Amnioinfusion in preterm premature rupture of membranes (AMIPROM): a randomised controlled trial of amnioinfusion versus expectant management in very early preterm premature rupture of membranes – a pilot study

Autor: Devender Roberts, Sarah Vause, William Martin, Pauline Green, Stephen Walkinshaw, Leanne Bricker, Caroline Beardsmore, Ben NJ Shaw, Andrew McKay, Gaynor Skotny, Paula Williamson, Zarko Alfirevic
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Zdroj: Health Technology Assessment, Vol 18, Iss 21 (2014)
Druh dokumentu: article
ISSN: 1366-5278
2046-4924
DOI: 10.3310/hta18210
Popis: Background: Fetal survival is severely compromised when the amniotic membrane ruptures between 16 and 24 weeks of pregnancy. Reduced amniotic fluid levels are associated with poor lung development, whereas adequate levels lead to better perinatal outcomes. Restoring amniotic fluid by means of ultrasound-guided amnioinfusion (AI) may be of benefit in improving perinatal and long-term outcomes in children of pregnancies with this condition. Objective: The AI in preterm premature rupture of membranes (AMIPROM) pilot study was conducted to assess the feasibility of recruitment, the methods for conduct and the retention through to long-term follow-up of participants with very early rupture of amniotic membranes (between 16 and 24 weeks of pregnancy). It was also performed to assess outcomes and collect data to inform a larger, more definitive, clinical trial. Design: A prospective, non-blinded randomised controlled trial. A computer-generated random sequence using a 1 : 1 ratio was used. Randomisation was stratified for pregnancies in which the amniotic membrane ruptured between 16+0 and 19+6 weeks’ gestation and 20+0 and 24+0 weeks’ gestation. The randomisation sequence was generated in blocks of four. Telephone randomisation and intention-to-treat analysis were used. Setting: 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. Participants: Women with confirmed preterm prelabour rupture of membranes between 16+0 and 24+0 weeks’ gestation. Women with multiple pregnancies, resultant fetal abnormalities or obstetric indication for immediate delivery were excluded. Interventions: Participants were randomly allocated to either serial weekly transabdominal AI or expectant management (Exp) until 37 weeks of pregnancy, if the deepest pool of amniotic fluid was
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