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BJOG : An International Journal of... Dec 2019There are questions about the use of the 'one-centimetre per hour rule' as a valid benchmark for assessing the adequacy of labour progress.
BACKGROUND
There are questions about the use of the 'one-centimetre per hour rule' as a valid benchmark for assessing the adequacy of labour progress.
OBJECTIVES
To determine the accuracy of the alert (1-cm/hour) and action lines of the cervicograph in the partograph to predict adverse birth outcomes among women in first stage of labour.
SEARCH STRATEGY
PubMed, EMBASE, CINAHL, POPLINE, Global Health Library, and reference lists of eligible studies.
SELECTION CRITERIA
Observational studies and other study designs reporting data on the correlation between the alert line status of women in labour and the occurrence of adverse birth outcomes.
DATA COLLECTION AND ANALYSIS
Two reviewers at a time independently identified eligible studies and independently abstracted data including population characteristics and maternal and perinatal outcomes.
MAIN RESULTS
Thirteen studies in which 20 471 women participated were included in the review. The percentage of women crossing the alert line varied from 8 to 76% for all maternal or perinatal outcomes. No study showed a robust diagnostic test accuracy profile for any of the selected outcomes.
CONCLUSIONS
This systematic review does not support the use of the cervical dilatation over time (at a threshold of 1 cm/h during active first stage) to identify women at risk of adverse birth outcomes.
TWEETABLE ABSTRACT
Alert line of partograph does not identify women at risk of adverse birth outcomes.
Topics: Adult; Cesarean Section; Delivery, Obstetric; Female; Humans; Infant, Newborn; Labor, Obstetric; Predictive Value of Tests; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Reproducibility of Results; Term Birth; Uterine Inertia; Uterine Monitoring
PubMed: 31334912
DOI: 10.1111/1471-0528.15884 -
Health Policy and Planning May 2019Providing quality emergency obstetric care (EmOC) reduces the risk of maternal and newborn mortality and morbidity. There is evidence that over 50% of maternal health...
Providing quality emergency obstetric care (EmOC) reduces the risk of maternal and newborn mortality and morbidity. There is evidence that over 50% of maternal health programmes that result in improving access to EmOC and reduce maternal mortality have an EmOC training component. The objective was to review the evidence for the effectiveness of training in EmOC. Eleven databases and websites were searched for publications describing EmOC training evaluations between 1997 and 2017. Effectiveness was assessed at four levels: (1) participant reaction, (2) knowledge and skills, (3) change in behaviour and clinical practice and (4) availability of EmOC and health outcomes. Weighted means for change in knowledge and skills obtained, narrative synthesis of results for other levels. One hundred and one studies including before-after studies (n = 44) and randomized controlled trials (RCTs) (n = 15). Level 1 and/or 2 was assessed in 68 studies; Level 3 in 51, Level 4 in 21 studies. Only three studies assessed effectiveness at all four levels. Weighted mean scores pre-training, and change after training were 67.0% and 10.6% for knowledge (7750 participants) and 53.1% and 29.8% for skills (6054 participants; 13 studies). There is strong evidence for improved clinical practice (adherence to protocols, resuscitation technique, communication and team work) and improved neonatal outcomes (reduced trauma after shoulder dystocia, reduced number of babies with hypothermia and hypoxia). Evidence for a reduction in the number of cases of post-partum haemorrhage, case fatality rates, stillbirths and institutional maternal mortality is less strong. Short competency-based training in EmOC results in significant improvements in healthcare provider knowledge/skills and change in clinical practice. There is emerging evidence that this results in improved health outcomes.
Topics: Competency-Based Education; Delivery, Obstetric; Emergency Medicine; Female; Health Personnel; Humans; Infant, Newborn; Obstetrics; Pregnancy; Program Evaluation
PubMed: 31056670
DOI: 10.1093/heapol/czz028 -
Ultrasound in Obstetrics & Gynecology :... Sep 2019To determine accurate estimates of risks of maternal and neonatal complications in pregnancies with fetal macrosomia by performing a systematic review of the literature... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To determine accurate estimates of risks of maternal and neonatal complications in pregnancies with fetal macrosomia by performing a systematic review of the literature and meta-analysis.
