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In this randomized trial comparing delivery strategies in women with twin gestation, planned cesarean section did not significantly increase or decrease the risk of fetal or neonatal death or serious neonatal morbidity, as compared with planned vaginal delivery. Because of assisted reproductive technologies, twin pregnancy occurs more frequently now than in the past, and it complicates 2 to 3% of all births. 1 , 2 Twins are at higher risk for an adverse perinatal outcome than singletons. 3 , 4 Planned cesarean section, as compared with planned vaginal delivery, may reduce this risk. 5 Although a small, randomized, controlled trial did not show better perinatal outcomes with planned cesarean section than with planned vaginal delivery, 6 several cohort studies have shown a reduced risk of adverse perinatal outcomes for both twins, or for the second twin, when twins at or near term were delivered . . .

Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. In this multicentre, open-label, randomised controlled trial, we recruited women aged 18–40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference −0·19%; 95% CI −0·34 to −0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.

To determine the impact of pre-pregnancy diabetes mellitus (D), obesity (O) and chronic hypertension (H) on preterm birth (PTB). Retrospective population-based cohort study in Ontario, Canada between 2012-2016. Women who had a singleton livebirth or stillbirth at > 20 weeks gestation were included in the cohort. Exposures of interest were D, O and H, individually, and in various combinations. The primary outcome was PTB at 241/7 to 366/7 weeks. PTB was further analyzed by spontaneous or provider-initiated, early (< 34 weeks) or late (34-37 weeks), and the co-presence of preeclampsia, large for gestational age (LGA), and small for gestational age (SGA). Multivariable Poisson regression models with robust error variance were used to generate relative risks (RR), further adjusted for maternal age and parity (aRR). Population attributable fractions (PAF) were calculated for each of the outcomes by exposure state. 506,483 women were eligible for analysis. 30,139 pregnancies (6.0%) were complicated by PTB < 37 weeks, of which 7375 (24.5%) had D or O or H. Relative to women without D or O or H, the aRR for PTB < 37 weeks was higher for D (3.51; 95% CI 3.26-3.78) and H (3.81; 95% CI 3.55-4.10) than O (1.14; 95% CI 1.10-1.17). The combined state of DH was associated with a significantly higher aRR of PTB < 37 weeks (6.34; 95% CI 5.14-7.80) and < 34 weeks (aRR 10.33, 95% CI 6.96-15.33) than D alone. The risk of provider initiated PTB was generally higher than that for spontaneous PTB. Pre-pregnancy hypertension was associated with the highest risk for PTB with preeclampsia (aRR 45.42, 95% CI 39.69-51.99) and PTB with SGA (aRR 9.78, 95% CI 7.81-12.26) while pre-pregnancy diabetes was associated with increased risk for PTB with LGA (aRR 28.85, 95% CI 24.65-33.76). Combinations of DOH significantly magnify the risk of PTB, especially provider initiated PTB, and PTB with altered fetal growth or preeclampsia.

Jon F.R. Barrett MD Chief of Maternal-Fetal Medicine, Sunnybrook Health Sciences Centre Arthur Zaltz MD Chief of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre Michael Geary MD Chief of Obstetrics and Gynaecology, St. Michael's Hospital Mathew Sermer MD Chief of Obstetrics and Gynaecology, Mount Sinai Hospital John Kingdom MD Chair of Obstetrics and Gynaecology, University of Toronto, Toronto, Ont.

IntroductionPlacenta accreta spectrum (PAS) disorder is a life-threatening condition that may result in serious maternal complications, including mortality. The placenta which is pathologically adherent to the uterine wall, places individuals at high risk of major haemorrhage during the third stage of labour. Current research reports on PAS disorder outcomes have highly variable levels of information, which is therefore difficult for investigators to aggregate to inform practice. There is an urgent need to harmonise data collection in prospective studies to identify and implement best practices for management. One approach to standardise outcomes across any health area via the use of core outcome sets (COSs), which are consensus-derived standardised sets of outcomes that all studies for a particular condition should measure and report. This protocol outlines the steps for developing a COS for PAS disorder (COPAS).Methods and analysisThis protocol outlines steps for the creation of COPAS. The first step, a systematic review, will identify all reported outcomes in the scientific literature. The second step will use qualitative one-on-one interviews to identify additional outcomes identified as important by patients and healthcare professionals that are not reported in the published literature. Outcomes from the first two steps will be combined to form an outcome inventory. This outcome inventory will inform the third step which is a Delphi survey that encourages agreement between patients and healthcare professionals on which outcomes are most important for inclusion in the COS. The fourth step, a consensus group meeting of representative participants, will finalise outcomes for inclusion in the PAS disorder COS.Ethics and disseminationThis study has obtained Research Ethics Board approval from Sunnybrook Health Sciences Centre (#2338, #1488). We will aim to publish the study findings in an international peer-reviewed OBGYN journal.Registration detailsCOMET Core Outcome Set Registration: https://www.comet-initiative.org/Studies/Details/1127.PROSPERO registration numberCRD42020173426.

