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BJOG : An International Journal of... Jul 2018The call for women-centred approaches to reduce labour interventions, particularly primary caesarean section, has renewed an interest in gaining a better understanding...
BACKGROUND
The call for women-centred approaches to reduce labour interventions, particularly primary caesarean section, has renewed an interest in gaining a better understanding of natural labour progression.
OBJECTIVE
To synthesise available data on the cervical dilatation patterns during spontaneous labour of 'low-risk' women with normal perinatal outcomes.
SEARCH STRATEGY
PubMed, EMBASE, CINAHL, POPLINE, Global Health Library, and reference lists of eligible studies.
SELECTION CRITERIA
Observational studies and other study designs.
DATA COLLECTION AND ANALYSIS
Two authors extracted data on: maternal characteristics; labour interventions; the duration of labour centimetre by centimetre; and the duration of labour from dilatation at admission through to 10 cm. We pooled data across studies using weighted medians and employed the Bootstrap-t method to generate the corresponding confidence bounds.
MAIN RESULTS
Seven observational studies describing labour patterns for 99 971 women met our inclusion criteria. The median time to advance by 1 cm in nulliparous women was longer than 1 hour until a dilatation of 5 cm was reached, with markedly rapid progress after 6 cm. Similar labour progression patterns were observed in parous women. The 95th percentiles for both parity groups suggest that it was not uncommon for some women to reach 10 cm, despite dilatation rates that were much slower than the 1-cm/hour threshold for most part of their first stage of labours.
CONCLUSION
An expectation of a minimum cervical dilatation threshold of 1 cm/hour throughout the first stage of labour is unrealistic for most healthy nulliparous and parous women. Our findings call into question the universal application of clinical standards that are conceptually based on an expectation of linear labour progress in all women.
FUNDING
UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research, World Health Organization, and the United States Agency for International Development (USAID).
TWEETABLE ABSTRACT
Cervical dilatation threshold of 1 cm/hour throughout labour is unrealistic for most women, regardless of parity.
Topics: Adult; Female; Humans; Labor Stage, First; Parity; Pregnancy; Pregnancy Outcome; Risk Factors; Time Factors; Young Adult
PubMed: 28892266
DOI: 10.1111/1471-0528.14930 -
The Cochrane Database of Systematic... Aug 2017Gestational diabetes mellitus (GDM) is a form of diabetes that occurs in pregnancy. Although GDM usually resolves following birth, it is associated with significant... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Gestational diabetes mellitus (GDM) is a form of diabetes that occurs in pregnancy. Although GDM usually resolves following birth, it is associated with significant morbidities for mothers and their infants in the short and long term. There is strong evidence to support treatment for GDM. However, there is uncertainty as to whether or not screening all pregnant women for GDM will improve maternal and infant health and if so, the most appropriate setting for screening. This review updates a Cochrane Review, first published in 2010, and subsequently updated in 2014.
OBJECTIVES
To assess the effects of screening for gestational diabetes mellitus based on different risk profiles and settings on maternal and infant outcomes.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register (31 January 2017), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (14 June 2017), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised and quasi-randomised trials evaluating the effects of different protocols, guidelines or programmes for screening for GDM based on different risk profiles and settings, compared with the absence of screening, or compared with other protocols, guidelines or programmes for screening. We planned to include trials published as abstracts only and cluster-randomised trials, but we did not identify any. Cross-over trials are not eligible for inclusion in this review.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included trials. We resolved disagreements through discussion or through consulting a third reviewer.