METHODS
A search of MEDLINE, EMBASE, CINAHL and The Cochrane Library was performed to identify relevant studies reporting on maternal and/or neonatal complications in pregnancies with macrosomia having a birth weight (BW) > 4000 g and/or those with birth weight > 4500 g. Prospective and retrospective cohort and population-based studies that provided data regarding both cases and controls were included. Maternal outcomes assessed were emergency Cesarean section (CS), postpartum hemorrhage (PPH) and obstetric anal sphincter injury (OASIS). Neonatal outcomes assessed were shoulder dystocia, obstetric brachial plexus injury (OBPI) and birth fractures. Meta-analysis using a random-effects model was used to estimate weighted pooled estimates of summary statistics (odds ratio (OR) and 95% CI) for each complication, according to birth weight. Heterogeneity between studies was estimated using Cochran's Q, I statistic and funnel plots.
RESULTS
Seventeen studies reporting data on maternal and/or neonatal complications in pregnancy with macrosomia were included. In pregnancies with macrosomia having a BW > 4000 g, there was an increased risk of the maternal complications: emergency CS, PPH and OASIS, which had OR (95% CI) of 1.98 (1.80-2.18), 2.05 (1.90-2.22) and 1.91 (1.56-2.33), respectively. The corresponding values for pregnancies with BW > 4500 g were: 2.55 (2.33-2.78), 3.15 (2.14-4.63) and 2.56 (1.97-3.32). Similarly, in pregnancies with a BW > 4000 g, there was an increased risk of the neonatal complications: shoulder dystocia, OBPI and birth fractures, which had OR (95% CI) of 9.54 (6.76-13.46), 11.03 (7.06-17.23) and 6.43 (3.67-11.28), respectively. The corresponding values for pregnancies with a BW > 4500 g were: 15.64 (11.31-21.64), 19.87 (12.19-32.40) and 8.16 (2.75-24.23).
CONCLUSION
Macrosomia is associated with serious maternal and neonatal adverse outcomes. This study provides accurate estimates of these risks, which can be used for decisions on pregnancy management. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Adult; Cesarean Section; Dystocia; Female; Fetal Macrosomia; Humans; Infant, Newborn; Infant, Newborn, Diseases; Postpartum Hemorrhage; Pregnancy; Pregnancy Complications; Retrospective Studies
PubMed: 30938004
DOI: 10.1002/uog.20279 -
Paediatric and Perinatal Epidemiology Jan 2019Currently, no federal guidelines provide recommendations on healthy birth spacing for women in the United States. This systematic review summarises associations between...
BACKGROUND
Currently, no federal guidelines provide recommendations on healthy birth spacing for women in the United States. This systematic review summarises associations between short interpregnancy intervals and adverse maternal outcomes to inform the development of birth spacing recommendations for the United States.
METHODS
PubMed/Medline, POPLINE, EMBASE, CINAHL, the Cochrane Database of Systematic Reviews, and a previous systematic review were searched to identify relevant articles published from 1 January 2006 and 1 May 2017. Included studies reported maternal health outcomes following a short versus longer interpregnancy interval, were conducted in high-resource settings, and adjusted estimates for at least maternal age. Two investigators independently assessed study quality and applicability using established methods.
RESULTS
Seven cohort studies met inclusion criteria. There was limited but consistent evidence that short interpregnancy interval is associated with increased risk of precipitous labour and decreased risks of labour dystocia. There was some evidence that short interpregnancy interval is associated with increased risks of subsequent pre-pregnancy obesity and gestational diabetes, and decreased risk of preeclampsia. Among women with a previous caesarean delivery, short interpregnancy interval was associated with increased risk of uterine rupture in one study. No studies reported outcomes related to maternal depression, interpregnancy weight gain, maternal anaemia, or maternal mortality.
CONCLUSIONS
In studies from high-resource settings, short interpregnancy intervals are associated with both increased and decreased risks of adverse maternal outcomes. However, most outcomes were evaluated in single studies, and the strength of evidence supporting associations is low.
Topics: Birth Intervals; Female; Humans; Maternal Age; Obstetric Labor Complications; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Socioeconomic Factors
PubMed: 30311955
DOI: 10.1111/ppe.12518 -
JBI Database of Systematic Reviews and... Feb 2019The objective of this review was to identify, assess and synthesize the best available evidence on the effects of induction prior to post-term on the mother and fetus....
OBJECTIVE
The objective of this review was to identify, assess and synthesize the best available evidence on the effects of induction prior to post-term on the mother and fetus. Maternal and fetal outcomes after routine labor induction in low-risk pregnancies at 41+0 to 41+6 gestational weeks (prior to post-term) were compared to routine labor induction at 42+0 to 42+6 gestational weeks (post-term).
