Midtrimester preterm prelabour rupture of membranes (PPROM). Expectant management or Amnioninfusion for improving perinatal outcomes. (PPROMEXIL-III)

Geplaatst op

Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are prone to neonatal pulmonary hypoplasia. Perinatal mortality after this complication is high.

Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioninfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome in general. In this multicenter RCT, outcome is compared for amnioninfusion vs standard care in women with a singleton pregnancy complicated by oligohydramnios secondary to PPROM at a gestational age between 16 and 24 weeks.

Doel

This study will answer the question whether (repeated) abdominal amnioninfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure.

Vraagstelling/hypothese

Does (repeated) abdominal amnioninfusion after midtrimester PPROM with associated oligohydramnios improve perinatal survival.

Relevantie

Preterm prelabour rupture of membranes (PPROM) before or near the limit of viability is associated with high perinatal morbidity and mortality. Respiratory complications are frequent after periviable PPROM, as well as sepsis, intraventricular haemorraghe, retinopathy and necrotizing enterocolitis. Among respiratory complications pulmonary hypoplasia is an important cause of death. Other respiratory complications consist of pneumonia, infant respiratory distress syndrome (IRDS) and bronchopulmonary dysplasia (BPD).
Pregnancies complicated by midtrimester PPROM are associated with high immediate and long-term costs. These are caused by extended maternal hospital admissions, increased incidence of premature delivery, and frequent neonatal complications hereafter requiring NICU-admission.
Amnioninfusion might improve fetal outcome by preventing pulmonary hypoplasia, by preventing neurological complications, increasing time to delivery interval, and improving fetal biophysical profile through prevention of umbilical cord compression. It might also prevent fetal deformity.

Begeleider(s)

Dr. E. Pajkrt

Uitvoerder(s)

Drs. A.S.P. van Teeffelen

Partners

Het onderzoeksconsortium Verloskunde, Gynaecologie, Fertiliteit,
Neonatologie, Gynaecologische Oncologie en Urogynaecologie

Website: www.studies-obsgyn.nl/ppromexil3

Contactpersonen

Drs. A.S.P. van Teeffelen

Periode

Begindatum: juni 2012
Einddatum: juni 2015

Data worden naar verwachting binnenkort (2017) aangeboden ter publicatie.


Publicaties

van Teeffelen AS, van der Ham DP, Willekes C, Al Nasiry S, Nijhuis JG, van Kuijk S, Schuyt E, Mulder TL, Franssen MT, Oepkes D, Jansen FA, Woiski MD, Bekker MN, Bax CJ, Porath MM, de Laat MW, Mol BW, Pajkrt E. Midtrimester preterm prelabour rupture of membranes (PPROM): expectant management or amnioinfusion for improving
perinatal outcomes (PPROMEXIL – III trial). BMC Pregnancy Childbirth. 2014 Apr 4;14:128. doi: 10.1186/1471-2393-14-128.



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