MAIN RESULTS
We included two trials that randomised 4523 women and their infants. Both trials were conducted in Ireland. One trial (which quasi-randomised 3742 women, and analysed 3152 women) compared universal screening versus risk factor-based screening, and one trial (which randomised 781 women, and analysed 690 women) compared primary care screening versus secondary care screening. We were not able to perform meta-analyses due to the different interventions and comparisons assessed.Overall, there was moderate to high risk of bias due to one trial being quasi-randomised, inadequate blinding, and incomplete outcome data in both trials. We used GRADEpro GDT software to assess the quality of the evidence for selected outcomes for the mother and her child. Evidence was downgraded for study design limitations and imprecision of effect estimates. Universal screening versus risk-factor screening (one trial) MotherMore women were diagnosed with GDM in the universal screening group than in the risk-factor screening group (risk ratio (RR) 1.85, 95% confidence interval (CI) 1.12 to 3.04; participants = 3152; low-quality evidence). There were no data reported under this comparison for other maternal outcomes including hypertensive disorders of pregnancy, caesarean birth, perineal trauma, gestational weight gain, postnatal depression, and type 2 diabetes. ChildNeonatal outcomes: large-for-gestational age, perinatal mortality, mortality or morbidity composite, hypoglycaemia; and childhood/adulthood outcomes: adiposity, type 2 diabetes, and neurosensory disability, were not reported under this comparison. Primary care screening versus secondary care screening (one trial) MotherThere was no clear difference between the primary care and secondary care screening groups for GDM (RR 0.91, 95% CI 0.50 to 1.66; participants = 690; low-quality evidence), hypertension (RR 1.41, 95% CI 0.77 to 2.59; participants = 690; low-quality evidence), pre-eclampsia (RR 0.80, 95% CI 0.36 to 1.78; participants = 690;low-quality evidence), or caesarean section birth (RR 1.00, 95% CI 0.80 to 1.27; participants = 690; low-quality evidence). There were no data reported for perineal trauma, gestational weight gain, postnatal depression, or type 2 diabetes. ChildThere was no clear difference between the primary care and secondary care screening groups for large-for-gestational age (RR 1.37, 95% CI 0.96 to 1.96; participants = 690; low-quality evidence), neonatal complications: composite outcome, including: hypoglycaemia, respiratory distress, need for phototherapy, birth trauma, shoulder dystocia, five minute Apgar less than seven at one or five minutes, prematurity (RR 0.99, 95% CI 0.57 to 1.71; participants = 690; low-quality evidence), or neonatal hypoglycaemia (RR 1.10, 95% CI 0.28 to 4.38; participants = 690; very low-quality evidence). There was one perinatal death in the primary care screening group and two in the secondary care screening group (RR 1.10, 95% CI 0.10 to 12.12; participants = 690; very low-quality evidence). There were no data for neurosensory disability, or childhood/adulthood adiposity or type 2 diabetes.
AUTHORS' CONCLUSIONS
There are insufficient randomised controlled trial data evaluating the effects of screening for GDM based on different risk profiles and settings on maternal and infant outcomes. Low-quality evidence suggests universal screening compared with risk factor-based screening leads to more women being diagnosed with GDM. Low to very low-quality evidence suggests no clear differences between primary care and secondary care screening, for outcomes: GDM, hypertension, pre-eclampsia, caesarean birth, large-for-gestational age, neonatal complications composite, and hypoglycaemia.Further, high-quality randomised controlled trials are needed to assess the value of screening for GDM, which may compare different protocols, guidelines or programmes for screening (based on different risk profiles and settings), with the absence of screening, or with other protocols, guidelines or programmes. There is a need for future trials to be sufficiently powered to detect important differences in short- and long-term maternal and infant outcomes, such as those important outcomes pre-specified in this review. As only a proportion of women will be diagnosed with GDM in these trials, large sample sizes may be required.
Topics: Diabetes, Gestational; Female; Glucose Tolerance Test; Humans; Infant Welfare; Infant, Newborn; Mass Screening; Maternal Welfare; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 28771289
DOI: 10.1002/14651858.CD007222.pub4 -
BMJ Open Jun 2017To investigate the effectiveness of different treatments for gestational diabetes mellitus (GDM). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To investigate the effectiveness of different treatments for gestational diabetes mellitus (GDM).
DESIGN
Systematic review, meta-analysis and network meta-analysis.
METHODS
Data sources were searched up to July 2016 and included MEDLINE and Embase. Randomised trials comparing treatments for GDM (packages of care (dietary and lifestyle interventions with pharmacological treatments as required), insulin, metformin, glibenclamide (glyburide)) were selected by two authors and double checked for accuracy. Outcomes included large for gestational age, shoulder dystocia, neonatal hypoglycaemia, caesarean section and pre-eclampsia. We pooled data using random-effects meta-analyses and used Bayesian network meta-analysis to compare pharmacological treatments (ie, including treatments not directly compared within a trial).
RESULTS
Forty-two trials were included, the reporting of which was generally poor with unclear or high risk of bias. Packages of care varied in their composition and reduced the risk of most adverse perinatal outcomes compared with routine care (eg, large for gestational age: relative risk0.58 (95% CI 0.49 to 0.68; I=0%; trials 8; participants 3462). Network meta-analyses suggest that metformin had the highest probability of being the most effective treatment in reducing the risk of most outcomes compared with insulin or glibenclamide.
