Outcomes associated with planned place of birth among low-risk pregnancies in Ontario, Canada (2012-2021): A protocol for a population-based propensity score weighted cohort study.

BACKGROUND: Evidence suggests that for low-risk pregnancies, planned home births attended by a skilled health professional in settings where such services are well integrated are associated with lower risk of intrapartum interventions and no increase in adverse health outcomes. Monitoring and updating evidence on the safety of planned home births is necessary to inform ongoing clinical and policy decisions. METHODS: This protocol describes a population-based retrospective cohort study which aims to compare risk of (a) neonatal morbidity and mortality, and (b) maternal outcomes and birth interventions, between people at low obstetrical risk with a planned home birth with a midwife, a planned a hospital birth with a midwife, or a planned hospital birth with a physician. The study population will include Ontario residents who gave birth in Ontario, Canada between April 1, 2012, and March 31, 2021. We will use data collected prospectively in a provincial perinatal data registry. The primary outcome will be severe neonatal morbidity or mortality, a composite binary outcome that includes one or more of the following conditions: stillbirth during the intrapartum period, neonatal death (death of a liveborn infant in the first 28 completed days of life), five-minute Apgar score <4, or infant resuscitation requiring cardiac compressions. We will conduct a stratified analysis with three strata: nulliparous, parous-no previous caesarean birth, and parous-prior caesarean birth. To reduce the impact of selection bias in estimating the effect of planned place of birth on neonatal and maternal outcomes, we will use propensity score (PS) overlap weighting (OW) and modified Poisson regression to conduct multivariate analyses.

Maternal outcomes and birth interventions among women who begin labour intending to give birth at home compared to women of low obstetrical risk who intend to give birth in hospital: A systematic review and meta-analyses.

BACKGROUND: We previously concluded that risk of stillbirth, neonatal mortality or morbidity is not different whether birth is intended at home or hospital. Here, we compare the occurrence of birth interventions and maternal outcomes among low-risk women who begin labour intending to birth at home compared to women intending to birth in hospital. METHODS: We used our registered protocol (PROSPERO, http://www.crd.york.ac.uk, No.CRD42013004046) and searched five databases from 1990-2018. Using R, we obtained pooled estimates of effect (accounting for study design, study setting and parity). FINDINGS: 16 studies provided data from ~500,000 intended home births for the meta-analyses. There were no reported maternal deaths. When controlling for parity in well-integrated settings we found women intending to give birth at home compared to hospital were less likely to experience: caesarean section OR 0.58(0.44,0.77); operative vaginal birth OR 0.42(0.23,0.76); epidural analgesia OR 0.30(0.24,0.38); episiotomy OR 0.45(0.28,0.73); 3rd or 4th degree tear OR 0.57(0.43,0.75); oxytocin augmentation OR 0.37(0.26,0.51) and maternal infection OR 0.23(0.15,0.35). Pooled results for postpartum haemorrhage showed women intending home births were either less likely or did not differ from those intending hospital birth [OR 0.66(0.54,0.80) and RR 1.30(0.79,2.13) from 2 studies that could not be pooled with the others]. Similar results were found when data were stratified by parity and by degree of integration into health systems. INTERPRETATION: Among low-risk women, those intending to birth at home experienced fewer birth interventions and untoward maternal outcomes. These findings along with earlier work reporting neonatal outcomes inform families, health care providers and policy makers around the safety of intended home births. FUNDING: Partial funding: Association of Ontario Midwives open peer reviewed grant.

Perinatal or neonatal mortality among women who intend at the onset of labour to give birth at home compared to women of low obstetrical risk who intend to give birth in hospital: A systematic review and meta-analyses.