INTRODUCTION
Induction of labor when a pregnancy exceeds 14 days past the estimated due date has long been used as an intervention to prevent adverse fetal and maternal outcomes. Over the last decade, clinical procedures have changed in many countries towards earlier induction. A shift towards earlier inductions may lead to 15-20% more inductions. Given the fact that induction as an intervention can cause harm to both mother and child, it is essential to ensure that the benefits of the change in clinical practice outweigh the harms.
INCLUSION CRITERIA
This review included studies with participants with expected low-risk deliveries, where both fetus and mother were considered healthy at inclusion and with no known risks besides the potential risk of the ongoing pregnancy. Included studies evaluated induction at 41+1-6 gestational weeks compared to 42+1-6 gestational weeks. Randomized control trials (n = 2), quasi-experimental trials (n = 2), and cohort studies (n = 3) were included. The primary outcomes of interest were cesarean section, instrumental vaginal delivery, low Apgar score (≤ 7/5 min.), and low pH (< 7.10). Secondary outcomes included additional indicators of fetal or maternal wellbeing related to prolonged pregnancy or induction.
METHODS
The following information sources were searched for published and unpublished studies: PubMed, CINAHL, Embase, Scopus, Swemed+, POPLINE; Cochrane, TRIP; Current Controlled Trials; Web of Science, and, for gray literature: MedNar; Google Scholar, ProQuest Nursing & Allied Health Source, and guidelines from the Royal College of Obstetricians and Gynaecologists, and American College of Obstetricians and Gynecologists, according to the published protocol. In addition, OpenGrey and guidelines from the National Institute for Health and Care Excellence, World Health Organization, and Society of Obstetricians and Gynaecologists of Canada were sought. Included papers were assessed by all three reviewers independently using the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). The standardized data extraction tool from JBI SUMARI was used. Data were pooled in a statistical meta-analysis model using RevMan 5, when the criteria for meta-analysis were met. Non-pooled results were presented separately.
RESULTS
Induction at 41+0-6 gestational weeks compared to 42+0-6 gestational weeks was found to be associated with an increased risk of overall cesarean section (relative risk [RR] = 1.11, 95% confidence interval [CI] 1.09-1.14), cesarean section due to failure to progress (RR = 1.43, 95% CI 1.01-2.01), chorioamnionitis (RR = 1.13, 95% CI 1.05-1.21), labor dystocia (RR = 1.29, 95% CI 1.22-1.37), precipitate labor (RR = 2.75, 95% CI 1.45-5.2), uterine rupture (RR = 1.97, 95% CI 1.54-2.52), pH < 7.10 (RR = 1.9, 95% CI 1.48-2.43), and a decreased risk of oligohydramnios (RR = 0.4, 95% CI 0.24-0.67) and meconium stained amniotic fluid (RR = 0.82, 95% CI 0.75-0.91). Data lacked statistical power to draw conclusions on perinatal death. No differences were seen for postpartum hemorrhage, shoulder dystocia, meconium aspiration, 5-minute Apgar score < 7, or admission to neonatal intensive care unit. A policy of awaiting spontaneous onset of labor until 42+0-6 gestational weeks showed, that approximately 70% went into spontaneous labor.
CONCLUSIONS
Induction prior to post-term was associated with few beneficial outcomes and several adverse outcomes. This draws attention to possible iatrogenic effects affecting large numbers of low-risk women in contemporary maternity care. According to the World Health Organization, expected benefits from a medical intervention must outweigh potential harms. Hence, our results do not support the widespread use of routine induction prior to post-term (41+0-6 gestational weeks).
Topics: Adult; Apgar Score; Case-Control Studies; Cesarean Section; Chorioamnionitis; Delivery, Obstetric; Dystocia; Female; Fetus; Gestational Age; Humans; Infant, Newborn; Labor, Induced; Labor, Obstetric; Maternal Health Services; Meconium Aspiration Syndrome; Middle Aged; Oligohydramnios; Perinatal Death; Pregnancy; Pregnancy Outcome; Uterine Rupture
PubMed: 30299344
DOI: 10.11124/JBISRIR-2017-003587 -
Human Reproduction (Oxford, England) Oct 2018How is endometriosis associated with adverse maternal, fetal and neonatal outcomes of pregnancy? (Meta-Analysis)
Meta-Analysis
STUDY QUESTION
How is endometriosis associated with adverse maternal, fetal and neonatal outcomes of pregnancy?
