Amnioinfusion in very early preterm prelabor rupture of membranes (AMIPROM): pregnancy, neonatal and maternal outcomes in a randomized controlled pilot study

ABSTRACT Objective To assess short‐ and long‐term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. Methods This was a prospective non‐blinded randomized...

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Bibliographic Details
Published in:Ultrasound in obstetrics & gynecology 2014-05, Vol.43 (5), p.490-499
Main Authors: Roberts, D., Vause, S., Martin, W., Green, P., Walkinshaw, S., Bricker, L., Beardsmore, C., Shaw, N., McKay, A., Skotny, G., Williamson, P., Alfirevic, Z.
Format: Article
Language:English
Subjects:
Adult
AMIPROM
amnioinfusion
Amniotic Fluid
Female
Fetal Membranes, Premature Rupture - therapy
Gestational Age
Humans
Infant
Infant, Newborn
Infusions, Parenteral - methods
Isotonic Solutions - administration & dosage
Lung - embryology
Lung - physiopathology
Pilot Projects
Pregnancy
Pregnancy Outcome
Prospective Studies
Respiratory Function Tests - methods
Respiratory Sounds
Surveys and Questionnaires
Survival Analysis
very early preterm prelabor rupture of membranes
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Summary:ABSTRACT Objective To assess short‐ and long‐term outcomes of pregnant women with very early rupture of membranes randomized to serial amnioinfusion or expectant management, and to collect data to inform a larger, more definitive clinical trial. Methods This was a prospective non‐blinded randomized controlled trial with randomization stratified for pregnancies in which the membranes ruptured between 16 + 0 and 19 + 6 weeks' gestation and 20 + 0 and 23 + 6 weeks' gestation to minimize the risk of random imbalance in gestational age distribution between randomized groups. Intention‐to‐treat analysis was used. The study was conducted in four UK hospital‐based fetal medicine units (Liverpool Women's NHS Trust, St Mary's Hospital Manchester, Birmingham Women's NHS Foundation Trust and Wirral University Hospitals Trust). The participants were women with confirmed preterm prelabor rupture of membranes at 16 + 0 to 24 + 0 weeks' gestation. Women with multiple pregnancy, fetal abnormality or obstetric indication for immediate delivery were excluded. Participants were randomly allocated to either serial weekly transabdominal amnioinfusions if the deepest pool of amniotic fluid was 
ISSN:0960-7692
1469-0705
DOI:10.1002/uog.13258