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Caroline A Crowther - One of the best experts on this subject based on the ideXlab platform.
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specialised antenatal clinics for women with a Multiple Pregnancy for improving maternal and infant outcomes
Cochrane Database of Systematic Reviews, 2015Co-Authors: Jodie M Dodd, Therese Dowswell, Caroline A CrowtherAbstract:Background Regular antenatal care for women with a Multiple Pregnancy is accepted practice, and while most women have an increase in the number of antenatal visits, there is no consensus as to what constitutes optimal care. 'Specialised' antenatal clinics have been advocated as a way of improving outcomes for women and their infants. Objectives To assess, using the best available evidence, the benefits and harms of 'specialised' antenatal clinics compared with 'standard' antenatal care for women with a Multiple Pregnancy. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. Selection criteria All published, unpublished, and ongoing randomised controlled trials with reported data that compared outcomes in mothers and babies with a Multiple Pregnancy who received antenatal care specifically designed for women with a Multiple Pregnancy (as defined by the trial authors) with outcomes in controls who received 'standard' antenatal care (as defined by the trial authors). Data collection and analysis Two of the review authors independently assessed trials for inclusion and trial quality. Both review authors extracted data. Data were checked for accuracy. We graded the quality of the evidence using GRADEpro software. Main results Findings were based on the results of a single study with some design limitations. Data were available from one study involving 162 women with a Multiple Pregnancy. For the only reported primary outcome, perinatal mortality, we are uncertain whether specialised antenatal clinics makes any difference compared to standard care (risk ratio (RR) 1.02; 95% confidence interval (CI) 0.26 to 4.03; 324 infants, very low quality evidence). Women receiving specialised antenatal care were significantly more likely to birth by caesarean section (RR 1.38; 95% CI 1.06 to 1.81; 162 women, moderate quality evidence). Data were not reported in the study on the following primary outcomes: small-for-gestational age, very preterm birth or maternal death. There were no differences identified between specialised antenatal care and standard care for other secondary outcomes examined: postnatal depression (RR 0.48; 95% CI 0.19 to 1.20; 133 women, very low quality evidence), breastfeeding (RR 0.63; 95% CI 0.24 to 1.68; 123 women, very low quality evidence), stillbirth (RR 0.68; 0.12 to 4.04) or neonatal death (RR 2.05; 95% CI 0.19 to 22.39) (324 infants). Authors' conclusions There is currently limited information available from randomised controlled trials to assess the role of 'specialised' antenatal clinics for women with a Multiple Pregnancy compared with 'standard' antenatal care in improving maternal and infant health outcomes. The value of 'specialised' Multiple Pregnancy clinics in improving health outcomes for women and their infants requires evaluation in appropriately powered and designed randomised controlled trials.
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hospitalisation and bed rest for Multiple Pregnancy
Cochrane Database of Systematic Reviews, 2010Co-Authors: Caroline A Crowther, Shanshan HanAbstract:BACKGROUND Bed rest used to be widely advised for women with a Multiple Pregnancy. OBJECTIVES The objective was to assess the effect of bed rest in hospital for women with a Multiple Pregnancy for prevention of preterm birth and other fetal, neonatal and maternal outcomes. SEARCH STRATEGY The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled Trials Register and reference lists of relevant articles were searched. Date of last search: August 2000. SELECTION CRITERIA Randomised trials which compare outcomes in women with a Multiple Pregnancy and their babies who were offered bed rest in hospital with women only admitted to hospital if complications occurred. DATA COLLECTION AND ANALYSIS Assessment for inclusion and methodological quality of the trials was done by the reviewer. Data were extracted by the reviewer and