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BACKGROUND: An original validated risk prediction model with good discriminatory prognostic performance for predicting gestational diabetes (GDM) diagnosis, has been updated for recent international association of diabetes in pregnancy study group (IADPSG) diagnostic criteria. However, the updated model is yet to be externally validated on an international dataset. AIMS: To perform an external validation of the updated risk prediction model to evaluate model indices such as discrimination and calibration based on data from the International Weight Management in Pregnancy (i-WIP) Collaborative Group. MATERIALS AND METHODS: The i -WIP dataset was used to validate the GDM prediction tool across discrimination and model calibration. RESULTS: Overall 7689 individual patient data were included, with 17.4 % with GDM, however only 113 cases were available using IADPSG (International Association of Diabetes and Pregnancy Groups) criteria for 75 g OGTT glucose load and ACOG (American College of Obstetricians and Gynecologists) for 100 g glucose load and having the routine clinical risk factor data. The GDM model was moderately discriminatory (Area Under the Curve (AUC) of 0.67; 95 % CI 0.59 to 0.75), Sensitivity 81.0 % (95 % CI 66.7 % to 90.9 %), specificity 53 % (40.3 % to 65.4 %). The GDM score showed reasonable calibration for predicting GDM (slope = 0.84, CITL = 0.77). Imputation for missing data increased the sample to n = 253, and vastly improved the discrimination and calibration of the model to AUC = 78 (95 % CI 72 to 85), sensitivity (81 %, 95 % CI 66.7 % to 90.9 %) and specificity (75 %, 95 % CI 68.8 % to 81 %). CONCLUSION: The updated GDM model showed promising discrimination in predicting GDM in an international population sourced from RCT individual patient data. External validations are essential in order for the risk prediction area to advance, and we demonstrate the utility of using existing RCT data from different global settings. Despite limitations associated with harmonising the data to the variable types in the model, the validation model indices were reasonable, supporting generalizability across continents and populations.
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OBJECTIVE: To identify current practices in the management of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies. DESIGN: Cross-sectional survey. SETTING: International. POPULATION: Clinicians involved in the management of MCDA twin pregnancies with sFGR. METHODS: A structured, self-administered survey. MAIN OUTCOME MEASURES: Clinical practices and attitudes to diagnostic criteria and management strategies. RESULTS: Overall, 62.8% (113/180) of clinicians completed the survey; of which, 66.4% (75/113) of the respondents reported that they would use an estimated fetal weight (EFW) of <10th centile for the smaller twin and an inter-twin EFW discordance of >25% for the diagnosis of sFGR. For early-onset type I sFGR, 79.8% (75/94) of respondents expressed that expectant management would be their routine practice. On the other hand, for early-onset type II and type III sFGR, 19.3% (17/88) and 35.7% (30/84) of respondents would manage these pregnancies expectantly, whereas 71.6% (63/88) and 57.1% (48/84) would refer these pregnancies to a fetal intervention centre or would offer fetal intervention for type II and type III cases, respectively. Moreover, 39.0% (16/41) of the respondents would consider fetoscopic laser surgery (FLS) for early-onset type I sFGR, whereas 41.5% (17/41) would offer either FLS or selective feticide, and 12.2% (5/41) would exclusively offer selective feticide. For early-onset type II and type III sFGR cases, 25.9% (21/81) and 31.4% (22/70) would exclusively offer FLS, respectively, whereas 33.3% (27/81) and 32.9% (23/70) would exclusively offer selective feticide. CONCLUSIONS: There is significant variation in clinician practices and attitudes towards the management of early-onset sFGR in MCDA twin pregnancies, especially for type II and type III cases, highlighting the need for high-level evidence to guide management.