SUMMARY ANSWER
Women with endometriosis are at elevated risk for serious and important adverse maternal (pre-eclampsia, gestational diabetes, placenta praevia and Cesarean section) and fetal or neonatal outcomes (preterm birth, PPROM, small for gestational age, stillbirth and neonatal death).
WHAT IS KNOWN ALREADY
A number of studies have shown an association between endometriosis and certain adverse maternal and fetal outcomes, but the results have been conflicting with potential for confounding by the use of assisted reproductive technology.
STUDY DESIGN, SIZE, DURATION
A systematic review and meta-analysis of observational studies (1 January 1990-31 December 2017) that evaluated the effect of endometriosis on maternal, fetal and neonatal outcomes was conducted.
PARTICIPANTS/MATERIALS, SETTING, METHODS
Studies were considered for inclusion if they were prospective or retrospective cohort or case-control studies; included women greater than 20 weeks gestational age with endometriosis; included a control group of gravid women without endometriosis; and, reported at least one of the outcomes of interest. Each study was reviewed for inclusion, data were extracted and risk of bias was assessed by two independent reviewers.
MAIN RESULTS AND THE ROLE OF CHANCE
The search strategy identified 33 studies (sample size, n = 3 280 488) for inclusion. Compared with women without endometriosis, women with endometriosis had higher odds of pre-eclampsia (odds ratio [OR] = 1.18 [1.01-1.39]), gestational hypertension and/or pre-eclampsia (OR = 1.21 [1.05-1.39]), gestational diabetes (OR = 1.26 [1.03-1.55]), gestational cholestasis (OR = 4.87 [1.85-12.83]), placenta praevia (OR = 3.31 [2.37, 4.63]), antepartum hemorrhage (OR = 1.69 [1.38-2.07]), antepartum hospital admissions (OR = 3.18 [2.60-3.87]), malpresentation (OR = 1.71 [1.34, 2.18]), labor dystocia (OR = 1.45 [1.04-2.01]) and cesarean section (OR = 1.86 [1.51-2.29]). Fetuses and neonates of women with endometriosis were also more likely to have preterm premature rupture of membranes (OR = 2.33 [1.39-3.90]), preterm birth (OR = 1.70 [1.40-2.06]), small for gestational age <10th% (OR = 1.28 [1.11-1.49]), NICU admission (OR = 1.39 [1.08-1.78]), stillbirth (OR = 1.29 [1.10, 1.52]) and neonatal death (MOR = 1.78 [1.46-2.16]). Among the subgroup of women who conceived spontaneously, endometriosis was found to be associated with placenta praevia, cesarean section, preterm birth and low birth weight. Among the subgroup of women who conceived with the use of assisted reproductive technology, endometriosis was found to be associated with placenta praevia and preterm birth.
LIMITATIONS, REASONS FOR CAUTION
As with any systematic review, the review is limited by the quality of the included studies. The diagnosis for endometriosis and the selection of comparison groups were not uniform across studies. However, the effect of potential misclassification would be bias towards the null hypothesis.
WIDER IMPLICATIONS OF THE FINDINGS
The association between endometriosis with the important and serious pregnancy outcomes observed in our meta-analysis, in particular stillbirth and neonatal death, is concerning and warrants further studies to elucidate the mechanisms for the observed findings.
STUDY FUNDING/COMPETING INTEREST(S)
Dr Shifana Lalani is supported by a Physicians' Services Incorporated Foundation Research Grant, and Dr Innie Chen is supported by a University of Ottawa Clinical Research Chair in Reproductive Population Health and Health Services. Dr Singh declares conflicts of interests with Bayer, Abvie, Allergan and Cooper Surgical. All other authors have no conflicts of interests to declare.
REGISTRATION NUMBER
PROSPERO CRD42015013911.
Topics: Case-Control Studies; Cesarean Section; Diabetes, Gestational; Endometriosis; Female; Humans; Infant, Newborn; Perinatal Death; Placenta Previa; Postpartum Hemorrhage; Pre-Eclampsia; Pregnancy; Premature Birth; Prospective Studies; Retrospective Studies; Stillbirth
PubMed: 30239732
DOI: 10.1093/humrep/dey269 -
The Cochrane Database of Systematic... Aug 2018The partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The partograph (sometimes known as partogram) is usually a pre-printed paper form on which labour observations are recorded. The aim of the partograph is to provide a pictorial overview of labour, and to alert midwives and obstetricians to deviations in maternal or fetal well-being and labour progress. Charts have traditionally contained pre-printed alert and action lines. An alert line, which is based on the slowest 10% of primigravid women's labours, signifies slow progress. An action line is placed a number of hours after the alert line (usually two or four hours) to prompt effective management of slow progress of labour.This review is an update of a review last published in 2013.