CONCLUSIONS
Evidence shows that packages of care are effective in reducing the risk of most adverse perinatal outcomes. However, trials often include few women, are poorly reported with unclear or high risk of bias and report few outcomes. The contribution of each treatment within the packages of care remains unclear. Large well-designed and well-conducted trials are urgently needed.
TRIAL REGISTRATION NUMBER
PROSPERO CRD42013004608.
Topics: Bayes Theorem; Cesarean Section; Diabetes, Gestational; Female; Glyburide; Humans; Hypoglycemic Agents; Insulin; Metformin; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic
PubMed: 28647726
DOI: 10.1136/bmjopen-2016-015557 -
The Cochrane Database of Systematic... Jun 2017Gestational diabetes mellitus (GDM) is associated with both short- and long-term complications for the mother and her baby. Exercise interventions may be useful in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Gestational diabetes mellitus (GDM) is associated with both short- and long-term complications for the mother and her baby. Exercise interventions may be useful in helping with glycaemic control and improve maternal and infant outcomes.The original review on Exercise for diabetic pregnant women has been split into two new review titles reflecting the role of exercise for pregnant women with gestational diabetes and for pregnant women with pre-existing diabetes. Exercise for pregnant women with gestational diabetes for improving maternal and fetal outcomes (this review) Exercise for pregnant women with pre-existing diabetes for improving maternal and fetal outcomes OBJECTIVES: To evaluate the effects of exercise interventions for improving maternal and fetal outcomes in women with GDM.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (27 August 2016), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (18th August 2016), and reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing an exercise intervention with standard care or another intervention in pregnant women diagnosed with gestational diabetes. Quasi-randomised and cross-over studies, and studies including women with pre-existing type 1 or type 2 diabetes were not eligible for inclusion.
DATA COLLECTION AND ANALYSIS
All selection of studies, assessment of trial quality and data extraction was conducted independently by two review authors. Data were checked for accuracy.
MAIN RESULTS
We included 11 randomised trials, involving 638 women. The overall risk of bias was judged to be unclear due to lack of methodological detail in the included studies.For the mother, there was no clear evidence of a difference between women in the exercise group and those in the control group for the risk of pre-eclampsia as the measure of hypertensive disorders of pregnancy (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.01 to 7.09; two RCTs, 48 women; low-quality evidence), birth by caesarean section (RR 0.86, 95% CI 0.63 to 1.16; five RCTs, 316 women; I = 0%; moderate-quality evidence), the risk of induction of labour (RR 1.38, 95% CI 0.71 to 2.68; one RCT, 40 women; low-quality evidence) or maternal body mass index at follow-up (postnatal weight retention or return to pre-pregnancy weight) (mean difference (MD) 0.11 kg/m, 95% CI -1.04 to 1.26; three RCTs, 254 women; I = 0%; high-quality evidence). Development of type 2 diabetes, perineal trauma/tearing and postnatal depression were not reported as outcomes in the included studies.For the infant/child/adult, a single small (n = 19) trial reported no perinatal mortality (stillbirth and neonatal mortality) events in either the exercise intervention or control group (low-quality evidence). There was no clear evidence of a difference between groups for a mortality and morbidity composite (variously defined by trials, e.g. perinatal or infant death, shoulder dystocia, bone fracture or nerve palsy) (RR 0.56, 95% CI 0.12 to 2.61; two RCTs, 169 infants; I = 0%; moderate-quality evidence) or neonatal hypoglycaemia (RR 2.00, 95% CI 0.20 to 20.04; one RCT, 34 infants; low-quality evidence). None of the included trials pre-specified large-for-gestational age, adiposity (neonatal/infant, childhood or adulthood), diabetes (childhood or adulthood) or neurosensory disability (neonatal/infant) as trial outcomes.Other maternal outcomes of interest: exercise interventions were associated with both reduced fasting blood glucose concentrations (average standardised mean difference (SMD) -0.59, 95% CI -1.07 to -0.11; four RCTs, 363 women; I = 73%; T = 0.19) and a reduced postprandial blood glucose concentration compared with control interventions (average SMD -0.85, 95% CI -1.15 to -0.55; three RCTs, 344 women; I = 34%; T = 0.03).
