Dick J. Bekedam

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

BackgroundMultiple 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/DesignWe 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.DiscussionThis 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 registrationCurrent Controlled Trials: NTR 1858

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 practice.

Cervical pessaries to prevent preterm birth in women with a multiple pregnancy : A per-protocol analysis of a randomized clinical trial

We recently showed that a cervical pessary prevents preterm birth and reduces poor neonatal outcomes in women with a twin pregnancy and a short cervix (<38 mm). The objective of this study was to evaluate the full potential treatment effect of the pessary in the whole group and in women with a short cervix.

Maternal temperature during labour

Objective  The aim of this study was to describe the variation of normal maternal temperature during labour.

Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial

Diabetes is associated with a high risk of adverse pregnancy outcomes. Optimal glycaemic control is fundamental and is traditionally monitored with self‐measured glucose profiles and periodic HbA1c measurements. We investigated the effectiveness of additional use of retrospective continuous glucose monitoring (CGM) in diabetic pregnancies.

Maternal Temperature During Labor

Although elevated maternal temperature is known to be associated with intrauterine infection, increased risk of neonatal infection, and the use of epidural analgesia for labor, the exact range of normal maternal temperature during labor is not well described. This prospective cohort study examined the variations of normal maternal temperature in laboring women at a gestational age >36 weeks. Maternal rectal temperatures were measured in all laboring women at the authors’ institutions every 2 to 3 hours from admission until the beginning of the second stage and at 1-hour intervals postpartum.Womenwere excluded if scheduled for a planned cesarean delivery, if they presented in labor at full cervical dilation, or if the fetus was breech or had a serious congenital anomaly. Patients were separated into 2 groups. The study group (abnormal labor group) had factors associated with elevated maternal temperature, that is, admission to the delivery room Z6 hours before delivery, meconium-stained amniotic fluid, epidural analgesia, induction or augmentation of labor, rupture of membranes Z18 hours before birth, Z5 vaginal examinations, and operative delivery. Women in the normal labor group presented at Z37 week gestation, had spontaneous onset of labor, rupture of membranes <18 hours before birth, clear amniotic fluid, normal labor progress without the need for augmentation, epidural analgesia, or antibiotics, and also spontaneously delivered a healthy infant in normal condition. Intrauterine infection was deemed present if temperature was Z381C or Z381C along with fetal or maternal tachycardia, meconium-stained amniotic fluid, or maternal white blood cell count Z16 10/L. Women with infections were treated with intravenous amoxicillin or gentamicin until delivery. Data on 3052 of 3358 women were complete enough for analysis. Normal labor occurred in 843 women and abnormal labor in 2209 in whom a diagnosis of intrauterine infection during labor was made in 84 (2.7%). The mean temperature during labor in all patients increased from 37.11C [2 standard deviation (2-SD) 0.71C; 95% confidence interval (CI), 36.5-37.71C] at the beginning of labor to 37.41C (SD 1.21C; CI 36.4-38.21C ) after 22 hours. In the women having a normal labor, the mean temperature was 37.11C (CI, 36.4-37.71C); in those having an abnormal labor, the temperature was equal to the normal labor group during the first 3 hours of labor but then increased thereafter. For all measurements before delivery, mean temperature readings were similar for the normal and abnormal groups. Only 2% of women with normal labor had a temperature during labor higher than the upper 2-SD limit, whereas this occurred in 8% of those in the abnormal labor group. The regression coefficient for 2-SD was significantly higher in the abnormal labor group (0.0301C/h vs. the normal labor group 0.0081C/h). About 91% of those with an intrauterine infection diagnosis had a temperature above the 2-SD limit. Multivariate analysis demonstrated that a temperature higher than the 2-SD limit was associated with epidural analgesia [odds ratio (OR), 3.1; CI, 1.9-5.2], in hospital Z6 hours before delivery (OR, 3.1; CI, 1.9-5.4), meconium-stained fluid (OR, 2.0; CI, 1.2-3.1), and rupture of membranes Z18 hours before delivery (OR, 1.9; CI, 1.1-3.1). Temperature remained stable in the normal-labor group but slowly increased throughout labor in those with an abnormal labor. A circadian pattern was not found at the upper 2-SD limit and time of day is not relevant for classifying normal versus elevated temperature.