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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Preterm Birth

Treatments: Device: Silicone pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02484820

2015-A00672-47 (Other Identifier)

1508059

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimal age of 18 years
• Informed consent
• Confirmation of dating of pregnancy by first trimester echography.
• Episode of threatened preterm labour
• Singleton between 24 and 34 weeks of gestation
• Cervical length ≤20mm in cervimetry
• Pulmonary maturation completed
• ≤6 contractions by hour after 24 hours of tocolysis.

Exclusion criteria

• Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
• Spontaneous rupture of membranes at the time of randomization
• Cervical cerclage in situ
• Uterus malformations
• Antecedent of conisation
• Active vaginal bleeding, placenta previa
• Intra-amniotic infection
• Hydramnios
• Maternal chronic pathology (hypertension, diabetes)
• Anomaly of breathing foetal rate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Pessary

Experimental group

Description:

Silicone pessary is associated with standard care Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)

Treatment:

Device: Silicone pessary

Control

No Intervention group

Description:

Standard care only, No silicone pessary will be placed in the vagina.