OBJECTIVES
The primary objective was to determine the effectiveness and safety of partograph use on perinatal and maternal morbidity and mortality. The secondary objective was to determine which partograph design is most effective for perinatal and maternal morbidity and mortality outcomes.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 August 2017), ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (31 August 2017) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised, cluster-randomised, and quasi-randomised controlled trials involving a comparison of partograph use with no partograph, or comparison between different partograph designs.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed eligibility, quality and extracted data. When one review author was also the trial author, the two remaining review authors assessed the studies independently. We assessed the evidence using the GRADE approach.
MAIN RESULTS
We have included 11 studies, involving 9475 women in this review; three studies assessed partograph use versus no partograph, seven assessed different partograph designs, and one assessed partograph use versus labour scale. Risk of bias varied in all studies. It was infeasible to blind staff or women to the intervention. Two studies did not adequately conceal allocation. Loss to follow-up was low in all studies. We assessed the evidence for partograph use versus no partograph using the GRADE approach; downgrading decisions were due to study design, inconsistency, indirectness, and imprecision of effect estimates.Most trials reported caesarean section rates and Apgar scores less than 7 at five minutes; all other outcomes were not consistently reported (e.g. duration of first stage of labour and maternal experience of childbirth).Partograph versus no partograph (3 trials, 1813 women)It is uncertain whether there is any clear difference between partograph use and no partograph in caesarean section rates (average risk ratio (RR) 0.77, 95% confidence interval (CI) 0.40 to 1.46; n = 1813; 3 trials; I² = 87%; very low-quality evidence); oxytocin augmentation (RR 1.02, 95% CI 0.95 to 1.10; n = 1156; 1 trial; moderate-quality evidence); duration of first stage of labour (mean difference (MD) 0.80 hours, 95% CI -0.06 to 1.66; n = 1156; 1 trial; low-quality evidence); or Apgar score less than 7 at five minutes (RR 0.76, 95% CI 0.29 to 2.03; n = 1596; 2 trials; I² = 87%; very low-quality evidence).Partograph with different placement of action lines (4 trials, 5051 women)When compared to a four-hour action line, women in the two-hour action line group were more likely to receive oxytocin augmentation (average RR 2.44, 95% CI 1.36 to 4.35; n = 4749; 4 trials; I² = 96%). There was no clear difference in caesarean section rates (RR 1.06, 95% CI 0.88 to 1.28; n = 4749; 4 trials); duration of first stage of labour (RR 0.81 hours, 95% CI 0.32 to 2.04; n = 948; 1 trial); maternal experience of childbirth (average RR 0.61, 95% CI 0.28 to 1.35; n = 2269; 2 trials; I² = 83%); or Apgar score less than 7 at five minutes (RR 0.93, 95% CI 0.61 to 1.42; n = 4749; 4 trials) between the two- and four-hour action line.The following comparisons only include data from single studies. Fewer women reported negative childbirth experiences in the two-hour action line group compared to the three-hour action line group (RR 0.49, 95% CI 0.27 to 0.90; n = 348; 1 trial). When we compared the three- and four-hour action line groups, the caesarean section rate was higher in the three-hour action line group (RR 1.70, 95% CI 1.07 to 2.70; n = 613; 1 trial). We did not observe any clear differences in any of the other outcomes in these comparisons.Partograph with alert line only versus partograph with alert and action line (1 trial, 694 women)The caesarean section rate was lower in the alert line only group (RR 0.68, 95% CI 0.50 to 0.93). There were no clear differences between groups for oxytocin augmentation, low Apgar score, instrumental vaginal birth and perinatal death.Partograph with latent phase (composite) versus partograph without latent phase (modified) (1 trial, 743 women)The caesarean section and oxytocin augmentation rates were higher in the partograph with a latent phase (RR 2.45, 95% CI 1.72 to 3.50; and RR 2.18, 95% CI 1.67 to 2.83, respectively). There were no clear differences between groups for oxytocin augmentation, and Apgar score less than 7 at five minutes.Partograph with two-hour action line versus partograph with stepped dystocia line (1 trial, 99 women)Fewer women received oxytocin augmentation in the dystocia line group (RR 0.62, 95% CI 0.39 to 0.98). We did not observe any clear differences in any of the other primary outcomes in this comparison.Partograph versus labour scale (1 trial, 122 women)The use of the partograph compared with the labour scale resulted in fewer women receiving oxytocin augmentation (RR 0.32, 95% CI 0.18 to 0.54), but did not produce any clear differences for any of the other primary outcomes.