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BACKGROUND: Time-lapse imaging systems for embryo incubation and selection might improve outcomes of in-vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI) treatment due to undisturbed embryo culture conditions, improved embryo selection, or both. However, the benefit remains uncertain. We aimed to evaluate the effectiveness of time-lapse imaging systems providing undisturbed culture and embryo selection, and time-lapse imaging systems providing only undisturbed culture, and compared each with standard care without time-lapse imaging. METHODS: We conducted a multicentre, three-parallel-group, double-blind, randomised controlled trial in participants undergoing IVF or ICSI at seven IVF centres in the UK and Hong Kong. Embryologists randomly assigned participants using a web-based system, stratified by clinic in a 1:1:1 ratio to the time-lapse imaging system for undisturbed culture and embryo selection (time-lapse imaging group), time-lapse imaging system for undisturbed culture alone (undisturbed culture group), and standard care without time-lapse imaging (control group). Women were required to be aged 18-42 years and men (ie, their partners) 18 years or older. Couples had to be receiving their first, second, or third IVF or ICSI treatment and could not participate if using donor gametes. Participants and trial staff were masked to group assignment, embryologists were not. The primary outcome was live birth. We performed analyses using the intention-to-treat principle and reported the main analysis in participants with primary outcome data available (full analysis set). The trial is registered on the International Trials Registry (ISRCTN17792989) and is now closed. FINDINGS: 1575 participants were randomly assigned to treatment groups (525 participants per group) between June 21, 2018, and Sept 30, 2022. The live birth rates were 33·7% (175/520) in the time-lapse imaging group, 36·6% (189/516) in the undisturbed culture group, and 33·0% (172/522) in the standard care group. The adjusted odds ratio was 1·04 (97·5% CI 0·73 to 1·47) for time-lapse imaging arm versus control and 1·20 (0·85 to 1·70) for undisturbed culture versus control. The risk reduction for the absolute difference was 0·7 percentage points (97·5% CI -5·85 to 7·25) between the time-lapse imaging and standard care groups and 3·6 percentage points (-3·02 to 10·22) between the undisturbed culture and standard care groups. 79 serious adverse events unrelated to the trial were reported (n=28 in time-lapse imaging, n=27 in undisturbed culture, and n=24 in standard care). INTERPRETATION: In women undergoing IVF or ICSI treatment, the use of time-lapse imaging systems for embryo culture and selection does not significantly increase the odds of live birth compared with standard care without time-lapse imaging. FUNDING: Barts Charity, Pharmasure Pharmaceuticals, Hong Kong OG Trust Fund, Hong Kong Health and Medical Research Fund, Hong Kong Matching Fund.
Subject(s)
Embryo Culture Techniques , Fertilization in Vitro , Sperm Injections, Intracytoplasmic , Time-Lapse Imaging , Humans , Female , Time-Lapse Imaging/methods , Double-Blind Method , Fertilization in Vitro/methods , Adult , Pregnancy , Embryo Culture Techniques/methods , Sperm Injections, Intracytoplasmic/methods , Pregnancy Rate , Embryo Transfer/methods , Treatment OutcomeABSTRACT
Background: Caesarean section (CS) is the most performed major surgery worldwide. Surgical techniques used for CS vary widely and there is no internationally accepted standardization. We conducted an overview of systematic reviews (SR) of randomized controlled trials (RCT) to summarize the evidence on surgical techniques or procedures related to CS. Methods: Searches were conducted from database inception to 31 January 2024 in Cochrane Database of Systematic Reviews, PubMed, EMBASE, Lilacs and CINAHL without date or language restrictions. AMSTAR 2 and GRADE were used to assess the methodological quality of the SRs and the certainty of evidence at outcome level, respectively. We classified each procedure-outcome pair into one of eight categories according to effect estimates and certainty of evidence. The overview was registered at PROSPERO (CRD 42023208306). Findings: The analysis included 38 SRs (16 Cochrane and 22 non-Cochrane) published between 2004-2024 involving 628 RCT with a total of 190,349 participants. Most reviews were of low or critically low quality (AMSTAR 2). The SRs presented 345 procedure-outcome comparisons (237 procedure versus procedure, 108 procedure versus no treatment/placebo). There was insufficient or inconclusive evidence for 256 comparisons, clear evidence of benefit for 40, possible benefit for 17, no difference of effect for 13, clear evidence of harm for 14, and possible harm for 5. We found no SRs for 7 pre-defined procedures. Skin cleansing with chlorhexidine, Joel-Cohen-based abdominal incision, uterine incision with blunt dissection and cephalad-caudal expansion, cord traction for placental extraction, manual cervical dilatation in pre-labour CS, changing gloves, chromic catgut suture for uterine closure, non-closure of the peritoneum, closure of subcutaneous tissue, and negative pressure wound therapy are procedures associated with benefits for relevant outcomes. Interpretation: Current evidence suggests that several CS surgical procedures improve outcomes but also reveals a lack of or inconclusive evidence for many commonly used procedures. There is an urgent need for evidence-based guidelines standardizing techniques for CS, and trials to fill existing knowledge gaps. Funding: UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO).
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OBJECTIVE: To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Major databases between December 2019 and January 2023. STUDY SELECTION: Nine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included. QUALITY ASSESSMENT, DATA EXTRACTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs. RESULTS: Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women). CONCLUSION: COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women. PROSPERO REGISTRATION NUMBER: CRD42020178076.
