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

NCT ID: NCT02484820

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2023-01-31

Brief Summary

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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pessary

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)

Group Type: EXPERIMENTAL

Silicone pessary

Intervention Type: DEVICE

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Silicone pessary

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline CHAULEUR, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-A00672-47

Identifier Type: OTHER

Identifier Source: secondary_id

1508059

Identifier Type: -

Identifier Source: org_study_id