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

NCT02484820 | Completed

• 2 other identifiers: 15080592015-A00672-47
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Keywords

Preterm Birth; pessary; threatened preterm labor

Outcome Measures

Primary Outcomes (1)

• Number of spontaneous delivery

  Comparison of the number of spontaneous delivery before 37 completed weeks of gestation for pregnant women after resolutive threatened preterm labour between 20 and 34 weeks of gestation between the 2 groups of the study.

  37 weeks of gestation

Secondary Outcomes (10)

• Number of spontaneous delivery

  34 weeks of gestation

• Number of spontaneous delivery

  28 weeks of gestation

• Number of admission for preterm labor

  from date of randomization until the date of the delivery

• Number of fetal-neonatal death

  at delivery

• Number of birth death

  From date of delivery until 6 weeks after the date of term

Study Arms (2)

Pessary

EXPERIMENTAL

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)

Device: Silicone pessary

Control

NO INTERVENTION

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

Interventions

Silicone pessary DEVICE

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

Pessary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Céline CHAULEUR, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 30, 2015
• Study Start: December 1, 2015
• Primary Completion: October 8, 2022
• Study Completion: January 31, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)