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Ppromexil III

 

Very early preterm prelabour rupture of membranes (PPROM). Expectant management or Amnioninfusion for improving perinatal outcomes.


Go to the Ppromexil III website

 

Objective
This study will answer the question if (repeated) abdominal amnioninfusion after very early 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.

Study design
Multicenter randomised controlled clinical trial

Study population
The trial will study 56 pregnant patients with PPROM after 16 and before 24 weeks of gestational age. The randomised clinical trial will be performed in perinatal centres that are collaborating in the Dutch obstetric consortium.

Intervention
Random allocation to (repeated) abdominal amnioninfusion (intervention) or expectant management (control).

 

Inclusion criteria

- Singleton pregnancy.

- PPROM at a gestational age between 16 and 24 wks.

- PPROM diagnosed at least 72 hours ago, but no longer than 21 days ago.

- Oligohydramnios (Single deepest pocket <=2 cm).

 

Exclusion criteria

- signs of premature uterine contractions.

- signs of cervical incompetence.

- signs of intra uterine infection.

- pregnancy complication (hypertension, HELLP syndrome, preeclampsia or other) in which there is a need for termination of pregnancy.

- Placental or major structural fetal anomalies.

- Women whose child has signs of fetal distress (abnormal biophysical profile).

 

 

Outcome measures
Primary outcome is perinatal mortality.

Secondary outcomes are: Lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge  from NICU,  neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, succesfull amnioninfusion, placental abruption, cord prolaps, chorioamnionitis, fetal trauma due to puncture.

Power/data analysis
The study will be evaluated according to intention to treat.  To show a decrease in perinatal mortality from 70% till 35%, we need to randomise two groups of 28 women (two sided test, beta 0.2 at alpha 0.05).


Time schedule
Total study time 36 months.

Projectleaders
Dr. B.W. Mol, Gynaecologist, AMC, Amsterdam

Dr. E. Pajkrt, Gynaecologist, AMC, Amsterdam

Dr, H.C.J. Scheepers, Maastricht UMC


Methodology
Sander van Kuijk


Contact

Drs. Stijn van Teeffelen,

Maastricht University Medical Centre

Dep. Obstetrics/Gynaecology

P.O. Box 5800

6202 AZ Maastricht 

Tel. 043-3874768 (# 7088)

Email: PPROMEXIL3@studies-obsgyn.nl