BACKGROUND: More women are choosing to birth at home in well-resourced countries. Concerns persist that out-of-hospital birth contributes to higher perinatal and neonatal mortality. This systematic review and meta-analyses determines if risk of fetal or neonatal loss differs among low-risk women who begin labour intending to give birth at home compared to low-risk women intending to give birth in hospital. METHODS: In April 2018 we searched five databases from 1990 onward and used R to obtain pooled estimates of effect. We stratified by study design, study settings and parity. The primary outcome is any perinatal or neonatal death after the onset of labour. The study protocol is peer-reviewed, published and registered (PROSPERO No.CRD42013004046). FINDINGS: We identified 14 studies eligible for meta-analysis including ~ 500,000 intended home births. Among nulliparous women intending a home birth in settings where midwives attending home birth are well-integrated in health services, the odds ratio (OR) of perinatal or neonatal mortality compared to those intending hospital birth was 1.07 (95% Confidence Interval [CI], 0.70 to 1.65); and in less integrated settings 3.17 (95% CI, 0.73 to 13.76). Among multiparous women intending a home birth in well-integrated settings, the estimated OR compared to those intending a hospital birth was 1.08 (95% CI, 0.84 to 1.38); and in less integrated settings was 1.58 (95% CI, 0.50 to 5.03). INTERPRETATION: The risk of perinatal or neonatal mortality was not different when birth was intended at home or in hospital. FUNDING: Partial funding: Association of Ontario Midwives open peer reviewed grant. RESEARCH IN CONTEXT: Evidence before this study Although there is increasing acceptance for intended home birth as a choice for birthing women, controversy about its safety persists. The varying responses of obstetrical societies to intended home birth provide evidence of contrasting views. A Cochrane review of randomised controlled trials addressing this topic included one small trial and noted that in the absence of adequately sized randomised controlled trials on the topic of intended home compared to intended hospital birth, a peer reviewed protocol be published to guide a systematic review and meta-analysis including observational studies. Reviews to date have been limited by design or methodological issues and none has used a protocol published a priori.Added value of this study Individual studies are underpowered to detect small but potentially important differences in rare outcomes. This study uses a published peer-reviewed protocol and is the largest and most comprehensive meta-analysis comparing outcomes of intended home and hospital birth. We take study design, parity and jurisdictional support for home birth into account. Our study provides much needed information to policy makers, care providers and women and families when planning for birth.Implications of all the available evidence Women who are low risk and who intend to give birth at home do not appear to have a different risk of fetal or neonatal loss compared to a population of similarly low risk women intending to give birth in hospital.

Outcomes associated with planned place of birth among women with low-risk pregnancies.

BACKGROUND: Previous studies have shown that planned home birth is associated with a decreased likelihood of intrapartum intervention with no difference in neonatal outcomes compared with planned hospital birth. The purpose of our study was to evaluate different birth settings by comparing neonatal mortality, morbidity and rates of birth interventions between planned home and planned hospital births in Ontario, Canada. METHODS: We used a provincial database of all midwifery-booked pregnancies between 2006 and 2009 to compare women who planned home birth at the onset of labour to a matched cohort of women with low-risk pregnancies who had planned hospital births attended by midwives. We conducted subgroup analyses by parity. Our primary outcome was stillbirth, neonatal death (< 28 d) or serious morbidity (Apgar score < 4 at 5 min or resuscitation with positive pressure ventilation and cardiac compressions). RESULTS: We compared 11 493 planned home births and 11 493 planned hospital births. The risk of our primary outcome did not differ significantly by planned place of birth (relative risk [RR] 1.03, 95% confidence interval [CI] 0.68-1.55). These findings held true for both nulliparous (RR 1.04, 95% CI 0.62-1.73) and multiparous women (RR 1.00, 95% CI 0.49-2.05). All intrapartum interventions were lower among planned home births. INTERPRETATION: Compared with planned hospital birth, planned home birth attended by midwives in a jurisdiction where home birth is well-integrated into the health care system was not associated with a difference in serious adverse neonatal outcomes but was associated with fewer intrapartum interventions.

Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes.