double entered. All eligible trials were included in the initial analysis. Prespecified sensitivity analyses have been carried out to evaluate the effect of trial quality, the effects of hospitalisation for bed rest in women with an uncomplicated twin Pregnancy, in women with a triplet Pregnancy and in women with a twin Pregnancy complicated by cervical effacement and dilatation prior to labour. MAIN RESULTS Six trials were included which involved over 600 women and 1400 babies. (1) Analyses of all trials. Routine bed rest in hospital for Multiple Pregnancy did not reduce the risk of preterm birth, or perinatal mortality. There was a trend to a decreased number of low birth weight infants born to women in the routinely hospitalised group, which became significant when the trial using alternate allocation was excluded (odds ratio (OR) 0.79; 95% confidence interval (CI) 0.63-0.99). No differences were seen in the number of very low birth weight infants. No support for the policy was found in other neonatal outcomes. No information is available on developmental outcomes for infants in any of the trials. Women's views about the care they received were reported rarely. (2) Analyses of hospitalisation for bed rest in women with an uncomplicated twin Pregnancy. The risk of preterm birth was not reduced. Indeed significantly more women gave birth very preterm (< 34 weeks gestation) (OR 1.84; 95% CI 1.01-3.34). No differences were seen in perinatal mortality, or in other neonatal outcomes. Women receiving hospitalisation for bed rest had a decreased risk of developing hypertension (OR 0.55; 95% CI 0.32-0.97), although this effect was no longer apparent when the trial using alternate allocation was excluded. (3) Analyses of hospitalisation for bed rest in women with a triplet Pregnancy. Most of the comparisons made between the hospitalised and control groups suggest beneficial treatment effects from routine hospitalisation for bed rest. However all the differences observed between the experimental and control groups were compatible with chance variation. (4) Analyses of hospitalisation for bed rest in women with a twin Pregnancy complicated by cervical effacement and dilatation prior to labour. No differences were seen in the risk of preterm birth, perinatal mortality, fetal growth or in other neonatal outcomes. REVIEWER'S CONCLUSIONS There is currently not enough evidence to support a policy of routine hospitalisation for bed rest in Multiple Pregnancy. No reduction in the risk of preterm birth or perinatal death is evident, although there is a suggestion that fetal growth is improved. For women with an uncomplicated twin Pregnancy the results of this review suggest that it may be harmful in that the risk of very preterm birth is increased. Until further evidence is available to the contrary, the policy cannot be recommended for routine clinical practice.
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Evidence-based care of women with a Multiple Pregnancy
Best practice & research. Clinical obstetrics & gynaecology, 2004Co-Authors: Jodie M Dodd, Caroline A CrowtherAbstract:Women with a Multiple Pregnancy face greater risks for themselves and their infants than women pregnant with one child. Pre-Pregnancy care should focus on avoiding Multiple Pregnancy. Early prenatal care centres on determining chorionicity and screening for fetal anomalies, with later care focusing on the presentation, prediction and management of preterm birth, and intrauterine growth restriction. The optimal timing and mode of birth are the focus of current multicentre, randomised, controlled trials. However, the data from such trials on care for women with a Multiple Pregnancy are limited. Many areas of care require better-quality information, including when using assisted reproductive techniques, the optimal number of embryos to be transferred, care after the diagnosis of chorionicity, and the benefits of specialised Multiple Pregnancy clinics. Better-quality information is required to inform clinical practice for women with complications of Multiple Pregnancy, including monoamniotic twin Pregnancy, treatment of twin-to-twin transfusion syndrome, and care following single intrauterine fetal death.
Jodie M Dodd - One of the best experts on this subject based on the ideXlab platform.
