NCT02484820: PREMAPESSAIRE

Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor

Completed NA Last updated 24 May 2023

What this trial tests

NA trial testing Silicone pessary in Preterm Birth in 168 participants. Completed in 31 January 2023.

Timeline

1 December 2015

Primary endpoint
8 October 2022

31 January 2023

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Saint Etienne
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	168
Start date	1 December 2015
Primary completion	8 October 2022
Estimated completion	31 January 2023
Sites	1 location across France

Drugs / interventions tested

• Silicone pessary

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Who can join

18 and older, female only, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In France, threatened preterm labour concerns 6.5% of pregnancies and is associated with a premature birth in 25.4% of cases.

After 48 hours effective tocolysis, patients do not receive any further treatment while their risk of premature birth has risen from 6.5% to 25%.

A pessary is a silicone ring encircling the cervix. It was initially used as medical treatment of genital prolapse but studies were also conducted for pregnant women in 2 high-risk premature birth situations: cervical incompetence and twin pregnancies.

The multicenter PECEP trial conducted by Goya and al. in asymptomatic short cervix patients between 18 and 22 weeks of gestation showed a significant reduction of premature birth before 34 and 37 weeks of gestation. Thereby, the investigator assume that use of pessaries in patients presenting a resolutive threatened preterm labor will also be effective.

To evaluate this hypothesis, the investigator designed a randomized prospective single-center open clinical trial comparing pessary associated with standard care (1st group) versus standard care only (2nd group) in patients experiencing an episode of resolutive threatened preterm labor.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cervical pessary for preventing preterm birth in singleton pregnancies.
   Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. · · 2022 · cited 10× · PMID 36453699 · DOI 10.1002/14651858.cd014508