AUTHORS' CONCLUSIONS
Short- and long-term outcomes of interest for this review were poorly reported. Current evidence is confounded by the large variety of exercise interventions. There was insufficient high-quality evidence to be able to determine any differences between exercise and control groups for our outcomes of interest. For the woman, both fasting and postprandial blood glucose concentrations were reduced compared with the control groups. There are currently insufficient data for us to determine if there are also benefits for the infant. The quality of the evidence in this review ranged from high to low quality and the main reason for downgrading was for risk of bias and imprecision (wide CIs, low event rates and small sample size). Development of type 2 diabetes, perineal trauma/tearing, postnatal depression, large-for-gestational age, adiposity (neonate/infant, childhood or adulthood), diabetes (childhood or adulthood) or neurosensory disability (neonate/infant) were not reported as outcomes in the included studies.Further research is required comparing different types of exercise interventions with control groups or with another exercise intervention that reports on both the short- and long-term outcomes (for both the mother and infant/child) as listed in this review.
Topics: Adult; Body Mass Index; Cesarean Section; Diabetes, Gestational; Dystocia; Exercise Therapy; Female; Humans; Hypoglycemia; Infant; Infant, Newborn; Labor, Induced; Perinatal Mortality; Pre-Eclampsia; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 28639706
DOI: 10.1002/14651858.CD012202.pub2 -
Acta Obstetricia Et Gynecologica... Jul 2017The National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine have... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
The National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, and Society for Maternal-Fetal Medicine have emphasized the need to promote vaginal delivery and have offered recommendations to safely prevent primary cesarean delivery. However, there has been limited discussion regarding management of intravenous fluids and other aspects of labor management that may influence mode of delivery. Therefore the aim of our study was to determine whether an intravenous fluid rate of 250 vs. 125 mL/h is associated with a difference in cesarean delivery rate.
MATERIAL AND METHODS
Searches were performed in MEDLINE, OVID, Scopus, ClinicalTrials.gov, the PROSPERO International Prospective Register of Systematic Reviews, Embase, Web of Science, and the Cochrane Library for randomized controlled trials. We included all randomized controlled trials comparing intravenous fluid rates of 250 vs. 125 mL/h in nulliparous women in spontaneous labor at term with singleton pregnancies at ≥36 weeks. Studies were included regardless of the type of intravenous fluids used and regardless of whether oral intake was restricted during labor. Studies including multiparous women or women whose labor was induced were excluded. The primary outcome was the incidence of cesarean delivery. We planned to assess a subgroup analysis according to type of fluids used and according to restriction of oral fluid intake.
RESULTS
Seven trials including 1215 nulliparous women in spontaneous labor at term were analyzed; 593 (48.8%) in the 250 mL/h group, and 622 (51.2%) in the 125 mL/h group. Five studies used lactated Ringer's solution, one used normal saline in dextrose water, and in one study it was unclear which intravenous fluid was used. Women who received intravenous fluids at 250 mL/h had a significantly lower incidence of cesarean delivery for any indication (12.5 vs. 18.1%; RR 0.70, 95% CI 0.53-0.92; seven studies, 1215 participants; I = 0%) and for dystocia (4.9 vs. 7.7%; RR 0.60, 95% CI 0.38-0.97; five studies, 1093 participants; I = 18%), a significantly shorter mean duration of labor of about one hour (mean difference -64.38 min, 95% CI -121.88 to -6.88; six studies, 1155 participants; I = 83%) and a significantly shorter mean length of second stage of labor (mean difference -2.80 min, 95% CI -4.49 to -1.10; 899 participants; I = 22%) compared with those who received intravenous fluid at 125 mL/h. No differences were found in the other secondary outcomes. There were no maternal or perinatal deaths and only one woman, in the 125 mL/h group, developed pulmonary edema. The findings persisted regardless of the type of intravenous fluid used. No significant reduction in the incidence of cesarean delivery was demonstrated in women with unrestricted oral intake; however, this was limited to only two studies evaluating 254 women.
CONCLUSIONS
Our findings provide evidence that the duration of labor in low-risk nulliparous women may be shortened by a policy of intravenous fluids at a rate of 250 mL/h rather than 125 mL/h. A rate of 250 mL/h seems to be associated with a reduction in the incidence of cesarean delivery compared to 125 mL/h. The number needed to treat to prevent one cesarean delivery is 18 women. Our data support increased hydration among nulliparous women in labor when oral intake is restricted. Further study is needed regarding risks and benefits of increased hydration among women with unrestricted oral intake, those undergoing induction of labor, and those with medical comorbidities.
