Perinatal death in a term fetal growth restriction randomized controlled trial
| Autor: | Wessel Ganzevoort, Ben W.J. Mol, Friso M.C. Delemarre, Maria G. van Pampus, Anneke Kwee, Saskia le Cessie, Frans J.M.E. Roumen, Sanne J. Gordijn, Kitty W. M. Bloemenkamp, Kim E. Boers, Sicco A. Scherjon, Henk A. Bremer, Jim G Thornton, Jan M. M. van Lith, Linda van Wyk |
|---|---|
| Přispěvatelé: | Obstetrics and Gynaecology, APH - Quality of Care, Amsterdam Reproduction & Development (AR&D), APH - Digital Health, Reproductive Origins of Adult Health and Disease (ROAHD) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Perinatal Death medicine.medical_treatment Intrauterine growth restriction law.invention Randomized controlled trial Pregnancy law Intensive care medicine Humans Mass index Labor Induced Child Watchful Waiting Fetal Growth Retardation Informed Consent Intention-to-treat analysis Participation bias Vaginal delivery Obstetrics business.industry Infant Newborn General Medicine medicine.disease Labor induction Female business |
| Zdroj: | American journal of obstetrics & gynecology MFM, 2(4). Elsevier BV American journal of obstetrics & gynecology MFM, 2(4):100239 |
| ISSN: | 2589-9333 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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