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prenatal administration of progestogens for preventing spontaneous preterm birth in women with a Multiple Pregnancy
Cochrane Database of Systematic Reviews, 2017Co-Authors: Jodie M Dodd, Therese Dowswell, Rosalie M Grivell, Cecelia M Obrien, Andrea R DeussenAbstract:BACKGROUND Multiple Pregnancy is a strong risk factor for preterm birth, and more than 50% of women with a twin Pregnancy will give birth prior to 37 weeks' gestation. Infants born preterm are recognised to be at increased risk of many adverse health outcomes, contributing to more than half of overall perinatal mortality. Progesterone is produced naturally in the body and has a role in maintaining Pregnancy, although it is not clear whether administering progestogens to women with Multiple Pregnancy at high risk of early birth is effective and safe. Since publication of this new review in Issue 10, 2017, we have now moved one study (El-Refaie 2016) from included to studies awaiting classification, pending clarification about the study data. OBJECTIVES To assess the benefits and harms of progesterone administration for the prevention of preterm birth in women with a Multiple Pregnancy. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2016) and reference lists of retrieved studies. SELECTION CRITERIA We included randomised controlled trials examining the administration of a progestogen by any route for the prevention of preterm birth in women with Multiple Pregnancy. We did not include quasi-randomised or cross-over studies. DATA COLLECTION AND ANALYSIS Two review authors independently assessed reports identified by the search for eligibility, extracted data, assessed risk of bias and graded the quality of the evidence. MAIN RESULTS We included 16 trials, which all compared either vaginal or intramuscular (IM) progesterone with a placebo or no treatment, and involved a total of 4548 women. The risk of bias for the majority of included studies was low, with the exception of three studies that had inadequate blinding, or significant loss to follow-up or both, or were not reported well enough for us to make a judgement. We graded the evidence low to high quality, with downgrading for statistical heterogeneity, design limitations in some of the studies contributing data, and imprecision of the effect estimate. 1 IM progesterone versus no treatment or placebo More women delivered at less than 34 weeks' gestation in the IM progesterone group compared with placebo (risk ratio (RR) 1.54, 95% confidence interval (CI) 1.06 to 2.26; women = 399; studies = 2; low-quality evidence). Although the incidence of perinatal death in the progesterone group was higher, there was considerable uncertainty around the effect estimate and high heterogeneity between studies (average RR 1.45, 95% CI 0.60 to 3.51; infants = 3089; studies = 6; I2 = 71%; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (RR 1.05, 95% CI 0.98 to 1.13; women = 2010; studies = 5; high-quality evidence); preterm birth less than 28 weeks (RR 1.08, 95% CI 0.75 to 1.55; women = 1920; studies = 5; moderate-quality evidence); infant birthweight less than 2500 g (RR 0.99, 95% CI 0.90 to 1.08; infants = 4071; studies = 5; I2 = 76%, moderate-quality evidence)). No childhood outcomes were reported in the trials. 2 Vaginal progesterone versus no treatment or placebo by dose There were no clear group differences in incidence of preterm birth before 34 weeks (average RR 0.90, 95% CI 0.66 to 1.23; women = 1503; studies = 5; I2 = 36%; low-quality evidence). Although fewer births before 34 weeks appeared to occur in the progesterone group, the CIs crossed the line of no effect. Incidence of perinatal death was higher in the progesterone group, although there was considerable uncertainty in the effect estimate and the quality of the evidence was low for this outcome (RR 1.23, 95% CI 0.74 to 2.06; infants = 2287; studies = 3; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (average RR 0.97, 95% CI 0.89 to 1.06; women = 1597; studies = 6; moderate-quality evidence); preterm birth less than 28 weeks (RR 1.53, 95% CI 0.79 to 2.97; women = 1345; studies = 3; low-quality evidence); infant birthweight less than 2500 g (average RR 0.95, 95% CI 0.84 to 1.07; infants = 2640; studies = 3; I2 = 66%, moderate-quality evidence)). No childhood outcomes were reported in the trials. For secondary outcomes, there were no clear group differences found in any of the other maternal outcomes except for caesarean section, where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group, although the difference between groups was not large (8%) (RR 0.92, 95% CI 0.86 to 0.98; women = 1919; studies = 5; I2 = 0%). There were no clear group differences found in any of the infant outcomes except for mechanical ventilation, which was required by fewer infants whose mothers had received the vaginal progesterone (RR 0.70, 95% CI 0.52 to 0.94; infants = 2695; studies = 4). AUTHORS' CONCLUSIONS Overall, for women with a Multiple Pregnancy, the administration of progesterone (either IM or vaginal) does not appear to be associated with a reduction in risk of preterm birth or improved neonatal outcomes. Future research could focus on a comprehensive individual participant data meta-analysis including all of the available data relating to both IM and vaginal progesterone administration in women with a Multiple Pregnancy, before considering the need to conduct trials in subgroups of high-risk women (for example, women with a Multiple Pregnancy and a short cervical length identified on ultrasound).