Subject(s)
COVID-19 Vaccines , COVID-19 , Pregnancy Complications, Infectious , Pregnancy Outcome , SARS-CoV-2 , Humans , Pregnancy , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Female , Pregnancy Complications, Infectious/prevention & control , Infant, NewbornABSTRACT
Maternal outcomes throughout pregnancy, childbirth, and the postnatal period are influenced by interlinked and interdependent vulnerabilities. A comprehensive understanding of how various threats and barriers affect maternal and perinatal health is critical to plan, evaluate and improve maternal health programmes. This paper builds on the introductory paper of the Series on the determinants of maternal health by assessing vulnerabilities during pregnancy, childbirth, and the postnatal period. We synthesise and present the concept of vulnerability in pregnancy and childbirth, and map vulnerability attributes and their dynamic influence on maternal outcomes in early and late pregnancy and during childbirth and the postnatal period, with a particular focus on low-income and middle-income countries (LMICs). We summarise existing literature and present the evidence on the effects of various reparative strategies to improve pregnancy and childbirth outcomes. Lastly, we discuss the implications of the identified vulnerability attributes and reparative strategies for the efforts of policymakers, healthcare professionals, and researchers working towards improving outcomes for women and birthing people in LMICs.
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BACKGROUND: Despite many systematic reviews and meta-analyses examining the associations of pregnancy complications with risk of type 2 diabetes mellitus (T2DM) and hypertension, previous umbrella reviews have only examined a single pregnancy complication. Here we have synthesised evidence from systematic reviews and meta-analyses on the associations of a wide range of pregnancy-related complications with risk of developing T2DM and hypertension. METHODS: Medline, Embase and Cochrane Database of Systematic Reviews were searched from inception until 26 September 2022 for systematic reviews and meta-analysis examining the association between pregnancy complications and risk of T2DM and hypertension. Screening of articles, data extraction and quality appraisal (AMSTAR2) were conducted independently by two reviewers using Covidence software. Data were extracted for studies that examined the risk of T2DM and hypertension in pregnant women with the pregnancy complication compared to pregnant women without the pregnancy complication. Summary estimates of each review were presented using tables, forest plots and narrative synthesis and reported following Preferred Reporting Items for Overviews of Reviews (PRIOR) guidelines. RESULTS: Ten systematic reviews were included. Two pregnancy complications were identified. Gestational diabetes mellitus (GDM): One review showed GDM was associated with a 10-fold higher risk of T2DM at least 1 year after pregnancy (relative risk (RR) 9.51 (95% confidence interval (CI) 7.14 to 12.67) and although the association differed by ethnicity (white: RR 16.28 (95% CI 15.01 to 17.66), non-white: RR 10.38 (95% CI 4.61 to 23.39), mixed: RR 8.31 (95% CI 5.44 to 12.69)), the between subgroups difference were not statistically significant at 5% significance level. Another review showed GDM was associated with higher mean blood pressure at least 3 months postpartum (mean difference in systolic blood pressure: 2.57 (95% CI 1.74 to 3.40) mmHg and mean difference in diastolic blood pressure: 1.89 (95% CI 1.32 to 2.46) mmHg). Hypertensive disorders of pregnancy (HDP): Three reviews showed women with a history of HDP were 3 to 6 times more likely to develop hypertension at least 6 weeks after pregnancy compared to women without HDP (meta-analysis with largest number of studies: odds ratio (OR) 4.33 (3.51 to 5.33)) and one review reported a higher rate of T2DM after HDP (hazard ratio (HR) 2.24 (1.95 to 2.58)) at least a year after pregnancy. One of the three reviews and five other reviews reported women with a history of preeclampsia were 3 to 7 times more likely to develop hypertension at least 6 weeks postpartum (meta-analysis with the largest number of studies: OR 3.90 (3.16 to 4.82) with one of these reviews reporting the association was greatest in women from Asia (Asia: OR 7.54 (95% CI 2.49 to 22.81), Europe: OR 2.19 (95% CI 0.30 to 16.02), North and South America: OR 3.32 (95% CI 1.26 to 8.74)). CONCLUSIONS: GDM and HDP are associated with a greater risk of developing T2DM and hypertension. Common confounders adjusted for across the included studies in the reviews were maternal age, body mass index (BMI), socioeconomic status, smoking status, pre-pregnancy and current BMI, parity, family history of T2DM or cardiovascular disease, ethnicity, and time of delivery. Further research is needed to evaluate the value of embedding these pregnancy complications as part of assessment for future risk of T2DM and chronic hypertension.
