PPROMEXIL

Inleiden van de bevalling versus afwachten bij vrouwen met vroegtijdig gebroken vliezen tussen 34 en 37 weken zwangerschapsduur

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Problem:
Preterm pre labour rupture of the membranes (PPROM) is an importantclini-cal problem and a dilemma for the obstetric gynaecologist. On onehand, awaiting spontaneous labour may lead to an increase in infectiousdisease for both mother and child, whereas on the other hand inductionof labour leads to preterm birth with an increase in neonatal morbidity(e.g. respiratory dis-tress syndrome (RDS)) and a possible rise in thenumber of instrumental deliver-ies.

Objective:
To determine the effectiveness and cost-effectiveness of induction oflabour after PPROM between 34 and 37 weeks gestation compared toexpectant monitoring.

Study Design:
Multicentre prospective randomised controlled trial.

Study Population:
Pregnant women with preterm premature rupture of the membranes at a gestational age from 34 + 0/7 weeks until 37 weeks.

Interventions:
We will compare induction of labour with expectant monitoring.

Outcome measures:
Primary outcome is neonatal infection. Secondary outcome measures arematernal morbidity (chorioamnionitis, puerperal sepsis) and neonataldisease, instrumental delivery rate, quality of life and costs.

Power/Data Analyses:
We anticipate that a reduction of neonatal infection from 7.5% to 2.5%will outweigh the differences of an increase in RDS and additionalcosts due to admission of the child due to prematurity. Under theseassumptions, we will randomise 520 women (two groups of 260).

Economic Evaluation:
As we expect a reduction of infection in the intervention group, theeco-nomic analysis will be a cost-effectiveness analysis. Long termoutcomes will be evaluated using modelling.

Time Schedule:
Total study time 36months.

Projectleaders:
Dr. C. Willekes, azM, Maastricht
Dr. B.W. Mol, MMC, Veldhoven

Projectmembers:
Drs. D.P. van der Ham, VieCuri, Venlo
Drs. D. Bijlenga, AMC, Amsterdam
Drs. S.M.C. Vijgen, AMC, Amsterdam

ICT-support:
Mr. R. Scholte, AMC, Amsterdam

Subsidy:
ZonMw - www.zonmw.nl