Perinatal death in a term fetal growth restriction randomized controlled trial:the paradox of prior risk and consent

BACKGROUND: The disproportionate intrauterine growth intervention trial at term was an intention to treat analysis and compared labor induction with expectant monitoring in pregnancies complicated by fetal growth restriction at term and showed equivalence for neonatal outcomes. OBJECTIVE: To evaluate trial participation bias and to examine the generalizability of the results of an obstetrical randomized trial. STUDY DESIGN: We used data from participants and nonparticipants of a randomized controlled trial-the disproportionate intrauterine growth intervention trial at term (n=1116) -to perform a secondary analysis. This study compared induction of labor and expectant management in women with term growth restriction. Data were collected in the same manner for both groups. Baseline characteristics and neonatal and maternal outcomes were compared. The primary outcome was a composite measure of adverse neonatal outcome. Secondary outcomes were delivery by cesarean delivery and instrumental vaginal delivery; length of stay in the neonatal intensive care, neonatal ward, and the maternal hospital; and maternal morbidity. RESULTS: Nonparticipants were older, had a lower body mass index, had a higher level of education, smoked less, and preferred expectant management. The time between study inclusion and labor onset was shorter in participants than in nonparticipants. Notably, 4 perinatal deaths occurred among nonparticipants and none among participants. Among nonparticipants, there were more children born with a birthweight below the third centile. The nonparticipants who had expectant management were monitored less frequently than the participants in both the intervention and the expectant arm. CONCLUSION: We found less favorable outcomes and more perinatal deaths in nonparticipants. Protocol-driven management, differences between participants and nonparticipants, or the fact that nonparticipants had a preference for expectant management might explain the findings

Maternal health-related quality of life after induction of labor or expectant monitoring in pregnancy complicated by intrauterine growth retardation beyond 36 weeks

Objective: Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time. Methods: Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model wa

Development and measurement of guidelines-based quality indicators of caesarean section care in the Netherlands: A RAND-modified delphi procedure and retrospective medical chart review

Background There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. Method Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. Results The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adh

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

Dilemma in Timing of Delivery in a Patient with an Acute Myocardial Infarction

Introduction. Acute myocardial infarction (AMI) in a pregnant woman is rare. When occurring, AMI is a major cause of maternal and neonatal death. By presenting the following case we describe the dilemma concerning the timing of delivery. Case. A 36-year-old, multiparous women, at 35 6/7 weeks of gestation, suffered from an AMI due to an acute blockage of the left anterior descending artery (LAD). This was treated by angiographic thrombosuction and biodegradable stent placement. Within 5 hours after this procedure, a cesarean section (CS) was performed because of a nonreassuring fetal condition. A healthy son with an Apgar score of 9/10 was born. The patient’s postoperative course was complicated by a big wound hematoma, a hemoglobin drop, and heart failure. Discussion. In case of AMI during pregnancy, the cardiological management has absolute priority. The obstetrical management is not outlined. In a nonreassuring fetal condition, delivery is indicated after stabilization of the mother. However, delivery after recent AMI and angiography will bring new risks of cardiologic stress and bleeding complications. The limited literature available tends to an expectant obstetrical management, but this case emphasizes the difficulty of waiting in suspected fetal distress

Dilemma in Timing of Delivery in a Patient with an Acute Myocardial Infarction

Introduction. Acute myocardial infarction (AMI) in a pregnant woman is rare. When occurring, AMI is a major cause of maternal and neonatal death. By presenting the following case we describe the dilemma concerning the timing of delivery. Case. A 36-year-old, multiparous women, at 35 6/7 weeks of gestation, suffered from an AMI due to an acute blockage of the left anterior descending artery (LAD). This was treated by angiographic thrombosuction and biodegradable stent placement. Within 5 hours after this procedure, a cesarean section (CS) was performed because of a nonreassuring fetal condition. A healthy son with an Apgar score of 9/10 was born. The patient’s postoperative course was complicated by a big wound hematoma, a hemoglobin drop, and heart failure. Discussion. In case of AMI during pregnancy, the cardiological management has absolute priority. The obstetrical management is not outlined. In a nonreassuring fetal condition, delivery is indicated after stabilization of the mother. However, delivery after recent AMI and angiography will bring new risks of cardiologic stress and bleeding complications. The limited literature available tends to an expectant obstetrical management, but this case emphasizes the difficulty of waiting in suspected fetal distress

Vaginale baring veilig voor tweeling vanaf 32 weken?

Compared with other countries, the elective caesarean section rate for twins is relatively low in the Netherlands. Worldwide, there is an increasing trend toward performing more elective caesarean sections for women with a twin pregnancy at term, be it for twins with the first child in breech or in cephalic presentation. The results of the 'Twin Birth Study' indicate that a planned caesarean section does not improve outcome as compared with planned vaginal birth for twins with the first child in cephalic position beyond 32 weeks gestation. During the study, an experienced obstetrician was present during planned vaginal delivery and there was a possibility of performing a secondary caesarean section within 30 minutes. This study provides an additional argument to guarantee the aforementioned conditions in all hospitals where women plan to deliver their twins vaginally. However, the definition of an experienced obstetrician is subject to debat