ObjectiveAn increasing proportion of fetuses are exposed to antenatal corticosteroids (ACS). Despite their immediate beneficial effects, the long-term safety of ACS has been an ongoing source of concern. In the current study, we assessed the likelihood of neurodevelopmental problems among term infants exposed to ACS earlier in pregnancy compared with non-exposed term infants.DesignRetrospective cohort study (2006–2011). Median duration of follow-up was 7.8 (IQR 6.4–9.2) years.SettingPopulation-based study, Ontario, Canada.ParticipantsAll live singleton infants born at term (≥370/7 weeks gestation) (n=529 205).ExposureACS during pregnancy.Primary and secondary outcome measuresA composite of diagnostic or billing codes reflecting proven or suspected neurodevelopmental problems during childhood including audiometry testing, visual testing or physician service claim with a diagnosis code related to a suspected neurocognitive disorder.ResultsAt 5 years of age, the cumulative rate for the primary outcome was higher among infants exposed to ACS compared with non-exposed infants: 61.7% (3346/5423) vs 57.8% (302 520/523 782), respectively (p<0.001; number needed to harm (NNH)=25, 95% CI 19 to 38; adjusted HR (aHR) 1.12, 95% CI 1.08 to 1.16). Similar findings were observed for each of the individual components of the primary outcome: 15.3% vs 12.7% for audiometry testing (p<0.001; NNH=39, 95% CI 29 to 63; aHR 1.18, 95% CI 1.11 to 1.25); 45.4% vs 43.5% for visual testing (p=0.006; NNH=54, 95% CI 31 to 200; aHR 1.08, 95% CI 1.04 to 1.12) and 25.8% vs 21.6% for suspected neurocognitive disorder (p<0.001; NNH=24, 95% CI 19 to 33; aHR 1.16, 95% CI 1.10 to 1.21).ConclusionsWe found an association among term infants between exposure to ACS during pregnancy and healthcare utilisation during childhood related to suspected neurocognitive and neurosensory disorders.

Background Preeclampsia significantly impacts maternal and perinatal health. Early screening using advanced models and primary prevention with low-dose acetylsalicylic acid for high-risk populations is crucial to reduce the disease’s incidence. This study assesses the feasibility of implementing preterm preeclampsia screening and prevention by leveraging information from our current aneuploidy screening program in a real-world setting with geographic separation clinical site and laboratory analysis site. Methods A prospective cohort study involved pregnant individuals undergoing nuchal translucency scans between 11 and 14 weeks. Risk for preterm preeclampsia was assessed using the Fetal Medicine Foundation algorithm, which includes maternal risk factors, uterine artery Doppler, mean arterial pressure and serum markers (Placental growth factor, PlGF and Pregnancy-associated plasma protein-A, PAPP-A). High-risk patients were offered low-dose acetylsalicylic acid prophylaxis. Feasibility outcomes, such as recruitment rates, protocol adherence, operational impact, integration with existing workflows, screening performance and pregnancy outcomes, were evaluated. Results Out of 974 participants, 15.6% were deemed high-risk for preterm preeclampsia. The study achieved high recruitment (82.1%) and adherence rates, with 95.4% of high-risk patients prescribed low-dose acetylsalicylic acid. Screening performance, adjusted for low-dose acetylsalicylic acid use, showed a detection rate of 88.9–90% (FPR 13.0% and 12.7%) for preterm preeclampsia. High-risk group for preeclampsia had higher incidences of adverse outcomes, including preterm preeclampsia (7.5 vs 0.4%; p  < 0.001), preterm delivery (21.2 vs 6.2%; p  < 0.001), low birth weight (23.3 vs 5.6%; p  < 0.001) and birthweight < 10th percentile (11% vs 5.6%; p  = 0.015) compared to low-risk group. The integration of preeclampsia screening had a minimal effect on the time required for aneuploidy screening, with results obtained within a rapid turnaround time. Conclusions The study confirms the feasibility of integrating comprehensive preeclampsia screening into clinical practice, notwithstanding geographic separation between laboratory and clinical settings. It underscores the need for broader adoption and enhanced infrastructure to optimize patient care and outcomes across diverse healthcare settings. Trial registration Clinical trial: NCT04412681 (2020–06-02).