Topics: Cesarean Section; Female; Humans; Infusions, Intravenous; Isotonic Solutions; Labor, Obstetric; Parity; Pregnancy
PubMed: 28236651
DOI: 10.1111/aogs.13121 -
The Cochrane Database of Systematic... Feb 2017Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe,... (Review)
Review
BACKGROUND
Insulin requirements may change during pregnancy, and the optimal treatment for pre-existing diabetes is unclear. There are several insulin regimens (e.g. via syringe, pen) and types of insulin (e.g. fast-acting insulin, human insulin).
OBJECTIVES
To assess the effects of different insulin types and different insulin regimens in pregnant women with pre-existing type 1 or type 2 diabetes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 October 2016), ClinicalTrials.gov (17 October 2016), the WHO International Clinical Trials Registry Platform (ICTRP; 17 October 2016), and the reference lists of retrieved studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared different insulin types and regimens in pregnant women with pre-existing diabetes.We had planned to include cluster-RCTs, but none were identified. We excluded quasi-randomised controlled trials and cross-over trials. We included studies published in abstract form and contacted the authors for further details when applicable. Conference abstracts were superseded by full publications.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion, conducted data extraction, assessed risk of bias, and checked for accuracy. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
The findings in this review were based on very low-quality evidence, from single, small sample sized trial estimates, with wide confidence intervals (CI), some of which crossed the line of no effect; many of the prespecified outcomes were not reported. Therefore, they should be interpreted with caution. We included five trials that included 554 women and babies (four open-label, multi-centre, two-arm trials; one single centre, four-arm RCT). All five trials were at a high or unclear risk of bias due to lack of blinding, unclear methods of randomisation, and selective reporting of outcomes. Pooling of data from the trials was not possible, as each trial looked at a different comparison.1. One trial (N = 33 women) compared Lispro insulin with regular insulin and provided very low-quality evidence for the outcomes. There were seven episodes of pre-eclampsia in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (risk ratio (RR) 0.68, 95% CI 0.35 to 1.30). There were five caesarean sections in the Lispro group and nine in the regular insulin group, with no clear difference between the two groups (RR 0.59, 95% CI 0.25 to 1.39). There were no cases of fetal anomaly in the Lispro group and one in the regular insulin group, with no clear difference between the groups (RR 0.35, 95% CI 0.02 to 8.08). Macrosomia, perinatal deaths, episodes of birth trauma including shoulder dystocia, nerve palsy, and fracture, and the composite outcome measure of neonatal morbidity were not reported.2. One trial (N = 42 women) compared human insulin to animal insulin, and provided very low-quality evidence for the outcomes. There were no cases of macrosomia in the human insulin group and two in the animal insulin group, with no clear difference between the groups (RR 0.22, 95% CI 0.01 to 4.30). Perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy and fracture and the composite outcome measure of neonatal morbidity were not reported.3. One trial (N = 93 women) compared pre-mixed insulin (70 NPH/30 REG) to self-mixed, split-dose insulin and provided very low-quality evidence to support the outcomes. Two cases of macrosomia were reported in the pre-mixed insulin group and four in the self-mixed insulin group, with no clear difference between the two groups (RR 0.49, 95% CI 0.09 to 2.54). There were seven cases of caesarean section (for cephalo-pelvic disproportion) in the pre-mixed insulin group and 12 in the self-mixed insulin group, with no clear difference between groups (RR 0.57, 95% CI 0.25 to 1.32). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome measure of neonatal morbidity were not reported.4. In the same trial (N = 93 women), insulin injected with a Novolin pen was compared to insulin injected with a conventional needle (syringe), which provided very low-quality evidence to support the outcomes. There was one case of macrosomia in the pen group and five in the needle group, with no clear difference between the different insulin regimens (RR 0.21, 95% CI 0.03 to 1.76). There were five deliveries by caesarean section in the pen group compared with 14 in the needle group; women were less likely to deliver via caesarean section when insulin was injected with a pen compared to a conventional needle (RR 0.38, 95% CI 0.15 to 0.97). Perinatal death, pre-eclampsia, fetal anomaly, birth trauma including shoulder dystocia, nerve palsy, or fracture, and the composite outcome measure of neonatal morbidity were not reported.5. One trial (N = 223 women) comparing insulin Aspart with human insulin reported none of the review's primary outcomes: macrosomia, perinatal death, pre-eclampsia, caesarean section, fetal anomaly, birth trauma including shoulder dystocia. nerve palsy, or fracture, or the composite outcome measure of neonatal morbidity.6. One trial (N = 162 women) compared insulin Detemir with NPH insulin, and supported the outcomes with very low-quality evidence. There were three cases of major fetal anomalies in the insulin Detemir group and one in the NPH insulin group, with no clear difference between the groups (RR 3.15, 95% CI 0.33 to 29.67). Macrosomia, perinatal death, pre-eclampsia, caesarean section, birth trauma including shoulder dystocia, nerve palsy, or fracture and the composite outcome of neonatal morbidity were not reported.