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specialised antenatal clinics for women with a Multiple Pregnancy for improving maternal and infant outcomes
Cochrane Database of Systematic Reviews, 2015Co-Authors: Jodie M Dodd, Therese Dowswell, Caroline A CrowtherAbstract:Background Regular antenatal care for women with a Multiple Pregnancy is accepted practice, and while most women have an increase in the number of antenatal visits, there is no consensus as to what constitutes optimal care. 'Specialised' antenatal clinics have been advocated as a way of improving outcomes for women and their infants. Objectives To assess, using the best available evidence, the benefits and harms of 'specialised' antenatal clinics compared with 'standard' antenatal care for women with a Multiple Pregnancy. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies. Selection criteria All published, unpublished, and ongoing randomised controlled trials with reported data that compared outcomes in mothers and babies with a Multiple Pregnancy who received antenatal care specifically designed for women with a Multiple Pregnancy (as defined by the trial authors) with outcomes in controls who received 'standard' antenatal care (as defined by the trial authors). Data collection and analysis Two of the review authors independently assessed trials for inclusion and trial quality. Both review authors extracted data. Data were checked for accuracy. We graded the quality of the evidence using GRADEpro software. Main results Findings were based on the results of a single study with some design limitations. Data were available from one study involving 162 women with a Multiple Pregnancy. For the only reported primary outcome, perinatal mortality, we are uncertain whether specialised antenatal clinics makes any difference compared to standard care (risk ratio (RR) 1.02; 95% confidence interval (CI) 0.26 to 4.03; 324 infants, very low quality evidence). Women receiving specialised antenatal care were significantly more likely to birth by caesarean section (RR 1.38; 95% CI 1.06 to 1.81; 162 women, moderate quality evidence). Data were not reported in the study on the following primary outcomes: small-for-gestational age, very preterm birth or maternal death. There were no differences identified between specialised antenatal care and standard care for other secondary outcomes examined: postnatal depression (RR 0.48; 95% CI 0.19 to 1.20; 133 women, very low quality evidence), breastfeeding (RR 0.63; 95% CI 0.24 to 1.68; 123 women, very low quality evidence), stillbirth (RR 0.68; 0.12 to 4.04) or neonatal death (RR 2.05; 95% CI 0.19 to 22.39) (324 infants). Authors' conclusions There is currently limited information available from randomised controlled trials to assess the role of 'specialised' antenatal clinics for women with a Multiple Pregnancy compared with 'standard' antenatal care in improving maternal and infant health outcomes. The value of 'specialised' Multiple Pregnancy clinics in improving health outcomes for women and their infants requires evaluation in appropriately powered and designed randomised controlled trials.
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Evidence-based care of women with a Multiple Pregnancy
Best practice & research. Clinical obstetrics & gynaecology, 2004Co-Authors: Jodie M Dodd, Caroline A CrowtherAbstract:Women with a Multiple Pregnancy face greater risks for themselves and their infants than women pregnant with one child. Pre-Pregnancy care should focus on avoiding Multiple Pregnancy. Early prenatal care centres on determining chorionicity and screening for fetal anomalies, with later care focusing on the presentation, prediction and management of preterm birth, and intrauterine growth restriction. The optimal timing and mode of birth are the focus of current multicentre, randomised, controlled trials. However, the data from such trials on care for women with a Multiple Pregnancy are limited. Many areas of care require better-quality information, including when using assisted reproductive techniques, the optimal number of embryos to be transferred, care after the diagnosis of chorionicity, and the benefits of specialised Multiple Pregnancy clinics. Better-quality information is required to inform clinical practice for women with complications of Multiple Pregnancy, including monoamniotic twin Pregnancy, treatment of twin-to-twin transfusion syndrome, and care following single intrauterine fetal death.
