Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor.

Preterm labor is still the major contributor of perinatal morbidity and mortality.
Threatened preterm labor affects 9% of all pregnancies. Cervical length measurement and fibronectin or ACTIM-partus test can detect women who are unlikely to deliver. Of the other group a small percentage will delivery during the first admission for threatened preterm labor. For the women who remained undelivered, the risk of preterm birth is increased up to 50%. No treatment is currently available. By supporting the cervix, a pessary could prevent preterm birth or reduce the severity of prematurity and thereby the associated neonatal outcome.

6 september 2016: Study halted on the advice of the DSMC based on the results of the interim analysis.

Women who remained undelivered after an episode of threatened preterm are at increased risk for preterm labor, half of these women will eventually deliver prematurely. No treatment is currently available for these women. This study will investigate if a cervical pessary is a solution for these high risk women, by supporting the cervix and to prolong pregnancy.

Duration of the study will be 33 months:
1. We will need a run-in period of three months for the study set up;

2. Twenty-four months for inclusion of the required number of cases;

3. 6 months for follow-up data collection and report of results.

Eligible women will be randomly allocated to receive either a cervical pessary or no intervention.
The cervical pessary will be placed in situ when undelivered, 48 hours after an episode of threatened preterm labor and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.