longer duration of (maternal) hospitalization, and higher epidural usage. Until regional data on clinical benefits, resource implications and long-term impact are available, a prudent approach would be to encourage shared decision-making, wherein birthing persons with low-risk pregnancies are given the opportunity to assess the risks and benefits of IoL at 39-40 weeks over expectant management and allowed to consider their decision in the light of their values and preferences and local resource availability.

Inconsistencies in the Methodological Framework Throughout Published Studies in High-Impact Orthopaedic Journals: A Systematic Review.

BACKGROUND: Both the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines recommend that clinical trials follow a study framework that aligns with their objective to test the relative efficacy or safety (equality) or effectiveness (superiority, noninferiority, or equivalence) between interventions. We conducted a systematic review to assess the proportion of studies that demonstrated inconsistency between the framing of their research question, sample size calculation, and conclusion and those that should have framed their research question differently based on the compared interventions. METHODS: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 interventions using patient-reported outcome measures. RESULTS: We included 228 studies. The sample size calculation was reported in 60.5% (n = 138) of studies. Of these, 52.2% (n = 72) were inconsistent between the framing of their research question, sample size calculation, and conclusion. The majority (n = 137) of sample size calculations were for equality, but 43.8% of these studies concluded superiority, noninferiority, or equivalence. Studies that framed their research question as equality (n = 186) should have been framed as superiority (n = 129), equivalence (n = 52), or noninferiority (n = 3). Only 2 studies correctly framed their research question as equality. CONCLUSIONS: Studies published in high-impact journals were inconsistent between the framing of their research question, sample size calculation, and conclusion. Authors may be misinterpreting research findings and making clinical recommendations solely based on p values. Researchers are encouraged to state and justify their methodological framework and choice of margin(s) in a publicly published protocol as they have implications for sample size and the applicability of conclusions. CLINICAL RELEVANCE: The results of clinical research must be interpreted using confidence intervals, with careful consideration as to how the confidence intervals relate to clinically meaningful differences in outcomes between treatments. The more typical practice of relying on p values leaves the clinician at high risk of erroneous interpretation, recommendation, and/or action.

The Postsurgical Clavien-Dindo Classification in Minor Surgery Can Improve Perception and Communication (Investigation on Blepharoplasty).

The postsurgical Clavien-Dindo classification in minor surgery can improve perception and communication (Investigation on Blepharoplasty). Background: Minor surgery lacks a standardized postoperative complication classification. This leads to the presentation of inaccurate postsurgical complication rates and makes comparisons challenging, especially for patients seeking information. This study aims to evaluate a standardized five-step complication grading system (Clavien-Dindo Classification, CDC) on the example of blepharoplasty, which is the most performed minor aesthetic surgery worldwide. Methods: A retrospective observational exploratory study of patients (N = 344) who received a bilateral upper eyelid blepharoplasty under local anesthesia from the same surgical staff was performed. Data were retrieved from the electronic patient record: the CDC grading and the surgeon-reported complications (N = 128) at the first follow-up on day 7. In addition, a telephone survey with patients (N = 261) after 6 months was performed, which consisted of 7 complication-related yes/no questions. Results: Based on the CDC, 41.6% of patients were classified as having no complications, and 58.4% had one. Furthermore, 1 patient (0.3%) received a revision under general anesthesia (CDC IIIb), 18 patients (5.2%) were re-operated under local anesthesia (CDC IIIa), 23 patients (6.7%) required pharmacological intervention (CDC II), and 159 patients (46.2%) had a complication from the normal postoperative course and received supportive treatment (CDC I). Moreover, 90.5% of the mentioned complications accounted for Grade I and II; 94% of the patients subjectively experienced no complications; 51% of patients were pleased with the surgery even though a complication occurred according to the CDC; 34% of complications escaped the awareness of the surgeon. Conclusions: Grade I and II complications occurred frequently. Complications escaped the perception of the patients and surgeons. The classification identifies a wide variety of postsurgical complications and allows a standardized comparison in minor surgery objectively. Potential: The CDC in minor procedures can improve the (institutional) preoperative communication with patients regarding potential postoperative expectations. Furthermore, the classification can be a useful tool to detect complication-related costs, identify insurance-related requests, and support evidence in medicolegal disputes. The example of blepharoplasty can be translated to various other and even less invasive procedures.

Interpreting Patient-Reported Outcome Measures in Orthopaedic Surgery: A Systematic Review.

BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) Statement recommends that studies report results beyond p values and include treatment effect(s) and measures of precision (e.g., confidence intervals [CIs]) to facilitate the interpretation of results. The objective of this systematic review was to assess the reporting and interpretation of patient-reported outcome measure (PROM) results in clinical studies from high-impact orthopaedic journals, to determine the proportion of studies that (1) only reported a p value; (2) reported a treatment effect, CI, or minimal clinically important difference (MCID); and (3) offered an interpretation of the results beyond interpreting a p value. METHODS: We included studies from 5 high-impact-factor orthopaedic journals published in 2017 and 2019 that compared at least 2 intervention groups using PROMs. RESULTS: A total of 228 studies were analyzed, including 126 randomized controlled trials, 35 prospective cohort studies, 61 retrospective cohort studies, 1 mixed cohort study, and 5 case-control studies. Seventy-six percent of studies (174) reported p values exclusively to express and interpret between-group differences, and only 22.4% (51) reported a treatment effect (mean difference, mean change, or odds ratio) with 95% CI. Of the 54 studies reporting a treatment effect, 31 interpreted the results using an important threshold (MCID, margin, or Cohen d), but only 3 interpreted the CIs. We found an absolute improvement of 35.5% (95% CI, 20.8% to 48.4%) in the reporting of the MCID between 2017 and 2019. CONCLUSIONS: The majority of interventional studies reporting PROMs do not report CIs around between-group differences in outcome and do not define a clinically meaningful difference. A p value cannot effectively communicate the readiness for implementation in a clinical setting and may be misleading. Thus, reporting requirements should be expanded to require authors to define and provide a rationale for between-group clinically important difference thresholds, and study findings should be communicated by comparing CIs with these thresholds.

Pregnancy outcomes in women with cardiothoracic transplants: A Systematic review and meta-analysis.

Increasing numbers of women with thoracic transplants are planning and continuing pregnancies. However, pregnancy outcomes and risks to the mother and baby have not been systematically assessed. MEDLINE, EMBASE, and Cochrane Central were searched from their inception to January 2018, to identify studies reporting outcomes on 3 or more pregnancies following thoracic transplants. Pooled incidences were calculated using a random-effect meta-analysis. Risk-of-bias was assessed using the Joanna Briggs Checklist for case series. Subgroup analysis was conducted based on the organ transplanted. Of the 3,658 records identified, 12 studies were included that reported on 385 pregnancies in 272 thoracic transplant recipients. Maternal complications included mortality (pooled incidence 0.5% [95% confidence intervals 0, 1.1%] during pregnancy and 15.4% [10.4, 20.3%] during follow-up, which ranged between 3 and 7 years), graft rejection (7.4% [4.2, 10.5%]), hypertensive disorders of pregnancy [26.6% [13.7, 39.6%]), and cesarean deliveries (41.4% [33.4, 48.7%]). Maternal mortality was more common in recipients of lung vs heart transplants (41.4% [23.4, 59.3] vs 10.8% [5.9, 15.8]), respectively. Although 78.4% (69.8, 86.9%) of the pregnancies resulted in live births, 51.2% (31, 71.3%) were born preterm and neonatal deaths occurred in 3.4% (1.3, 5.6%). Congenital anomalies affected 4.3% (1.8, 6.8%) of the newborns. Although few maternal deaths occurred during pregnancy, in keeping with median survival data, delayed mortality for thoracic transplant recipients remains high. Despite the high numbers of live births, these pregnancies continue to be at risk for hypertensive disorders, graft rejection, preterm birth, and neonatal mortality. Prospectively gathered data from international registries should supplement these findings to better inform clinical counseling and practice.

Kcnj6(GIRK2) trisomy is not sufficient for conferring the susceptibility to infantile spasms seen in the Ts65Dn mouse model of down syndrome.

OBJECTIVE: Infantile spasms (IS) is a catastrophic childhood seizure disorder that is characterized by extensor and/or flexor spasms, cognitive deterioration and a characteristic EEG abnormality. The latter consists of a pattern of a spike-wave followed by an electrodecremental response (EDR), which is a flattening of the EEG waveform amplitude. The mechanism/circuitry that underpins IS is unknown. Children with Down Syndrome (DS) are particularly vulnerable to IS. The standard mouse model of DS is the Ts65Dn mutant mouse (Ts). Using the Ts mouse, we have created an animal model of IS in DS. This model entails the treatment of Ts mice with a GABABR agonist with a resultant recapitulation of the semiological, electrographic, and pharmacological phenotype of IS. One of the genes triplicated in Ts mice is the kcnj6 gene which codes for the G-protein inwardly rectifying potassium channel 2 (GIRK2) protein. We have shown that over expression of GIRK2 in Ts brain is necessary for the production of the GABABR agonist induced IS phenotype in the Ts mouse. Here, we ask the question whether the excess GIRK2 is sufficient for the production of the GABABR agonist induced IS phenotype. METHODS: To address this question, we used kcnj6 triploid mice, and compared the number of spasms via video analysis and EDR events via EEG to that of the WT mice. RESULTS: We now show that GABARR agonist-treated kcnj6 triploid mice failed to show susceptibility to the IS phenotype. Therefore, over expression of GIRK2 in the brain is necessary, but not sufficient to confer susceptibility to the GABABR agonist-induced IS phenotype in the Ts model of DS. SIGNIFICANCE: It is therefore likely that GIRK2 is working in concert with another factor or factors that are altered in the Ts brain in the production of the GABABR agonist-induced IS phenotype.