Subject(s)
Diabetes Mellitus, Type 2 , Diabetes, Gestational , Hypertension , Pre-Eclampsia , Female , Humans , Pregnancy , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Diabetes, Gestational/prevention & control , Hypertension/complications , Hypertension/epidemiology , Parity , Systematic Reviews as Topic , Meta-Analysis as TopicABSTRACT
BACKGROUND: ART is associated with higher rates of twin pregnancies than singleton pregnancies. Whether twin pregnancies conceived following ART have additional maternal and neonatal complications compared with non-ART twin pregnancies is not known. OBJECTIVE AND RATIONALE: The objective was to quantify the risk of adverse maternal and perinatal outcomes among twin pregnancies conceived following ART compared with non-ART and natural conception. Existing reviews vary in the reported outcomes, with many studies including triplet pregnancies in the study population. Therefore, we aimed to perform an up-to-date review with an in-depth analysis of maternal and perinatal outcomes limited to twin pregnancies. SEARCH METHODS: We searched electronic databases MEDLINE and EMBASE from January 1990 to May 2023 without language restrictions. All cohort studies reporting maternal and perinatal outcomes following ART compared with non-ART twin pregnancies and natural conception were included. Case-control studies, case reports, case series, animal studies, and in vitro studies were excluded. The Newcastle-Ottawa Scale was used to assess the methodological quality of the studies. Using random-effects meta-analysis, the estimates were pooled and the findings were reported as odds ratios (OR) with 95% CI. OUTCOMES: We included 111 studies (802 462 pregnancies). Twin pregnancies conceived following ART were at higher risk of preterm birth at <34 weeks (OR 1.33, 95% CI 1.14-1.56, 29 studies, I2 = 73%), <37 weeks (OR 1.26, 95% CI 1.19-1.33, 70 studies, I2 = 76%), hypertensive disorders in pregnancy (OR 1.29, 95% CI 1.14-1.46, 59 studies, I2 = 87%), gestational diabetes mellitus (OR 1.61, 95% CI 1.48-1.75, 51 studies, I2 = 65%), and caesarean delivery (OR 1.80, 95% CI 1.65-1.97, 70 studies, I2 = 89%) compared with non-ART twins. The risks for the above maternal outcomes were also increased in the ART group compared with natural conception. Of the perinatal outcomes, ART twins were at significantly increased risk of congenital malformations (OR 1.17, 95% CI 1.05-1.30, 39 studies, I2 = 59%), birthweight discordance (>25% (OR 1.31, 95% CI 1.05-1.63, 7 studies, I2 = 0%)), respiratory distress syndrome (OR 1.32, 95% CI 1.09-1.60, 16 studies, I2 = 61%), and neonatal intensive care unit admission (OR 1.24, 95% CI 1.14-1.35, 32 studies, I2 = 87%) compared with non-ART twins. When comparing ART with natural conception, the risk of respiratory distress syndrome, intensive care admissions, and birthweight discordance >25% was higher among the ART group. Perinatal complications, such as stillbirth (OR 0.83, 95% CI 0.70-0.99, 33 studies, I2 = 49%), small for gestational age <10th centile (OR 0.90, 95% CI 0.85-0.95, 26 studies, I2 = 36%), and twin-twin transfusion syndrome (OR 0.45, 95% CI 0.25-0.82, 9 studies, I2 = 25%), were reduced in twin pregnancies conceived with ART versus those without ART. The above perinatal complications were also fewer amongst the ART group than natural conception. WIDER IMPLICATIONS: ART twin pregnancies are associated with higher maternal complications than non-ART pregnancies and natural conception, with varied perinatal outcomes. Women seeking ART should be counselled about the increased risks of ART twin pregnancies and should be closely monitored in pregnancy for complications. We recommend exercising caution when interpreting the study findings owing to the study's limitations.
Subject(s)
Pregnancy Outcome , Pregnancy, Twin , Reproductive Techniques, Assisted , Humans , Pregnancy , Female , Reproductive Techniques, Assisted/adverse effects , Pregnancy Outcome/epidemiology , Infant, Newborn , Pregnancy Complications/epidemiology , Premature Birth/epidemiology , Premature Birth/etiologyABSTRACT
CONTEXT: There is limited knowledge about the disparities between the sexes in obesity prevalence and associated cardiovascular complications in low- and middle-income countries (LMICs). OBJECTIVE: We undertook a systematic review and meta-analysis to assess sex-specific disparities in the prevalence of obesity and cardiometabolic diseases in LMICs, the burden in women, and variations by region, country's income status, setting, and time. METHODS: We searched major databases from inception to March 2023. Two independent reviewers selected the studies, assessed their quality, and extracted data. We used DerSimonian and Laird random-effects models to obtain pooled estimates of odds ratios and 95% CI for the association between sex and obesity and cardiometabolic diseases, and multilevel random-effects logistic regression models to estimate the prevalence of relevant outcomes (PROSPERO CRD42019132609). RESULTS: We included 345 studies (3 916 276 individuals). The odds of obesity were 2.72-fold higher in women than men (OR 2.72; 95% CI, 2.54-2.91). The sex-specific disparities varied by region, with the greatest disparities in Sub-Saharan Africa (OR 3.91; 95% CI, 3.49-4.39). Among women in LMICs, 23% (95% CI, 21%-25%) had obesity, 27% (95% CI, 24%-29%) had hypertension, and 7% (95% CI, 6%-9%) had type 2 diabetes. The prevalence of obesity and type 2 diabetes in women varied by region, country's income, and setting, with the highest prevalence in the Middle East and North Africa, upper-middle-income countries and urban settings. The odds of hypertension (OR 2.41; 95% CI, 1.89-3.08) and type 2 diabetes (OR 2.65; 95% CI, 1.76-3.98) were doubled in women with vs without obesity. CONCLUSION: There is an urgent need for a women-centred and region-stratified approach to tackle obesity awareness, treatment, and prevention in women in LMICs.