Marc E A Spaanderman - One of the best experts on this subject based on the ideXlab platform.
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pessaries in Multiple Pregnancy as a prevention of preterm birth the protwin trial
BMC Pregnancy and Childbirth, 2009Co-Authors: Maud A Hegeman, Kitty W M Bloemenkamp, Dick J Bekedam, Anneke Kwee, Dimitri N M Papatsonis, Joris A M Van Der Post, Hubertina C J Scheepers, Christine Willekes, Johannes J Duvekot, Marc E A SpaandermanAbstract:Background: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. Methods/Design: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in Multiple Pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.
Maud A Hegeman - One of the best experts on this subject based on the ideXlab platform.
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cervical pessaries for prevention of preterm birth in women with a Multiple Pregnancy protwin a multicentre open label randomised controlled trial
Obstetrical & Gynecological Survey, 2014Co-Authors: Sophie Liem, Ewoud Schuit, Maud A Hegeman, Joke M J Bais, Karin De Boer, Kitty W M Bloemenkamp, Jozien T J Brons, Hans Duvekot, Bas Nij Bijvank, Maureen T M FranssenAbstract:Women with Multiple gestations often deliver at less than 37 weeks, increasing the risks of perinatal morbidity and mortality. Treatment with a pessary might prevent preterm birth by changing the inclination of the cervical canal and preventing premature dilatation of the cervix, rupture of the membranes, and deterioration or loss of the cervical mucous plug. This multicenter, open-label, randomized controlled trial at 40 hospitals was performed to determine whether a cervical pessary could prevent poor perinatal outcomes in parturients with a Multiple Pregnancy. At 12 to 20 weeks' gestation, patients were assigned to the pessary or control group; cervical length was measured at 16 to 22 weeks. Women in the study group received an Arabin pessary at 16 to 20 weeks, which was removed in week 36 or in case of preterm premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or patient discomfort. Obstetric care was otherwise similar in the 2 groups. The primary outcome was a composite of poor perinatal outcomes, including stillbirth, preventricular leukomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and neonatal death within 6 weeks after the anticipated term date. Secondary outcomes were time to delivery, preterm birth at less than 32 and less than 37 weeks, days in the neonatal intensive care unit, days of maternal admission for preterm labor, and maternal morbidity. A total of 401 of 403 women in the pessary group and 407 of 410 in the control group completed the study. Five women in the pessary group had a surgical cerclage; 1 patient died, and the others delivered at 21.6 to 36.7 weeks, with 3 having poor perinatal outcomes. No patients in the control group had a cerclage. Vaginal discharge occurred in 104 women (26%) in the pessary group and in none of the controls. The pessary was removed from 57 women (14%) at less than 28 weeks and from 22 women (5%) at 28 to 32 weeks; 7 and 13, respectively, delivered within 48 hours of removal. At 32 to 36 weeks, the pessary was removed from 107 women; 70 delivered within 48 hours. The most common reasons for pessary removal in these women were preterm premature rupture of the membranes, vaginal bleeding, contractions, and induction of labor. The composite poor perinatal outcome occurred in 53 women (13%) and 55 women (14%) in the pessary and control groups, respectively (relative risk (RR), 0.98; 95% confidence interval, 0.69-1.39). Ten stillbirths (2%) occurred in each group. The other conditions within the composite outcome did not differ between the 2 groups. In the pessary and control groups, 16 and 18 infants, respectively, died before discharge. The groups were similar in median gestational age at delivery; frequencies of delivery at less than 28, less than 32, and less than 37 weeks; and frequency and length of neonatal intensive care unit admission. In the women with a cervical length of less than 25th percentile ( <38 mm), the pessary significantly reduced the frequency of poor perinatal outcomes and very preterm delivery. A cervical pessary does not necessarily prevent poor perinatal outcomes or preterm birth in all women with a Multiple gestation. Although the pessary had a positive effect in women with a twin Pregnancy and a short cervix, these results should be confirmed in additional prospective studies. The safety and low cost of the pessary should be considered when counseling a parturient with a Multiple Pregnancy and short cervix