BACKGROUND: Clustering of outcomes at centers involved in multicenter trials is a type of center effect. The Consolidated Standards of Reporting Trials Statement recommends that multicenter randomized controlled trials (RCTs) should account for center effects in their analysis, however most do not. The Early External Cephalic Version (EECV) trials published in 2003 and 2011 stratified by center at randomization, but did not account for center in the analyses, and due to the nature of the intervention and number of centers, may have been prone to center effects. Using data from the EECV trials, we undertook an empirical study to compare various statistical approaches to account for center effect while estimating the impact of external cephalic version timing (early or delayed) on the outcomes of cesarean section, preterm birth, and non-cephalic presentation at the time of birth. METHODS: The data from the EECV pilot trial and the EECV2 trial were merged into one dataset. Fisher's exact method was used to test the overall effect of external cephalic version timing unadjusted for center effects. Seven statistical models that accounted for center effects were applied to the data. The models included: i) the Mantel-Haenszel test, ii) logistic regression with fixed center effect and fixed treatment effect, iii) center-size weighted and iv) un-weighted logistic regression with fixed center effect and fixed treatment-by-center interaction, iv) logistic regression with random center effect and fixed treatment effect, v) logistic regression with random center effect and random treatment-by-center interaction, and vi) generalized estimating equations. RESULTS: For each of the three outcomes of interest approaches to account for center effect did not alter the overall findings of the trial. The results were similar for the majority of the methods used to adjust for center, illustrating the robustness of the findings. CONCLUSIONS: Despite literature that suggests center effect can change the estimate of effect in multicenter trials, this empirical study does not show a difference in the outcomes of the EECV trials when accounting for center effect. TRIAL REGISTRATION: The EECV2 trial was registered on 30 July 30 2005 with Current Controlled Trials: ISRCTN 56498577.

Protocol: systematic review and meta-analyses of birth outcomes for women who intend at the onset of labour to give birth at home compared to women of low obstetrical risk who intend to give birth in hospital.

BACKGROUND: There has been a renewed interest in the place of birth, including intended home birth, for low risk women. In the absence of adequately-sized randomised controlled trials, a recent Cochrane review recommended that a systematic review and meta-analysis, including observational studies, be undertaken to inform this topic. The objective of this review is to determine if women intending at the onset of labour to give birth at home are more or less likely to experience a foetal or neonatal loss compared to a cohort of women who are comparable to the home birth cohort on the absence of risk factors but who intend to give birth in a hospital setting. METHODS: We will search using Embase, MEDLINE, CINAHL, AMED and the Cochrane Library to find studies published since 1990 that compare foetal, neonatal and maternal outcomes for women who intended at the onset of labour to give birth at home to a comparison cohort of low risk women who intended at the onset of labour to give birth in hospital. We will obtain pooled estimates of effect using Review Manager. Because of the likelihood of differences in outcomes in settings where home birth is integrated into the health care system, we will stratify our results according to jurisdictions that have a health care system that integrates home birth and those where home birth is provided outside the usual health care system. Since parity is known to be associated with birth outcomes, only studies that take parity into account will be included in the meta-analyses. We will provide results by parity to the extent possible. SYSTEMATIC REVIEW REGISTRATION: This protocol was registered with PROSPERO at http://www.crd.york.ac.uk/Prospero/ (Registration number: CRD42013004046).

Women's experiences of participating in the early external cephalic version 2 trial.

BACKGROUND: The international, multicenter External Cephalic Version 2 (ECV2) Trial compared early external cephalic version at 34(0/7) to 35(6/7) weeks with that at greater than 37 weeks. A total of 1,543 women were randomized from 68 centers in 21 countries. The goal of this component of the trial was to understand women's views about participation in a research trial and timing of external cephalic version. METHODS: A postpartum questionnaire was completed containing a 5-point Likert scale examining contact and availability of staff, choice of timing of external cephalic version, preference of randomization, convenience of participating, and overall satisfaction. Participants also completed two open-ended questions related to timing of external cephalic version and satisfaction with the trial. Descriptive statistics and content analysis were used to analyze data. RESULTS: A total of 1,458 women completed the questionnaire, of whom 86 percent said "yes"-they would participate in the trial again. Themes influencing decisions about participating were perceptions of the external cephalic version experience, preferred mode of delivery, preferred timing of external cephalic version, and perceptions of the effectiveness of external cephalic version and of the trial environment. Many participants preferred the early timing of the procedure offered through the trial because of perceived advantages of a smaller baby being easier to turn and the opportunity for repeat procedures. CONCLUSIONS: Women were positive about their participation in the trial. Early external cephalic version was preferred over the traditional timing as it was perceived to afford both physiologic and practical advantages.

Pregnancy outcomes in women with chronic kidney disease: a systematic review.