AUTHORS' CONCLUSIONS
With limited evidence and no meta-analyses, as each trial looked at a different comparison, no firm conclusions could be made about different insulin types and regimens in pregnant women with pre-existing type 1 or 2 diabetes. Further research is warranted to determine who has an increased risk of adverse pregnancy outcome. This would include larger trials, incorporating adequate randomisation and blinding, and key outcomes that include macrosomia, pregnancy loss, pre-eclampsia, caesarean section, fetal anomalies, and birth trauma.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Detemir; Insulin Lispro; Pregnancy; Pregnancy Complications; Pregnancy in Diabetics
PubMed: 28156005
DOI: 10.1002/14651858.CD011880.pub2 -
Ultrasound in Obstetrics & Gynecology :... Aug 2017To compare the effectiveness of customized vs population-based growth charts for the prediction of adverse pregnancy outcomes. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To compare the effectiveness of customized vs population-based growth charts for the prediction of adverse pregnancy outcomes.
METHODS
MEDLINE, ClinicalTrials.gov and The Cochrane Library were searched up to 31 May 2016 to identify interventional and observational studies comparing adverse outcomes among large- (LGA) and small- (SGA) for-gestational-age neonates, when classified according to customized vs population-based growth charts. Perinatal mortality and admission to the neonatal intensive care unit (NICU) of both SGA and LGA neonates, intrauterine fetal demise (IUFD) and neonatal mortality of SGA neonates, and neonatal shoulder dystocia and hypoglycemia as well as maternal third- and fourth-degree perineal lacerations in LGA pregnancies were evaluated.
RESULTS
The electronic search identified 237 records that were examined based on title and abstract, of which 27 full-text articles were examined for eligibility. After excluding seven articles, 20 observational studies were included in a Bayesian meta-analysis. Neonates classified as SGA according to customized growth charts had higher risks of IUFD (odds ratio (OR), 7.8 (95% CI, 4.2-12.3)), neonatal death (OR, 3.5 (95% CI, 1.1-8.0)), perinatal death (OR, 5.8 (95% CI, 3.8-7.8)) and NICU admission (OR, 3.6 (95% CI, 2.0-5.5)) than did non-SGA cases. Neonates classified as SGA according to population-based growth charts also had increased risk for adverse outcomes, albeit the point estimates of the pooled ORs were smaller: IUFD (OR, 3.3 (95% CI, 1.9-5.0)), neonatal death (OR, 2.9 (95% CI, 1.2-4.5)), perinatal death (OR, 4.0 (95% CI, 2.8-5.1)) and NICU admission (OR, 2.4 (95% CI, 1.7-3.2)). For LGA vs non-LGA, there were no differences in pooled ORs for perinatal death, NICU admission, hypoglycemia and maternal third- and fourth-degree perineal lacerations when classified according to either the customized or the population-based approach. In contrast, both approaches indicated that LGA neonates are at increased risk for shoulder dystocia than are non-LGA ones (OR, 7.4 (95% CI, 4.9-9.8) using customized charts; OR, 8.0 (95% CI, 5.3-10.1) using population-based charts).
CONCLUSIONS
Both customized and population-based growth charts can identify SGA neonates at risk for adverse outcomes. Although the point estimates of the pooled ORs may differ for some outcomes, the overlapping CIs and lack of direct comparisons prevent conclusions from being drawn on the superiority of one method. Future clinical trials should compare directly the two approaches in the management of fetuses of abnormal size. Copyright © 2016 ISUOG. Published by John Wiley & Sons Ltd.
Topics: Bayes Theorem; Birth Weight; Female; Fetal Macrosomia; Growth Charts; Humans; Infant; Infant Mortality; Infant, Newborn; Infant, Small for Gestational Age; Pregnancy; Pregnancy Outcome
PubMed: 27935148
DOI: 10.1002/uog.17381 -
BMJ (Clinical Research Ed.) Sep 2016To assess the association between maternal glucose concentrations and adverse perinatal outcomes in women without gestational or existing diabetes and to determine... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
To assess the association between maternal glucose concentrations and adverse perinatal outcomes in women without gestational or existing diabetes and to determine whether clear thresholds for identifying women at risk of perinatal outcomes can be identified.