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cervical pessaries for prevention of preterm birth in women with a Multiple Pregnancy protwin a multicentre open label randomised controlled trial
The Lancet, 2013Co-Authors: Sophie Liem, Ewoud Schuit, Maud A Hegeman, Joke M J Bais, Karin De Boer, Kitty W M Bloemenkamp, Jozien T J Brons, Hans Duvekot, Bas Nij Bijvank, Maureen T M FranssenAbstract:Summary Background In women with a Multiple Pregnancy, spontaneous preterm delivery is the leading cause of perinatal morbidity and mortality. Interventions to reduce preterm birth in these women have not been successful. We assessed whether a cervical pessary could effectively prevent poor perinatal outcomes. Methods We undertook a multicentre, open-label randomised controlled trial in 40 hospitals in the Netherlands. We randomly assigned women with a Multiple Pregnancy between 12 and 20 weeks' gestation (1:1) to pessary or control groups, using a web-based application with a computer-generated list with random block sizes of two to four, stratified by hospital. Participants and investigators were aware of group allocation. For women in the pessary group, a midwife or obstetrician inserted a cervical pessary between 16 and 20 weeks' gestation. Women in the control group did not receive the pessary, but otherwise received similar obstetrical care to those in the pessary group. The primary outcome was a composite of poor perinatal outcome: stillbirth, periventricular leucomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular haemorrhage, necrotising enterocolitis, proven sepsis, and neonatal death. Analyses were by modified intention to treat. This trial is registered in the Dutch trial registry, number NTR1858. Findings Between Sept 21, 2009, and March 9, 2012, 813 women underwent randomisation, of whom 808 were analysed (401 in the pessary group; 407 in the control group). At least one child of 53 women (13%) in the pessary group had poor perinatal outcome, compared with 55 (14%) in the control group (relative risk 0·98, 95% CI 0·69–1·39). Interpretation In unselected women with a Multiple Pregnancy, prophylactic use of a cervical pessary does not reduce poor perinatal outcome. Funding The Netherlands Organisation for Health Research and Development.
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pessaries in Multiple Pregnancy as a prevention of preterm birth the protwin trial
BMC Pregnancy and Childbirth, 2009Co-Authors: Maud A Hegeman, Kitty W M Bloemenkamp, Dick J Bekedam, Anneke Kwee, Dimitri N M Papatsonis, Joris A M Van Der Post, Hubertina C J Scheepers, Christine Willekes, Johannes J Duvekot, Marc E A SpaandermanAbstract:Background: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. Methods/Design: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in Multiple Pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.
Andrea R Deussen - One of the best experts on this subject based on the ideXlab platform.
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prenatal administration of progestogens for preventing spontaneous preterm birth in women with a Multiple Pregnancy
Cochrane Database of Systematic Reviews, 2017Co-Authors: Jodie M Dodd, Therese Dowswell, Rosalie M Grivell, Cecelia M Obrien, Andrea R DeussenAbstract:BACKGROUND Multiple Pregnancy is a strong risk factor for preterm birth, and more than 50% of women with a twin Pregnancy will give birth prior to 37 weeks' gestation. Infants born preterm are recognised to be at increased risk of many adverse health outcomes, contributing to more than half of overall perinatal mortality. Progesterone is produced naturally in the body and has a role in maintaining Pregnancy, although it is not clear whether administering progestogens to women with Multiple Pregnancy at high risk of early birth is effective and safe. Since publication of this new review in Issue 10, 2017, we have now moved one study (El-Refaie 2016) from included to studies awaiting classification, pending clarification about the study data. OBJECTIVES To assess the benefits and harms of progesterone administration for the prevention of preterm birth in women with a Multiple Pregnancy. SEARCH METHODS We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2016) and reference lists of retrieved studies. SELECTION CRITERIA We included randomised