Objective
To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.
Design
Randomised non‐inferiority trial.
Setting
...Thirty‐seven Dutch university and general hospitals.
Population
Women with acute anaemia (haemoglobin 4.8–7.9 g/dl 3.0–4.9 mmol/l 12–24 hours postpartum) without severe anaemic symptoms or severe comorbidities.
Methods
Women were allocated to RBC transfusion or non‐intervention.
Main outcome measures
Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4–20; 20 represents maximal fatigue). Non‐inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health‐related quality of life and physical complications. Health‐related quality of life questionnaires were completed at five time‐points until 6 weeks postpartum.
Results
In all, 521 women were randomised to non‐intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1–1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3–1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non‐intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable.
Conclusions
Statistically, non‐inferiority could not be demonstrated as the confidence interval crossed the non‐inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.
Double-layer compared to single-layer closure of the uterus after a caesarean section (CS) leads to a thicker myometrial layer at the site of the CS scar, also called residual myometrium thickness ...(RMT). It possibly decreases the development of a niche, which is an interruption of the myometrium at the site of the uterine scar. Thin RMT and a niche are associated with gynaecological symptoms, obstetric complications in a subsequent pregnancy and delivery and possibly with subfertility.
Women undergoing a first CS regardless of the gestational age will be asked to participate in this multicentre, double blinded randomised controlled trial (RCT). They will be randomised to single-layer closure or double-layer closure of the uterine incision. Single-layer closure (control group) is performed with a continuous running, unlocked suture, with or without endometrial saving technique. Double-layer closure (intervention group) is performed with the first layer in a continuous unlocked suture including the endometrial layer and the second layer is also continuous unlocked and imbricates the first. The primary outcome is the reported number of days with postmenstrual spotting during one menstrual cycle nine months after CS. Secondary outcomes include surgical data, ultrasound evaluation at three months, menstrual pattern, dysmenorrhea, quality of life, and sexual function at nine months. Structured transvaginal ultrasound (TVUS) evaluation is performed to assess the uterine scar and if necessary saline infusion sonohysterography (SIS) or gel instillation sonohysterography (GIS) will be added to the examination. Women and ultrasound examiners will be blinded for allocation. Reproductive outcomes at three years follow-up including fertility, mode of delivery and complications in subsequent deliveries will be studied as well. Analyses will be performed by intention to treat. 2290 women have to be randomised to show a reduction of 15% in the mean number of spotting days. Additionally, a cost-effectiveness analysis will be performed from a societal perspective.
This RCT will provide insight in the outcomes of single- compared to double-layer closure technique after CS, including postmenstrual spotting and subfertility in relation to niche development measured by ultrasound.
Dutch Trial Register ( NTR5480 ). Registered 29 October 2015.
•Lifestyle intervention after complicated pregnancy is feasible.•Lifestyle intervention after complicated pregnancy results in weight loss at 13 months postpartum.•Clinicians should discuss lifestyle ...intervention at the regular visit 6 weeks after complicated pregnancy.•Randomized controlled trials in varied populations are needed to confirm efficacy and durability of effects.
To evaluate the feasibility and effectiveness of a postpartum lifestyle intervention after pregnancies complicated by preeclampsia, fetal growth restriction (FGR) and/or gestational diabetes mellitus (GDM) to improve maternal risk factors for future cardiometabolic disease.
Women following a complicated pregnancy were included six months postpartum in this specific pre-post controlled designed study. It has been conducted in one tertiary and three secondary care hospitals (intervention group) and one secondary care hospital (control group). The program consisted of a computer-tailored health education program combined with three individual counselling sessions during seven months. Primary outcome measures were the proportion of eligible women and weight change during the intervention.
Two hundred and six women were willing to participate. The proportion of eligible women who complied with the intervention was 23%. Major barrier was lack of time.
Adjusted weight change attributed to lifestyle intervention was −1.9 kg (95%-CI −4.3 to −0.3). Further changes were BMI (-0.9 kg/m2 (95%-CI −1.4 to −0.3)), waist-to-hip ratio (−0.04 cm/cm (95%-CI −0.06 to −0.03)), blood pressure medication use (19% (95%-CI 9% to 28%)), HOMA2-score (59 %S (95%-CI 18 to 99)) and total fat intake (−2.9 gr (95%-CI −4.6 to −1.2)).
The results support feasibility and effectiveness of a lifestyle intervention after complicated pregnancies to improve maternal cardiometabolic risk factors. Further randomized controlled studies are needed with longer follow-up to evaluate durability. In the meantime, we suggest health care professionals to offer lifestyle interventions to women after complicated pregnancies.
Objective
To assess the economic consequences of labour induction with Foley catheter compared to prostaglandin E2 gel.
Design
Economic evaluation alongside a randomised controlled trial.
Setting
...Obstetric departments of one university and 11 teaching hospitals in the Netherlands.
Population
Women scheduled for labour induction with a singleton pregnancy in cephalic presentation at term, intact membranes and an unfavourable cervix; and without previous caesarean section.