DESIGN
Systematic review and meta-analysis of prospective cohort studies and control arms of randomised trials.
DATA SOURCES
Databases including Medline and Embase were searched up to October 2014 and combined with individual participant data from two additional birth cohorts.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Studies including pregnant women with oral glucose tolerance (OGTT) or challenge (OGCT) test results, with data on at least one adverse perinatal outcome.
APPRAISAL AND DATA EXTRACTION
Glucose test results were extracted for OGCT (50 g) and OGTT (75 g and 100 g) at fasting and one and two hour post-load timings. Data were extracted on induction of labour; caesarean and instrumental delivery; pregnancy induced hypertension; pre-eclampsia; macrosomia; large for gestational age; preterm birth; birth injury; and neonatal hypoglycaemia. Risk of bias was assessed with a modified version of the critical appraisal skills programme and quality in prognostic studies tools.
RESULTS
25 reports from 23 published studies and two individual participant data cohorts were included, with up to 207 172 women (numbers varied by the test and outcome analysed in the meta-analyses). Overall most studies were judged as having a low risk of bias. There were positive linear associations with caesarean section, induction of labour, large for gestational age, macrosomia, and shoulder dystocia for all glucose exposures across the distribution of glucose concentrations. There was no clear evidence of a threshold effect. In general, associations were stronger for fasting concentration than for post-load concentration. For example, the odds ratios for large for gestational age per 1 mmol/L increase of fasting and two hour post-load glucose concentrations (after a 75 g OGTT) were 2.15 (95% confidence interval 1.60 to 2.91) and 1.20 (1.13 to 1.28), respectively. Heterogeneity was low between studies in all analyses.
CONCLUSIONS
This review and meta-analysis identified a large number of studies in various countries. There was a graded linear association between fasting and post-load glucose concentration across the whole glucose distribution and most adverse perinatal outcomes in women without pre-existing or gestational diabetes. The lack of a clear threshold at which risk increases means that decisions regarding thresholds for diagnosing gestational diabetes are somewhat arbitrary. Research should now investigate the clinical and cost-effectiveness of applying different glucose thresholds for diagnosis of gestational diabetes on perinatal and longer term outcomes.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42013004608.
Topics: Birth Weight; Diabetes, Gestational; Dystocia; Evidence-Based Medicine; Female; Fetal Macrosomia; Glucose Tolerance Test; Humans; Hyperglycemia; Infant, Newborn; Pregnancy; Pregnancy Outcome; Premature Birth; Randomized Controlled Trials as Topic; Risk Factors
PubMed: 27624087
DOI: 10.1136/bmj.i4694 -
Taiwanese Journal of Obstetrics &... Aug 2016This study aimed to systematically review the articles on factors affecting sexual function during menopause. Searching articles indexed in Pubmed, Science Direct,... (Review)
Review
This study aimed to systematically review the articles on factors affecting sexual function during menopause. Searching articles indexed in Pubmed, Science Direct, Iranmedex, EMBASE, Scopus, and Scientific Information Database databases, a total number of 42 studies published between 2003 and 2013 were selected. Age, estrogen deficiency, type of menopause, chronic medical problems, partner's sex problems, severity of menopause symptoms, dystocia history, and health status were the physical factors influencing sexual function of menopausal women. There were conflicting results regarding the amount of androgens, hormonal therapy, exercise/physical activity, and obstetric history. In the mental-emotional area, all studies confirmed the impact of depression and anxiety. Social factors, including smoking, alcohol consumption, the quality of relationship with husband, partner's loyalty, sexual knowledge, access to health care, a history of divorce or the death of a husband, living apart from a spouse, and a negative understanding of women's health were found to affect sexual function; however, there were conflicting results regarding the effects of education, occupation, socioeconomic status, marital duration, and frequency of sexual intercourse.
Topics: Age Factors; Anxiety; Depression; Female; Health Knowledge, Attitudes, Practice; Humans; Menopause; Middle Aged; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Sexual Partners; Spouses
PubMed: 27590367
DOI: 10.1016/j.tjog.2016.06.001 -
The Cochrane Database of Systematic... May 2016It has been brought to the authors' attention that there may be an error in the data (Analysis 1.9). This is currently under investigation, and a correction will be made... (Meta-Analysis)
Meta-Analysis Review
EDITORIAL NOTE
It has been brought to the authors' attention that there may be an error in the data (Analysis 1.9). This is currently under investigation, and a correction will be made if the data are found to be incorrect. Details can be found in the comments.