AUTHORS' CONCLUSIONS
On the basis of the findings of this review, we cannot be certain of the effects of routine use of the partograph as part of standard labour management and care, or which design, if any, are most effective. Further trial evidence is required to establish the efficacy of partograph use per se and its optimum design.
Topics: Cesarean Section; Delivery, Obstetric; Female; Humans; Labor, Obstetric; Medical Records; Oxytocics; Oxytocin; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Term Birth; Time Factors; Uterine Inertia; Uterine Monitoring
PubMed: 30080256
DOI: 10.1002/14651858.CD005461.pub5 -
The Cochrane Database of Systematic... Jul 2018There has been considerable interest in providing antenatal dietary and lifestyle advice for women with obesity or who are overweight during pregnancy, as a strategy to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There has been considerable interest in providing antenatal dietary and lifestyle advice for women with obesity or who are overweight during pregnancy, as a strategy to limit gestational weight gain and improve maternal and infant health. However, such antenatal interventions appear to have a modest effect on gestational weight gain and other clinical pregnancy and birth outcomes and additional strategies are required.Metformin is an oral insulin-sensitising medication that acts to decrease blood glucose concentrations. Metformin is commonly used in the treatment of type 2 diabetes mellitus and polycystic ovarian syndrome, and is being used increasingly in the treatment of gestational diabetes, having been shown to result in decreased rates of caesarean birth and neonatal hypoglycaemia. Metformin may be an adjuvant therapy to current antenatal strategies in pregnant women with obesity or who are overweight, acting to reduce glucose production in the liver and improve glucose uptake in smooth muscle cells, and therefore improve the overall metabolic health of women in pregnancy and reduce the risk of known adverse pregnancy outcomes.
OBJECTIVES
To evaluate the role of metformin in pregnant women with obesity or who are overweight, on maternal and infant outcomes, including adverse effects of treatment and costs.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (11 October 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
All published and unpublished randomised controlled trials evaluating metformin use (compared with placebo or no metformin) in women with obesity or who are overweight in pregnancy for improving outcomes, alone or in combination with other interventions were eligible for inclusion.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We used the GRADE approach to assess the quality of the evidence.
MAIN RESULTS
We included three studies which randomised women (1099) with a body mass index (BMI) of 30 kg/m (1 study) and 35 kg/m (2 studies), with outcomes available for 1034 participants. None of the studies assessed women with a BMI between 25 kg/mand 29.9 kg/m, therefore we could not assess the use of metformin in women considered overweight. We did not identify studies of metformin in combination with another treatment. Two other studies are ongoing.All three included studies were randomised controlled trials and compared metformin with placebo, commencing early in the second trimester. Doses ranged from 500 mg twice daily to 3.0 g per day. All three studies (two in the UK, one in Egypt) included women attending hospitals for antenatal care.Two studies were generally at a low risk of bias across the majority of domains. We assessed the third study as being at an unclear risk of selection bias, performance and detection bias due to insufficient information in the report. We assessed the trial as being at a low risk of attrition bias and other bias; we felt it was at a high risk of reporting bias.The primary outcome for this review was infant birthweight large-for-gestational-age (> 90th centile for gestational age and infant sex). Women who received metformin or placebo had a similar risk of their baby being born large for his or her gestational age (risk ratio (RR) 0.95, 95% confidence interval (CI) 0.70 to 1.30; 2 studies, 831 infants; high-quality evidence).Women who received metformin may have a slightly lower gestational weight gain (mean difference (MD) -2.60 kg, 95% CI -5.29 to 0.10; 3 studies, 899 women; low-quality evidence).Metformin may make little or no difference in the risk of women developing gestational hypertension (average RR 1.02, 95% CI 0.54 to 1.94; 3 studies, 1040 women; low-quality evidence) or pre-eclampsia (RR 0.74, 95% CI 0.09 to 6.28; 2 studies, 840 women; low-quality evidence). Metformin probably makes little or no difference in the risk of women developing gestational diabetes (RR 0.85, 95% CI 0.61 to 1.19; 3 studies, 892 women; moderate-quality evidence).One study of 400 women reported women receiving metformin were more likely to experience any adverse effect compared with women receiving placebo (RR 1.63, 95% CI 1.27 to 2.08; 1 study, 400 women). Adverse effects included abdominal pain, diarrhoea, or headache. When considering individual side effects, women receiving metformin were more likely to experience diarrhoea than women receiving placebo (RR 2.34, 95% CI 1.74 to 3.14; 797 women; 2 studies, 797 women; high-quality evidence). No other important differences were identified between Metformin and placebo for other maternal secondary outcomes, including: caesarean birth, birth before 37 weeks of pregnancy, shoulder dystocia, perineal tear, or postpartum haemorrhage.In terms of other infant outcomes, there was little or no difference in the infant birthweight (MD 6.39 g, 95% CI -81.15 to 93.92; 2 studies, 834 infants; high-quality evidence). There were no other important differences identified for other infant secondary outcomes in this review: hypoglycaemia (low blood sugar); hyperbilirubinaemia (jaundice); Apgar score less than 7 at five minutes; or stillbirth and neonatal death. Only one study reported admission to the neonatal intensive care unit (NICU), indicating similar rates of admission between women receiving metformin or placebo; no other admission data were reported to assess differences in costs.
