Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

Contains fulltext : 79491.pdf (publisher's version ) (Open Access)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.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. DISCUSSION: This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials: NTR 1858

Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial

Contains fulltext : 53183.pdf ( ) (Open Access)BACKGROUND: Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to 15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates. METHODS/DESIGN: Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%. DISCUSSION: This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications. TRIAL REGISTRATION: The protocol is registered in the clinical trial register number ISRCTN08132825

Disproportionate Intrauterine Growth Intervention Trial At Term: DIGITAT

Contains fulltext : 65628.pdf ( ) (Open Access)BACKGROUND: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. METHODS/DESIGN: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm. DISCUSSION: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. TRIAL REGISTRATION: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217

Cervical pessaries for the prevention of preterm birth: a systematic review

Introduction. Reduction of preterm birth is a major goal in obstetric care. We performed a systematic review of randomized controlled trials and cohort studies on the effectiveness of the cervical pessary to prevent preterm birth. Methods. We searched the electronic databases of MEDLINE and Embase from inception until April 2012 to identify studies investigating treatment with a cervical pessary to prevent preterm birth. We constructed two-by-two tables for delivery before 28, 34, and 37 weeks of gestation and calculated relative risks (RRs) with 95% confidence intervals. Results. The search revealed 103 potentially eligible abstracts of which six cohort studies and four randomized controlled trials (RCTs) investigated the effectiveness of the pessary. One RCT (n = 380) demonstrated a lower delivery rate prior to 34 weeks (RR 0.24; 95% CI 0.13-0.43) in the pessary group, while another RCT (n = 108) showed no positive effect of pessary for delivery before 34 weeks (RR 1.73; 95% CI 0.43-6.88). Two older quasi randomized studies and cohort studies indicated potential effect of the pessary. Conclusions. Available randomized and nonrandomized studies indicate potential effectiveness of a cervical pessary in the prevention of preterm birth. More randomized clinical trials are needed before this device can be used in clinical practic

Male predominance in fetal distress during labor

OBJECTIVE: The purpose of this study was to assess the association between fetal sex and the occurrence of fetal distress during labor. STUDY DESIGN: This was a prospective cohort study that incorporated data about 423,033 singleton pregnancies from the national perinatal database for secondary obstetric care in The Netherlands. All singleton pregnancies on record that were delivered under the responsibility of obstetricians in The Netherlands between January 1, 1990, and December 31, 1994, were analyzed. Data about fetal sex, gestational age at delivery, birth weight, fetal distress during labor, mode of delivery, signs of asphyxia at birth, and perinatal death were collected. The associations between sex and the occurrence of operative delivery for fetal distress, low 5-minute Apgar score (score, 0-3), and perinatal death were evaluated by logistic regression analysis. RESULTS: Male fetuses are at increased risk for fetal distress during labor, for low Apgar scores, and for perinatal death. After adjustment for fetal birth weight and gestational age at delivery, the odds ratios were 1.48, 1.27, and 1.27, respectively. All three associations were highly statistically significant (P <.0001). CONCLUSION: Male fetuses are at increased risk during labor and deliver

Haemolytic anaemia after nitrofurantoin treatment in a pregnant woman with G6PD deficiency

We present a normotensive, pregnant woman with severe haemolytic anaemia in the third trimester of pregnancy. Owing to normal platelet count diagnoses other than HELLP syndrome were considered and investigated. The patient was treated with nitrofurantoin 3 weeks before presentation and she turned out to have a deficiency of glucose-6-phosphate dehydrogenase. After treatment with blood transfusion, vitamin B12 and folic acid the patient recovered completely. Caesarean delivery was performed because of maternal hypertension and fetal distress at 33 weeks' gestation

Pessary Placement in the Prevention of Preterm Birth in Multiple Pregnancies : A Propensity Score Analysis

Preterm birth is the major contributor to perinatal mortality and serious neonatal morbidity, and approximately 30% of all patients admitted to a neonatal intensive care unit in the Netherlands are born from a multiple pregnancy. In asymptomatic women with a multiple pregnancy and short cervix, prophylactic use of a cervical pessary might reduce preterm birth. The aim of this study is to assess the possible treatment effects of pessary use in pregnancy duration and for poor perinatal outcome. This cohort study was performed between December 2012 and September 2014 in 44 hospitals in the Netherlands. Cervical length was measured between 16 and 22 weeks of gestation. When cervical length was below 38 mm, women were offered a cervical pessary. The pessaries were removed at 36 weeks of gestation or in case of premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or severe patient discomfort. The course of pregnancy, including perinatal outcome in these women, was compared with the outcome of women from the placebo group of the AMPHIA trial (ISRCTN40512715) (historical cohort). Propensity score matching with replacement was used to create comparable baseline characteristics between both populations. The study included 63 women in the pessary group and 56 women as control subjects. Propensity score matching generated 57 women in the intervention group matched to 57 women (31 unique) in the control group. Gestational age at delivery was comparable between both groups (hazard ratio, 0.96; 95% confidence interval [CI], 0.46–1.46), as well as their delivery rates before 28, 32, and 37 weeks (RR, 0.68 [95% CI, 0.21–2.18]; RR, 0.54 [95% CI, 0.21–1.41]; and RR, 1.22 [95% CI, 0.47–3.15]), respectively. There was no difference in composite perinatal outcome (RR, 1.36 [95% CI, 0.53–3.51]) and perinatal mortality (RR, 0.89 [95% CI, 0.24–3.38]) either. Results of this cohort study with propensity score analysis could not confirm the positive effect of pessary therapy in the prevention of preterm birth in asymptomatic multiple pregnancies with a short cervix in this propensity score analysis. With ongoing studies on this subject, the definite answer whether pessaries are effective in the prevention of preterm birth will come. If effective, evaluation of implementation, similar to this study, is still necessary