controlled trials examining the administration of a progestogen by any route for the prevention of preterm birth in women with Multiple Pregnancy. We did not include quasi-randomised or cross-over studies. DATA COLLECTION AND ANALYSIS Two review authors independently assessed reports identified by the search for eligibility, extracted data, assessed risk of bias and graded the quality of the evidence. MAIN RESULTS We included 16 trials, which all compared either vaginal or intramuscular (IM) progesterone with a placebo or no treatment, and involved a total of 4548 women. The risk of bias for the majority of included studies was low, with the exception of three studies that had inadequate blinding, or significant loss to follow-up or both, or were not reported well enough for us to make a judgement. We graded the evidence low to high quality, with downgrading for statistical heterogeneity, design limitations in some of the studies contributing data, and imprecision of the effect estimate. 1 IM progesterone versus no treatment or placebo More women delivered at less than 34 weeks' gestation in the IM progesterone group compared with placebo (risk ratio (RR) 1.54, 95% confidence interval (CI) 1.06 to 2.26; women = 399; studies = 2; low-quality evidence). Although the incidence of perinatal death in the progesterone group was higher, there was considerable uncertainty around the effect estimate and high heterogeneity between studies (average RR 1.45, 95% CI 0.60 to 3.51; infants = 3089; studies = 6; I2 = 71%; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (RR 1.05, 95% CI 0.98 to 1.13; women = 2010; studies = 5; high-quality evidence); preterm birth less than 28 weeks (RR 1.08, 95% CI 0.75 to 1.55; women = 1920; studies = 5; moderate-quality evidence); infant birthweight less than 2500 g (RR 0.99, 95% CI 0.90 to 1.08; infants = 4071; studies = 5; I2 = 76%, moderate-quality evidence)). No childhood outcomes were reported in the trials. 2 Vaginal progesterone versus no treatment or placebo by dose There were no clear group differences in incidence of preterm birth before 34 weeks (average RR 0.90, 95% CI 0.66 to 1.23; women = 1503; studies = 5; I2 = 36%; low-quality evidence). Although fewer births before 34 weeks appeared to occur in the progesterone group, the CIs crossed the line of no effect. Incidence of perinatal death was higher in the progesterone group, although there was considerable uncertainty in the effect estimate and the quality of the evidence was low for this outcome (RR 1.23, 95% CI 0.74 to 2.06; infants = 2287; studies = 3; low-quality evidence). No studies reported maternal mortality or major neurodevelopmental disability at childhood follow-up. There were no clear group differences found in any of the other maternal or infant outcomes (preterm birth less than 37 weeks (average RR 0.97, 95% CI 0.89 to 1.06; women = 1597; studies = 6; moderate-quality evidence); preterm birth less than 28 weeks (RR 1.53, 95% CI 0.79 to 2.97; women = 1345; studies = 3; low-quality evidence); infant birthweight less than 2500 g (average RR 0.95, 95% CI 0.84 to 1.07; infants = 2640; studies = 3; I2 = 66%, moderate-quality evidence)). No childhood outcomes were reported in the trials. For secondary outcomes, there were no clear group differences found in any of the other maternal outcomes except for caesarean section, where women who received vaginal progesterone did not have as many caesarean sections as those in the placebo group, although the difference between groups was not large (8%) (RR 0.92, 95% CI 0.86 to 0.98; women = 1919; studies = 5; I2 = 0%). There were no clear group differences found in any of the infant outcomes except for mechanical ventilation, which was required by fewer infants whose mothers had received the vaginal progesterone (RR 0.70, 95% CI 0.52 to 0.94; infants = 2695; studies = 4). AUTHORS' CONCLUSIONS Overall, for women with a Multiple Pregnancy, the administration of progesterone (either IM or vaginal) does not appear to be associated with a reduction in risk of preterm birth or improved neonatal outcomes. Future research could focus on a comprehensive individual participant data meta-analysis including all of the available data relating to both IM and vaginal progesterone administration in women with a Multiple Pregnancy, before considering the need to conduct trials in subgroups of high-risk women (for example, women with a Multiple Pregnancy and a short cervical length identified on ultrasound).