BACKGROUND
Women with a suspected large-for-dates fetus or a fetus with suspected macrosomia (birthweight greater than 4000 g) are at risk of operative birth or caesarean section. The baby is also at increased risk of shoulder dystocia and trauma, in particular fractures and brachial plexus injury. Induction of labour may reduce these risks by decreasing the birthweight, but may also lead to longer labours and an increased risk of caesarean section.
OBJECTIVES
To assess the effects of a policy of labour induction at or shortly before term (37 to 40 weeks) for suspected fetal macrosomia on the way of giving birth and maternal or perinatal morbidity.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2016), contacted trial authors and searched reference lists of retrieved studies.
SELECTION CRITERIA
Randomised trials of induction of labour for suspected fetal macrosomia.
DATA COLLECTION AND ANALYSIS
Review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We contacted study authors for additional information. For key outcomes the quality of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included four trials, involving 1190 women. It was not possible to blind women and staff to the intervention, but for other 'Risk of bias' domains these studies were assessed as being at low or unclear risk of bias.Compared to expectant management, there was no clear effect of induction of labour for suspected macrosomia on the risk of caesarean section (risk ratio (RR) 0.91, 95% confidence interval (CI) 0.76 to 1.09; 1190 women; four trials, moderate-quality evidence) or instrumental delivery (RR 0.86, 95% CI 0.65 to 1.13; 1190 women; four trials, low-quality evidence). Shoulder dystocia (RR 0.60, 95% CI 0.37 to 0.98; 1190 women; four trials, moderate-quality evidence), and fracture (any) (RR 0.20, 95% CI 0.05 to 0.79; 1190 women; four studies, high-quality evidence) were reduced in the induction of labour group. There were no clear differences between groups for brachial plexus injury (two events were reported in the control group in one trial, low-quality evidence). There was no strong evidence of any difference between groups for measures of neonatal asphyxia; low five-minute infant Apgar scores (less than seven) or low arterial cord blood pH (RR 1.51, 95% CI 0.25 to 9.02; 858 infants; two trials, low-quality evidence; and, RR 1.01, 95% CI 0.46 to 2.22; 818 infants; one trial, moderate-quality evidence, respectively). Mean birthweight was lower in the induction group, but there was considerable heterogeneity between studies for this outcome (mean difference (MD) -178.03 g, 95% CI -315.26 to -40.81; 1190 infants; four studies; I(2) = 89%). In one study with data for 818 women, third- and fourth-degree perineal tears were increased in the induction group (RR 3.70, 95% CI 1.04 to 13.17).For outcomes assessed using GRADE, we based our downgrading decisions on high risk of bias from lack of blinding and imprecision of effect estimates.
AUTHORS' CONCLUSIONS
Induction of labour for suspected fetal macrosomia has not been shown to alter the risk of brachial plexus injury, but the power of the included studies to show a difference for such a rare event is limited. Also antenatal estimates of fetal weight are often inaccurate so many women may be worried unnecessarily, and many inductions may not be needed. Nevertheless, induction of labour for suspected fetal macrosomia results in a lower mean birthweight, and fewer birth fractures and shoulder dystocia. The unexpected observation in the induction group of increased perineal damage, and the plausible, but of uncertain significance, observation of increased use of phototherapy, both in the largest trial, should also be kept in mind.Findings from trials included in the review suggest that to prevent one fracture it would be necessary to induce labour in 60 women. Since induction of labour does not appear to alter the rate of caesarean delivery or instrumental delivery, it is likely to be popular with many women. In settings where obstetricians can be reasonably confident about their scan assessment of fetal weight, the advantages and disadvantages of induction at or near term for fetuses suspected of being macrosomic should be discussed with parents.Although some parents and doctors may feel the evidence already justifies induction, others may justifiably disagree. Further trials of induction shortly before term for suspected fetal macrosomia are needed. Such trials should concentrate on refining the optimum gestation of induction, and improving the accuracy of the diagnosis of macrosomia.
Topics: Birth Weight; Brachial Plexus Neuropathies; Delivery, Obstetric; Dystocia; Female; Fetal Macrosomia; Humans; Labor, Induced; Obstetric Labor Complications; Pregnancy; Randomized Controlled Trials as Topic; Watchful Waiting
PubMed: 27208913
DOI: 10.1002/14651858.CD000938.pub2