Subject(s)
Diabetes Mellitus, Type 2 , Hypertension , Male , Humans , Female , Diabetes Mellitus, Type 2/epidemiology , Developing Countries , Obesity/epidemiology , Hypertension/epidemiology , Income , PrevalenceABSTRACT
BACKGROUND: Findings related to the association between persistent organic pollutants (POPs) and gestational diabetes mellitus (GDM) are inconclusive. OBJECTIVES: To estimate the strength of the association between POP exposure and GDM in a systematic review with meta-analysis. SEARCH STRATEGY: MEDLINE, Scopus and Web of Science were searched until July 2023. SELECTION CRITERIA: Cohort and case-control studies analysing the association between POPs and GDM. DATA COLLECTION AND ANALYSIS: We assessed the risk of bias using the Quality in Prognosis Studies scale (QUIPS). Standardised mean differences were pooled using random-effect models. MAIN RESULTS: Sixteen articles including 12 216 participants were selected. The risk of bias was high in four articles (25%), moderate in 11 (68.75%) and low in one (6.25%). Small mean difference between GDM cases and controls was observed for PFHpA (0.26, 95% confidence interval [CI] 0.1-0.35, I2 = 0.0%), PCB180 (0.37, 95% CI 0.19-0.56; I2 = 25.3%), BDE47 (0.23, 95% CI 0.0-0.45, I2 = 0%), BDE99 (0.36, 95% CI 0.14-0.59; I2 = 0%), BDE100 (0.42, 95% CI 0.19-0.64; I2 = 0%) and HCB (0.22, 95% CI 0.01-0.42, I2 = 39.6%). No considerable difference was observed for the rest of POPs. CONCLUSION: Small mean differences between GDM cases and controls were observed for some POPs. However, evidence shows mostly moderate quality and results were heterogeneous. Improved research methodology is needed to assess POPs and GDM risk.
Subject(s)
Diabetes, Gestational , Pregnancy , Female , Humans , Diabetes, Gestational/epidemiology , Persistent Organic Pollutants , Case-Control Studies , Risk FactorsABSTRACT
Over the past three decades, substantial progress has been made in reducing maternal mortality worldwide. However, the historical focus on mortality reduction has been accompanied by comparative neglect of labour and birth complications that can emerge or persist months or years postnatally. This paper addresses these overlooked conditions, arguing that their absence from the global health agenda and national action plans has led to the misconception that they are uncommon or unimportant. The historical limitation of postnatal care services to the 6 weeks after birth is also a contributing factor. We reviewed epidemiological data on medium-term and long-term complications arising from labour and childbirth beyond 6 weeks, along with high-quality clinical guidelines for their prevention, identification, and treatment. We explore the complex interplay of human evolution, maternal physiology, and inherent predispositions that contribute to these complications. We offer actionable recommendations to change the current trajectories of these neglected conditions and help achieve the targets of Sustainable Development Goal 3. This paper is the third in a Series of four papers about maternal health in the perinatal period and beyond.