Methods
Cost‐effectiveness analysis from a hospital perspective.
Main outcome measures
We estimated direct medical costs associated with healthcare utilisation from randomisation to 6 weeks postpartum. For caesarean section rate, and maternal and neonatal morbidity we calculated the incremental cost‐effectiveness ratios, which represent the costs to prevent one of these adverse outcomes.
Results
Mean costs per woman in the Foley catheter group (n = 411) and in the prostaglandin E2 gel group (n = 408), were €3297 versus €3075, respectively, with an average difference of €222 (95% confidence interval −€157 to €633). In the Foley catheter group we observed higher costs due to longer labour ward occupation and less cost related to induction material and neonatal admissions. Foley catheter induction showed a comparable caesarean section rate compared with prostaglandin induction, therefore the incremental cost‐effectiveness ratio was not informative. Foley induction resulted in fewer neonatal admissions (incremental cost‐effectiveness ratio €2708) and asphyxia/postpartum haemorrhage (incremental cost‐effectiveness ratios €5257) compared with prostaglandin induction.
Conclusions
Foley catheter and prostaglandin E2 labour induction generate comparable costs.
Please cite this paper as: van Oostwaard M, Langenveld J, Bijloo R, Wong K, Scholten I, Loix S, Hukkelhoven C, Vergouwe Y, Papatsonis D, Mol B, Ganzevoort W. Prediction of recurrence of hypertensive ...disorders of pregnancy between 34 and 37 weeks of gestation: a retrospective cohort study. BJOG 2012;119:840–847.
Objective To assess the recurrence risk of late‐preterm hypertensive disease of pregnancy, and to determine whether potential risk factors are predictive.
Design Retrospective cohort study.
Setting Three secondary and three tertiary care hospitals in the Netherlands.
Population We identified women with a hypertensive disorder in the index pregnancy and delivery at 34–37 weeks of gestation, between January 2000 and December 2002.
Methods Data were extracted from medical files and women were approached for additional information on subsequent pregnancies. An adverse outcome was defined as the recurrence of a hypertensive disorder in the next subsequent pregnancy.
Main outcome measures Absolute risk of recurrence and a prediction model containing demographic and clinical factors predictive for adverse outcome.
Results We identified 425 women who matched the criteria, of whom 351 could be contacted. Of these women, 189 (54%) had had a subsequent pregnancy. Hypertensive disorders recurred in 96 (51%, 95% CI 43–58%) women, of whom 17 (9%, 95% CI 5–14%) delivered again before 37 weeks of gestation. Chronic hypertension and maternal age were the strongest predictors for recurrence. Women undergoing recurrence had a nine‐fold chance of developing chronic hypertension (37% versus 6%, OR 8.7, 95% CI 3.3–23).
Conclusions Women with hypertensive disorders and late‐preterm delivery have a 50% chance of recurrence, but only a 9% chance of recurrence resulting in delivery before 37 weeks of gestation. Women with chronic hypertension are prone to develop recurrence, and women with a recurrence more often developed chronic hypertension.
Preterm birth is a major contributor to perinatal mortality and morbidity and affects approximately six to seven per cent of births in developed countries. Tocolytics are drugs used to suppress ...uterine contractions. The most widely tested tocolytics are betamimetics. Although they have been shown to delay delivery, betamimetics have not been shown to improve perinatal outcome, and they have a high frequency of unpleasant and even fatal maternal side effects. There is growing interest in calcium channel blockers as a potentially effective and well tolerated form of tocolysis.
To assess the effects on maternal, fetal and neonatal outcomes of calcium channel blockers, administered as a tocolytic agent, to women in preterm labour.
We searched the Cochrane Pregnancy and Childbirth Group's specialised register of controlled trials, the Cochrane Controlled Trials Register (February 2002), MEDLINE, EMBASE, and Current Contents. We also contacted recognised experts and cross referenced relevant material.
All published and unpublished randomised trials in which calcium channel blockers were used for tocolysis for women in labour between 20 and 36 weeks gestation.
Standard methods of the Cochrane Collaboration and the Cochrane Pregnancy and Childbirth Group were used. Evaluation of methodological quality and trial data extraction were undertaken independently by three authors. Additional information was sought to enable assessment of methodology and conduct of intention-to-treat analyses. Meta-analysis was conducted assessing the effects of calcium channel blockers compared with any other tocolytic agent. Results are presented using relative risk for categorical data and weighted mean difference for continuous data.
Eleven randomised controlled trials involving 870 women were included. When compared with any other tocolytic agent (mainly betamimetics), calcium channel blockers reduced the number of women giving birth within 48 hours (relative risk (RR) 0.73; 95% confidence interval (CI) 0.54, 0.98) and within seven days (RR 0.76; 95% CI 0.59, 0.99). Calcium channel blockers also reduced the requirement for women to have treatment ceased for adverse drug reaction (RR 0.15; 95% CI 0.06, 0.43), the frequency of neonatal respiratory distress syndrome (RR 0.64; 95% CI 0.45, 0.91) and neonatal jaundice (RR 0.73; 95% CI 0.57, 0.93).