Background This secondary analysis for the Twin Birth Study, an international, multicenter trial, aimed to compare the cesarean section rates and safety between methods of induction of labor in twin pregnancies. Methods Women with twin pregnancies where the first twin was in a cephalic presentation and who presented for labor induction, were non-randomly assigned to receive prostaglandin or amniotomy and/or oxytocin. Main outcome measures were the rates of unplanned cesarean section and neonatal and maternal mortality or serious morbidity. Results 153 (41.5%) were induced by prostaglandin (prostaglandin group) and 215 (58.5%) were induced by amniotomy and/or oxytocin alone (no prostaglandin group). Induction using prostaglandin was more common in countries with a low perinatal mortality rate <10/1000 (45.7 versus 32.5%, p  = 0.02). Cesarean section rates were similar in the two groups: 62/153 (40.5%) in the prostaglandin group and 87/215 (40.5%) in the no prostaglandin group (odds ratio 1, 95% CI 0.65-1.5). Nulliparity, late maternal age, non-cephalic presentation of twin B and high country’s perinatal mortality rate were found to be independently associated with the induction to end with an unplanned cesarean section. There were no significant differences between groups with respect to maternal or neonatal adverse outcomes. Conclusions The need for cervical ripening by prostaglandin had no effect on the incidence of cesarean delivery or an abnormal outcome. There is a significant risk of unplanned cesarean section independent of chosen induction method. Trial registration This trial was registered at the International Standard Randomized Controlled Trial Register (identifier ISRCTN74420086 ; December 9, 2003) and retrospectively registered at the www.clinicaltrials.gov (identifier NCT 00187369 ; September 12, 2005).

To assess the incidence of cerebral palsy among children born to mothers who had their pregnancy complicated by a motor vehicle crash. Retrospective longitudinal cohort analysis of children born from 1 April 2002 to 31 March 2012 in Ontario, Canada. Cases defined as pregnancies complicated by a motor vehicle crash and controls as remaining pregnancies with no crash. Subsequent diagnosis of cerebral palsy by age 3 years. A total of 1 325 660 newborns were analysed, of whom 7933 were involved in a motor vehicle crash during pregnancy. A total of 2328 were subsequently diagnosed with cerebral palsy, equal to an absolute risk of 1.8 per 1000 newborns. For the entire cohort, motor vehicle crashes correlated with a 29% increased risk of subsequent cerebral palsy that was not statistically significant (95% CI -16 to +110, p=0.274). The increased risk was only significant for those with preterm birth who showed an 89% increased risk of subsequent cerebral palsy associated with a motor vehicle crash (95% CI +7 to +266, p=0.037). No significant increase was apparent for those with a term delivery (95% CI -62 to +79, p=0.510). A propensity score-matched analysis of preterm births (n=4384) yielded a 138% increased relative risk of cerebral palsy associated with a motor vehicle crash (95% CI +27 to +349, p=0.007), equal to an absolute increase of about 10.9 additional cases per 1000 newborns (18.2 vs 7.3, p=0.010). Motor vehicle crashes during pregnancy may be associated with an increased risk of cerebral palsy among the subgroup of cases with preterm birth. The increase highlights a specific role for traffic safety advice in prenatal care.

Pregnancy causes diverse physiologic and lifestyle changes that may contribute to increased driving and driving error. We compared the risk of a serious motor vehicle crash during the second trimester to the baseline risk before pregnancy. We conducted a population-based self-matched longitudinal cohort analysis of women who gave birth in Ontario between April 1, 2006, and March 31, 2011. We excluded women less than age 18 years, those living outside Ontario, those who lacked a valid health card identifier under universal insurance, and those under the care of a midwife. The primary outcome was a motor vehicle crash resulting in a visit to an emergency department. A total of 507 262 women gave birth during the study period. These women accounted for 6922 motor vehicle crashes as drivers during the 3-year baseline interval (177 per mo) and 757 motor vehicle crashes as drivers during the second trimester (252 per mo), equivalent to a 42% relative increase (95% confidence interval 32%–53%; p < 0.001). The increased risk extended to diverse populations, varied obstetrical cases and different crash characteristics. The increased risk was largest in the early second trimester and compensated for by the third trimester. No similar increase was observed in crashes as passengers or pedestrians, cases of intentional injury or inadvertent falls, or self-reported risky behaviours. Pregnancy is associated with a substantial risk of a serious motor vehicle crash during the second trimester. This risk merits attention for prenatal care.