Subject(s)
Labor, Obstetric , Pregnancy , Female , Humans , Delivery, Obstetric , ParturitionABSTRACT
BACKGROUND: Pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are more likely to experience preterm birth and their neonates are more likely to be stillborn or admitted to a neonatal unit. The World Health Organization declared in May 2023 an end to the coronavirus disease 2019 (COVID-19) pandemic as a global health emergency. However, pregnant women are still becoming infected with SARS-CoV-2 and there is limited information available regarding the effect of SARS-CoV-2 infection in early pregnancy on pregnancy outcomes. OBJECTIVE AND RATIONALE: We conducted this systematic review to determine the prevalence of early pregnancy loss in women with SARS-Cov-2 infection and compare the risk to pregnant women without SARS-CoV-2 infection. SEARCH METHODS: Our systematic review is based on a prospectively registered protocol. The search of PregCov19 consortium was supplemented with an extra electronic search specifically on pregnancy loss in pregnant women infected with SARS-CoV-2 up to 10 March 2023 in PubMed, Google Scholar, and LitCovid. We included retrospective and prospective studies of pregnant women with SARS-CoV-2 infection, provided that they contained information on pregnancy losses in the first and/or second trimester. Primary outcome was miscarriage defined as a pregnancy loss before 20 weeks of gestation, however, studies that reported loss up to 22 or 24 weeks were also included. Additionally, we report on studies that defined the pregnancy loss to occur at the first and/or second trimester of pregnancy without specifying gestational age, and for second trimester miscarriage only when the study presented stillbirths and/or foetal losses separately from miscarriages. Data were stratified into first and second trimester. Secondary outcomes were ectopic pregnancy (any extra-uterine pregnancy), and termination of pregnancy. At least three researchers independently extracted the data and assessed study quality. We calculated odds ratios (OR) and risk differences (RDs) with corresponding 95% CI and pooled the data using random effects meta-analysis. To estimate risk prevalence, we performed meta-analysis on proportions. Heterogeneity was assessed by I2. OUTCOMES: We included 120 studies comprising a total of 168 444 pregnant women with SARS-CoV-2 infection; of which 18 233 women were in their first or second trimester of pregnancy. Evidence level was considered to be of low to moderate certainty, mostly owing to selection bias. We did not find evidence of an association between SARS-CoV-2 infection and miscarriage (OR 1.10, 95% CI 0.81-1.48; I2 = 0.0%; RD 0.0012, 95% CI -0.0103 to 0.0127; I2 = 0%; 9 studies, 4439 women). Miscarriage occurred in 9.9% (95% CI 6.2-14.0%; I2 = 68%; 46 studies, 1797 women) of the women with SARS CoV-2 infection in their first trimester and in 1.2% (95% CI 0.3-2.4%; I2 = 34%; 33 studies; 3159 women) in the second trimester. The proportion of ectopic pregnancies in women with SARS-CoV-2 infection was 1.4% (95% CI 0.02-4.2%; I2 = 66%; 14 studies, 950 women). Termination of pregnancy occurred in 0.6% of the women (95% CI 0.01-1.6%; I2 = 79%; 39 studies; 1166 women). WIDER IMPLICATIONS: Our study found no indication that SARS-CoV-2 infection in the first or second trimester increases the risk of miscarriages. To provide better risk estimates, well-designed studies are needed that include pregnant women with and without SARS-CoV-2 infection at conception and early pregnancy and consider the association of clinical manifestation and severity of SARS-CoV-2 infection with pregnancy loss, as well as potential confounding factors such as previous pregnancy loss. For clinical practice, pregnant women should still be advised to take precautions to avoid risk of SARS-CoV-2 exposure and receive SARS-CoV-2 vaccination.
Subject(s)
Abortion, Spontaneous , COVID-19 , Premature Birth , Female , Humans , Pregnancy , Abortion, Spontaneous/epidemiology , COVID-19/epidemiology , Premature Birth/epidemiology , PrevalenceABSTRACT
OBJECTIVES: Daily calcium supplements are recommended for pregnant women from 20 weeks' gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia. DESIGN: Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach. DATA SOURCES: MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022. ELIGIBILITY CRITERIA: We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators. RESULTS: Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium. CONCLUSION: Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions. PROSPERO REGISTRATION NUMBER: CRD42021239143.
Subject(s)
Pre-Eclampsia , Female , Pregnancy , Humans , Pre-Eclampsia/prevention & control , Calcium/therapeutic use , Dietary Supplements , Calcium, Dietary , Prenatal Care/methodsABSTRACT
Access to emergency obstetric care, including assisted vaginal birth and caesarean birth, is crucial for improving maternal and childbirth outcomes. However, although the proportion of births by caesarean section has increased during the last few decades, the use of assisted vaginal birth has declined. This is particularly the case in low- and middle-income countries, despite an assisted vaginal birth often being less risky than caesarean birth. We therefore conducted a three-step process to identify a research agenda necessary to increase the use of, or reintroduce, assisted vaginal birth: after conducting an evidence synthesis, which informed a consultation with technical experts who proposed an initial research agenda, we sought and incorporated the views of women's representatives of this agenda. This process has allowed us to identify a comprehensive research agenda, with topics categorized as: (i) the need to understand women's perceptions of assisted vaginal birth, and provide appropriate and reliable information; (ii) the importance of training health-care providers in clinical skills but also in respectful care, effective communication, shared decision-making and informed consent; and (iii) the barriers to and facilitators of implementation and sustainability. From women's feedback, we learned of the urgent need to recognize labour, childbirth and postpartum experiences as inherently physiological and dignified human processes, in which interventions should only be implemented if necessary. The promotion and/or reintroduction of assisted vaginal birth in low-resource settings requires governments, policy-makers and hospital administrators to support skilled health-care providers who can, in turn, respectfully support women in labour and childbirth.