AUTHORS' CONCLUSIONS
There is insufficient evidence to support the use of metformin for women with obesity in pregnancy for improving maternal and infant outcomes. Metformin was, however, associated with increased risk of adverse effects, particularly diarrhoea. The quality of the evidence in this review varied from high to low, with downgrading decisions based on study limitations and inconsistency.There were only a small number of studies included in this review. Furthermore, none of the included studies included women categorised as 'overweight' and no trials looked at metformin in combination with another treatment.Future research is required in order to further evaluate the role of metformin therapy in pregnant women with obesity or who are overweight, as a strategy to improve maternal and infant health, alone or as an adjuvant to dietary and lifestyle advice.
Topics: Birth Weight; Body Mass Index; Female; Humans; Hypertension; Hypoglycemic Agents; Infant, Newborn; Metformin; Obesity; Overweight; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Randomized Controlled Trials as Topic; Weight Gain
PubMed: 30039871
DOI: 10.1002/14651858.CD010564.pub2 -
BMC Women's Health Jun 2018Women with fistula live in a state of distress and in fear of their future life. An obstetric fistula has a devastating impact on affected women and their families. The...
BACKGROUND
Women with fistula live in a state of distress and in fear of their future life. An obstetric fistula has a devastating impact on affected women and their families. The objective of this systematic review was to synthesize the evidence from published articles on the consequences of obstetric fistula on women who endure the condition.
METHODS
The consequences were systematically reviewed from purely qualitative and mixed method primary studies. The literatures were searched through the search engines Google, Google scholar, Hinari using Pub Med data bases, and citation tracking. Relevant source of publications were searched for primary qualitative studies by formulating search protocol using related search terms. Time (articles published between January first of 2007 and 30th September 2016), participants (women who experienced obstetric fistula due to obstructed labor complications), types of study (purely qualitative and mixed method primary articles), findings (reporting consequences/impacts of obstetric fistula) were used as inclusion criteria. The quality appraisal tool for qualitative studies and the critical appraisal skills program were used to appraise the quality of the studies. The findings of sixteen studies were included in the review. The data were collected and then a thematic framework approach was applied for analysis.
RESULTS
The thematic categories shared across most studies were related to the physical challenges of losing body control, women's social and family relationships, and the challenges of losing income. Obstetric fistula has far reaching consequences on women's physical well being, social and marital relationships, mental health and economic capacity. Fistula also challenged women coping abilities.
CONCLUSION
The consequences of obstetric fistula are far more than the visible medical condition. Little evidence is available on mental health, child and fertility issues, and coping mechanisms. Therefore, further researches shall be aimed at addressing the understudied area and suitable interventions shall be offered to improve women's overall quality of life.
Topics: Africa South of the Sahara; Divorce; Dystocia; Female; Humans; Income; Interpersonal Relations; Mental Health; Pregnancy; Qualitative Research; Quality of Life; Rectovaginal Fistula; Vesicovaginal Fistula
PubMed: 29925358
DOI: 10.1186/s12905-018-0605-1 -
The Cochrane Database of Systematic... Jan 2018Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience adverse health outcomes such as... (Review)
Review
BACKGROUND
Gestational diabetes is a type of diabetes that occurs during pregnancy. Women with gestational diabetes are more likely to experience adverse health outcomes such as pre-eclampsia or polyhydramnios (excess amniotic fluid). Their babies are also more likely to have health complications such as macrosomia (birthweight > 4000 g) and being large-for-gestational age (birthweight above the 90th percentile for gestational age). Current clinical guidelines support elective birth, at or near term in women with gestational diabetes to minimise perinatal complications, especially those related to macrosomia.This review replaces a review previously published in 2001 that included "diabetic pregnant women", which has now been split into two reviews. This current review focuses on pregnant women with gestational diabetes and a sister review focuses on women with pre-existing diabetes (Type 1 or Type 2).