BACKGROUND AND OBJECTIVES: Pregnant women with chronic kidney disease (CKD) are at risk of adverse maternal and fetal outcomes. We conducted a systematic review of observational studies that described this risk. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We searched several databases from their date of inception through June 2010 for eligible articles published in any language. We included any study that reported maternal or fetal outcomes in at least five pregnant women in each group with or without CKD. We excluded pregnant women with a history of transplantation or maintenance dialysis. RESULTS: We identified 13 studies. Adverse maternal events including gestational hypertension, pre-eclampsia, eclampsia, and maternal mortality were reported in 12 studies. There were 312 adverse maternal events among 2682 pregnancies in women with CKD (weighted average of 11.5%) compared with 500 events in 26,149 pregnancies in normal healthy women (weighted average of 2%). One or more adverse fetal outcomes such as premature births, intrauterine growth restriction, small for gestational age, neonatal mortality, stillbirths, and low birth weight were reported in nine of the included studies. Overall, the risk of developing an adverse fetal outcome was at least two times higher among women with CKD compared with those without. CONCLUSIONS: This review summarizes current available evidence to guide physicians in their decision-making, advice, and care for pregnant women with CKD. Additional studies are needed to better characterize the risks.

Outcomes associated with planned home and planned hospital births in low-risk women attended by midwives in Ontario, Canada, 2003-2006: a retrospective cohort study.

BACKGROUND: Midwives in Ontario, Canada, provide care in the home and hospital and are required to submit data for all births to the Ontario Ministry of Health database. The purpose of this study was to compare maternal and perinatal/neonatal mortality and morbidity and intrapartum intervention rates for women attended by Ontario midwives who planned a home birth compared with similar low-risk women who planned a hospital birth between 2003 and 2006. METHODS: The database provided outcomes for all women planning a home birth at the onset of labor (n = 6,692) and for a cohort, stratified by parity, of similar low-risk women planning a hospital birth. RESULTS: The rate of perinatal and neonatal mortality was very low (1/1,000) for both groups, and no difference was shown between groups in perinatal and neonatal mortality or serious morbidity (2.4% vs 2.8%; relative risk [RR], 95% confidence intervals [CI]: 0.84 [0.68-1.03]). No maternal deaths were reported. All measures of serious maternal morbidity were lower in the planned home birth group as were rates for all interventions including cesarean section (5.2% vs 8.1%; RR [95% CI]: 0.64 [0.56, 0.73]). Nulliparas were less likely to deliver at home, and had higher rates of ambulance transport from home to hospital than multiparas planning home birth and had rates of intervention and outcomes similar to, or lower than, nulliparas planning hospital births. CONCLUSIONS: Midwives who were integrated into the health care system with good access to emergency services, consultation, and transfer of care provided care resulting in favorable outcomes for women planning both home or hospital births.

Smoking in Ontario schools: does policy make a difference?

OBJECTIVE: Studies in other countries have shown that school tobacco control policy has potential to prevent smoking uptake in adolescents. Since no Canadian research has studied this association, we assessed the statistical link between school tobacco policy and smoking status in Ontario elementary and secondary schools. METHODS: We conducted secondary analysis of data collected using the School Smoking Profile, a cross-sectional, self-report questionnaire. School policy variables were formed from five survey items concerning students' perceptions of school tobacco control policy. Smoking status was determined through self-report measures which had been validated by carbon monoxide testing. Logistic regression models used school policy variables to explain smoking status in elementary and secondary schools, controlling for school location, school size, and student's grade level. RESULTS: The smoking policy variables, rules and enforcement, explained smoking status after controlling for other variables. In elementary schools, perceptions of stronger enforcement reduced the odds of being a smoker (OR = 0.39, CI99 = 0.34-0.44). In secondary schools, enforcement lost its protective effect (OR = 1.05, CI99 = 1.00-1.10). In addition, student perceptions that rules were strong were indicative of increased smoking in secondary schools (OR = 1.32, CI99 = 1.27-1.37). DISCUSSION: Strong enforcement of school tobacco control policy appears to be effective in elementary schools but is not as helpful in secondary schools. Secondary school policymakers should consider modifying their sanctions to avoid alienating smokers.