Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour: Nifedipine versus placebo in the treatment of preterm premature rupture of membranes.

Rationale:

At present, women with premature preterm rupture of membranes (PPROM) are in some cases treated with tocolytics and in other cases not. It is unclear whether treatment with tocolytics should take place in order to delay labor.



Objective:

To assess whether in women with early PPROM tocolytics improve perinatal outcome.



Study design:

Randomized placebo controlled trial.



Study population:

Women with PPROM between 24+0/7 and 33+6/7 weeks gestational age.



Intervention:

Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes).



Main study parameters/endpoints:

Primary outcome is composite neonatal morbidity status, i.e. severe morbidity and death at 6 months. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days in hospital.

The aim of the study is to assess whether in women with early PPROM tocolytics improve perinatal outcome.

In view of the relatively small sample size, the fact that both treatments are already applied and are both mentioned in the Dutch guidelines, an interim analysis is not planned.

Random allocation to nifedipine (intervention) or placebo (control) during the period until the start of signs of active labour (≥ 3 contractions per 10 minutes).