L'accès aux soins obstétriques d'urgence, y compris l'accouchement vaginal assisté et la césarienne, est essentiel pour améliorer les effets de la maternité et de l'accouchement. Toutefois, bien que la proportion de césariennes ait augmenté ces dernières décennies, le recours à l'accouchement vaginal assisté a diminué. C'est particulièrement le cas dans les pays à revenu faible ou intermédiaire, bien que l'accouchement vaginal assisté soit souvent moins risqué qu'une césarienne. Nous avons donc mené un processus en trois étapes afin d'imaginer un programme de recherche qui permettrait d'augmenter le recours à l'accouchement vaginal assisté ou de le réintroduire. Après avoir réalisé une synthèse des données probantes, qui a servi de base à une consultation avec des experts techniques qui ont proposé un programme de recherche initial, nous avons sollicité et incorporé les avis des représentantes des femmes pour ce programme. Ce processus nous a permis d'imaginer un programme de recherche complet, avec des sujets classés comme suit: (i) la nécessité de comprendre la perception qu'ont les femmes de l'accouchement vaginal assisté et de fournir des informations appropriées et fiables; (ii) l'importance de la formation des prestataires de soins de santé en matière de compétences cliniques, mais aussi de respect dans les soins de santé, de communication efficace, de prise de décision partagée et de consentement éclairé; ou (iii) les obstacles à la mise en Åuvre et à la durabilité et les facteurs qui les facilitent. Les réactions de femmes nous ont appris qu'il était urgent de reconnaître que l'accouchement, la naissance et le post-partum sont des processus humains intrinsèquement physiologiques et dignes au cours desquels les interventions ne devraient être mises en Åuvre qu'en cas de nécessité. La promotion et/ou la réintroduction de l'accouchement vaginal assisté dans les régions à faibles ressources nécessitent que les pouvoirs publics, les décideurs politiques et les administrations d'hôpitaux soutiennent les prestataires de soins de santé qualifiés, qui pourront à leur tour soutenir respectueusement les femmes pendant l'accouchement.
El acceso a la atención obstétrica de emergencia, incluido el parto vaginal asistido y el parto por cesárea, es crucial para mejorar los resultados de la maternidad y el parto. No obstante, aunque el porcentaje de partos por cesárea ha aumentado en las últimas décadas, el uso del parto vaginal asistido ha disminuido. Esto ocurre especialmente en los países de ingresos bajos y medios, a pesar de que un parto vaginal asistido suele ser menos arriesgado que un parto por cesárea. Por lo tanto, llevamos a cabo un proceso de tres pasos para identificar un programa de investigación necesario para aumentar el uso del parto vaginal asistido o volver a incorporarlo: tras realizar una síntesis de la evidencia, que sirvió de base para una consulta con expertos técnicos que propusieron un programa de investigación inicial, buscamos e integramos las opiniones de las representantes de las mujeres sobre este programa. Este proceso nos ha permitido identificar un programa de investigación exhaustivo, con temas categorizados como: (i) la necesidad de comprender las percepciones de las mujeres sobre el parto vaginal asistido, y proporcionar información adecuada y fiable; (ii) la importancia de formar a los profesionales sanitarios en habilidades clínicas, pero también en atención respetuosa, comunicación efectiva, toma de decisiones compartida y consentimiento informado; o (iii) las barreras y los facilitadores de la implementación y la sostenibilidad. A partir de las opiniones de las mujeres, nos enteramos de la urgente necesidad de reconocer las experiencias del parto, el alumbramiento y el posparto como procesos humanos inherentemente fisiológicos y dignos, en los que las intervenciones solo deben aplicarse si son necesarias. La promoción o la reincoporación del parto vaginal asistido en regiones de escasos recursos exige que los gobiernos, los responsables de formular políticas y los administradores de hospitales apoyen a los profesionales sanitarios capacitados que, a su vez, pueden ayudar a las mujeres en el trabajo de parto y el alumbramiento de manera respetuosa.
Subject(s)
Cesarean Section , Labor, Obstetric , Pregnancy , Female , Humans , Incidence , Delivery, Obstetric , Postpartum PeriodABSTRACT
OBJECTIVE: To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes. DESIGN: A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation. SETTING: Three inner-city UK National Health Service hospitals in London. PARTICIPANTS: Pregnant women with gestational diabetes treated with medication. INTERVENTIONS: 2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally. PRIMARY OUTCOME MEASURES: Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention. SECONDARY OUTCOME MEASURES: Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs. RESULTS: Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders. CONCLUSIONS: It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention. TRIAL REGISTRATION NUMBER: ISRCTN20930880.