When tocolysis is indicated for women in preterm labour, calcium channel blockers are preferable to betamimetic agents. Further research should address the effects of different dosage regimens and formulations of nifedipine on maternal and neonatal outcomes.
To compare the efficacy of nifedipine with ritodrine in the management of preterm labor.
One hundred eighty-five singleton pregnancies with preterm labor were assigned randomly to either ritodrine ...intravenously (
n = 90) or nifedipine orally (
n = 95). The principal outcome assessed was delay of delivery.
Ritodrine was discontinued in 12 patients because of severe maternal side effects, and their results were excluded from further analysis. More women in the ritodrine group delivered within 24 hours (22 versus 11,
P = .006), within 48 hours (29 versus 21,
P = .03), within 1 week (45 versus 36,
P = .009), and within 2 weeks (52 versus 43,
P = .005) compared with those receiving nifedipine. There were significantly fewer maternal side effects in the nifedipine group. Apgar scores and umbilical artery and vein pHs were similar in both groups. The number of admissions to the neonatal intensive care unit (NICU) in the nifedipine group was significantly lower than in the ritodrine group (68.4 versus 82.1%,
P = .04).
Nifedipine in comparison with ritodrine in the management of preterm labor is significantly associated with a longer postponement of delivery, fewer maternal side effects, and fewer admissions to the NICU.
Abstract Background Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent miscarriage (RM) and other pregnancy complications such as preterm birth. It is unclear if ...treatment with levothyroxine improves pregnancy outcome. Aim The aim of this study is to determine the effect of levothyroxine administration on live birth rate in euthyroid TPO-Ab positive women with recurrent miscarriage. Methods/design We will perform a multicenter, placebo controlled randomized trial in euthyroid women with recurrent miscarriage and TPO-Ab. Recurrent miscarriage is defined as two or more miscarriages before the 20th week of gestation. The primary outcome is live birth, defined as the birth of a living fetus beyond 24 weeks of gestation. Secondary outcomes are ongoing pregnancy at 12 weeks, miscarriage, preterm birth, (serious) adverse events, time to pregnancy and survival at 28 days of neonatal life. The analysis will be performed according to the intention to treat principle. We need to randomize 240 women (120 per group) to demonstrate an improvement in live birth rate from 55% in the placebo group to 75% in the levothyroxine treatment group. This trial is a registered trial (NTR 3364, March 2012). Here we discuss the rationale and design of the T4-LIFE study, an international multicenter randomized, double blind placebo controlled, clinical trial aimed to assess the effectiveness of levothyroxine in women with recurrent miscarriage and TPO-Ab.
Preterm birth, defined as birth before 37 completed weeks, is the single most important cause of perinatal mortality and morbidity in high-income countries. Oxytocin receptor antagonists have been ...proposed as effective tocolytic agents for women in preterm labour to postpone the birth, with fewer side-effects than other tocolytic agents.
To assess the effects on maternal, fetal and neonatal outcomes of tocolysis with oxytocin receptor antagonists for women with preterm labour compared with placebo or no intervention and compared with any other tocolytic agent.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (September 2004), CENTRAL (The Cochrane Library, Issue 3, 2004), MEDLINE (1965 to June 2004), EMBASE (1988 to June 2004).
Randomised trials of oxytocin receptor antagonists for tocolysis in the management of women in labour between 20 and 36 weeks' gestation.
Two authors independently evaluated methodological quality and extracted trial data. We sought additional information from trial authors.
Six trials (1695 women) were included. Compared with placebo, atosiban did not reduce incidence of preterm birth or improve neonatal outcome. In one trial (583 infants), atosiban was associated with an increase in infant deaths at 12 months of age compared with placebo (relative risk (RR) 6.15; 95% confidence intervals (CI) 1.39 to 27.22). However, this trial randomised significantly more women to atosiban before 26 weeks' gestation. Use of atosiban resulted in lower infant birthweight (weighted mean difference -138.31 gm; 95% CI -248.76 to -27.86) and more maternal adverse drug reactions (RR 4.02; 95% CI 2.05 to 7.85, 2 trials, 613 women).Compared with betamimetics, atosiban increased the numbers of infants born under 1500 gm (RR 1.96; 95% CI 1.15 to 3.35, 2 trials, 575 infants). Atosiban was associated with fewer maternal drug reactions requiring treatment cessation (RR 0.04; 95% CI 0.02 to 0.11, number needed to treat 6; 95% CI 5 to 7, 4 trials, 1035 women).
This review failed to demonstrate the superiority of atosiban over betamimetics or placebo in terms of tocolytic efficacy or infant outcomes. The finding of an increase in infant deaths in one placebo controlled trial warrants caution. A recent Cochrane review suggests that calcium channel blockers (mainly nifedipine) are associated with better neonatal outcome and fewer maternal side-effects than betamimetics. However, a randomised comparison of nifedipine with placebo is not available. Further well-designed randomised controlled trials of tocolytic therapy are needed. Such trials should incorporate a placebo arm.
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