OBJECTIVES
To assess the effect of planned birth (either by induction of labour or caesarean birth), at or near term (37 to 40 weeks' gestation) compared with an expectant approach for improving health outcomes for women with gestational diabetes and their infants. The primary outcomes relate to maternal and perinatal mortality and morbidity.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) (15 August 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised trials comparing planned birth, at or near term (37 to 40 weeks' gestation), with an expectant approach, for women with gestational diabetes. Cluster-randomised and non-randomised trials (e.g. quasi-randomised trials using alternate allocation) were also eligible for inclusion but none were identified.
DATA COLLECTION AND ANALYSIS
Two of the review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included study. The quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS
The findings of this review are based on a single trial involving 425 women with gestational diabetes. The trial compared induction of labour with expectant management (waiting for the spontaneous onset of labour in the absence of any maternal or fetal issues that may necessitate birth) in pregnant women with gestational diabetes at term. We assessed the overall risk of bias as being low for most domains, apart from performance, detection and attrition bias (for outcome perineum intact), which we assessed as being at high risk. It was an open-label trial, and women and healthcare professionals were not blinded.There were no clear differences between women randomised to induction of labour and women randomised to expectant management for maternal mortality or serious maternal morbidity (risk ratio (RR) 1.48, 95% confidence interval (CI) 0.25 to 8.76, one trial, 425 women); caesarean section (RR 1.06, 95% CI 0.64 to 1.77, one trial, 425 women); or instrumental vaginal birth (RR 0.81, 95% CI 0.45 to 1.46, one trial, 425 women). For the primary outcome of maternal mortality or serious maternal morbidity, there were no deaths in either group and serious maternal morbidity related to admissions to intensive care unit. The quality of the evidence contributing to these outcomes was assessed as very low, mainly due to the study having high risk of bias for some domains and because of the imprecision of effect estimates.In relation to primary neonatal outcomes, there were no perinatal deaths in either group. The quality of evidence for this outcome was judged as very low, mainly due to high risk of bias and imprecision of effect estimates. There were no clear differences in infant outcomes between women randomised to induction of labour and women randomised to expectant management: shoulder dystocia (RR 2.96, 95% CI 0.31 to 28.21, one trial, 425 infants, very low-quality evidence); large-for-gestational age (RR 0.53, 95% CI 0.28 to 1.02, one trial, 425 infants, low-quality evidence).There were no clear differences between women randomised to induction of labour and women randomised to expectant management for postpartum haemorrhage (RR 1.17, 95% CI 0.53 to 2.54, one trial, 425 women); admission to intensive care unit (RR 1.48, 95% CI 0.25 to 8.76, one trial, 425 women); and intact perineum (RR 1.02, 95% CI 0.73 to 1.43, one trial, 425 women). No infant experienced a birth trauma, therefore, we could not draw conclusions about the effect of the intervention on the outcomes of brachial plexus injury and bone fracture at birth. Infants of women in the induction-of-labour group had higher incidences of neonatal hyperbilirubinaemia (jaundice) when compared to infants of women in the expectant-management group (RR 2.46, 95% CI 1.11 to 5.46, one trial, 425 women).We found no data on the following prespecified outcomes of this review: postnatal depression, maternal satisfaction, length of postnatal stay (mother), acidaemia, intracranial haemorrhage, hypoxia ischaemic encephalopathy, small-for-gestational age, length of postnatal stay (baby) and cost.The authors of this trial acknowledge that it is underpowered for their primary outcome of caesarean section. The authors of the trial and of this review note that the CIs demonstrate a wide range, therefore making it inappropriate to draw definite conclusions.
AUTHORS' CONCLUSIONS
There is limited evidence to inform implications for practice. The available data are not of high quality and lack power to detect possible important differences in either benefit or harm. There is an urgent need for high-quality trials evaluating the effectiveness of planned birth at or near term gestation for women with gestational diabetes compared with an expectant approach.
Topics: Cesarean Section; Diabetes, Gestational; Female; Fetal Macrosomia; Humans; Infant; Labor, Induced; Pregnancy; Term Birth; Watchful Waiting
PubMed: 29303230
DOI: 10.1002/14651858.CD012910