Subject(s)
Diabetes Mellitus, Type 2 , Diabetes, Gestational , Metformin , Female , Humans , Pregnancy , Metformin/therapeutic use , Diabetes Mellitus, Type 2/prevention & control , Diabetes Mellitus, Type 2/drug therapy , Diabetes, Gestational/prevention & control , Diabetes, Gestational/drug therapy , Feasibility Studies , State Medicine , Double-Blind Method , United KingdomABSTRACT
The risk of adverse perinatal and maternal outcomes increases with gestational age, and although induction of labour may reduce these risks, the optimal timing of induction remains unknown. We carried out a systematic review and meta-analysis, to determine the gestational age at which induction should be offered. We searched Cochrane Central Register of Controlled Trials, Medline, and Embase databases from inception to July 2022, to identify randomised trials comparing induction of labour at or beyond 37' weeks gestation with expectant management or delayed induction, and according to the gestational age at planned induction. We undertook random effects meta-analysis and pooled estimates as odds ratios with 95% confidence intervals. We assessed risk of bias of studies using the Cochrane Risk of Bias tool 2.0. We included 44 trials (23,960 women and 22,191 offspring) from 1,839 citations in our meta-analysis. The odds of perinatal death (odds ratio 0.42, 95% confidence interval 0.22 to 0.81; 26 studies, 20,154 offspring), stillbirth (0.40, 0.16 to 0.98; 25 studies, 19,412 offspring), admission to neonatal intensive care unit (0.86, 0.78 to 0.96; 23 studies, 18,846 offspring), and caesarean section (0.90, 0.83 to 0.98; 40 studies, 23,616 women) were reduced in the induction of labour group compared to expectant management or delayed induction. The odds of admission to neonatal intensive care unit (0.82, 0.70 to 0.96; 6 studies, 9,316 offspring) were lower with induction of labour at 41 weeks compared to induction at or after 42 weeks' gestation, and the odds of caesarean section were reduced with labour induction at 39 weeks' compared to induction at or after 40 weeks' (0.83, 0.74 to 0.93; 8 studies, 7,677 women). There were no significant differences in pregnancy outcomes by method of induction of labour. Induction of labour compared to expectant management or delayed induction reduces the risk of adverse pregnancy outcomes, and the optimal timing may depend on the specific outcome of interest.
Subject(s)
Cesarean Section , Labor, Obstetric , Infant, Newborn , Pregnancy , Female , Humans , Watchful Waiting , Pregnancy Outcome , Labor, Induced/methodsABSTRACT
BACKGROUND: Heterogeneity in reported outcomes can limit the synthesis of research evidence. A core outcome set informs what outcomes are important and should be measured as a minimum in all future studies. We report the development of a core outcome set applicable to observational and interventional studies of pregnant women with multimorbidity. METHODS: We developed the core outcome set in four stages: (i) a systematic literature search, (ii) three focus groups with UK stakeholders, (iii) two rounds of Delphi surveys with international stakeholders and (iv) two international virtual consensus meetings. Stakeholders included women with multimorbidity and experience of pregnancy in the last 5 years, or are planning a pregnancy, their partners, health or social care professionals and researchers. Study adverts were shared through stakeholder charities and organisations. RESULTS: Twenty-six studies were included in the systematic literature search (2017 to 2021) reporting 185 outcomes. Thematic analysis of the focus groups added a further 28 outcomes. Two hundred and nine stakeholders completed the first Delphi survey. One hundred and sixteen stakeholders completed the second Delphi survey where 45 outcomes reached Consensus In (≥70% of all participants rating an outcome as Critically Important). Thirteen stakeholders reviewed 15 Borderline outcomes in the first consensus meeting and included seven additional outcomes. Seventeen stakeholders reviewed these 52 outcomes in a second consensus meeting, the threshold was ≥80% of all participants voting for inclusion. The final core outcome set included 11 outcomes. The five maternal outcomes were as follows: maternal death, severe maternal morbidity, change in existing long-term conditions (physical and mental), quality and experience of care and development of new mental health conditions. The six child outcomes were as follows: survival of baby, gestational age at birth, neurodevelopmental conditions/impairment, quality of life, birth weight and separation of baby from mother for health care needs. CONCLUSIONS: Multimorbidity in pregnancy is a new and complex clinical research area. Following a rigorous process, this complexity was meaningfully reduced to a core outcome set that balances the views of a diverse stakeholder group.