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

PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Device: Silicone pessary

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Chu Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Device: 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)
No Intervention: Control; Standard care only, No silicone pessary will be placed in the vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of spontaneous delivery	Comparison of the number of spontaneous delivery before 34 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.	34 weeks of gestation
Number of spontaneous delivery	Comparison of the number of spontaneous delivery before 28 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.	28 weeks of gestation
Number of admission for preterm labor	Comparison of the number of admission for preterm labor from date of randomization until the date of the delivery between the 2 groups.	from date of randomization until the date of the delivery
Number of fetal-neonatal death	Number of fetal-neonatal death at delivery	at delivery
Number of birth death	Number of birth death at delivery until 6 weeks after the date of term	From date of delivery until 6 weeks after the date of term
Number of patients with neonatal morbidity	Number of patient with neonatal morbidity at delivery until 6 weeks after the date of term	From date of delivery until 6 weeks after the date of term
Number of patients with increase of vaginal discharge	Comparison of the number of patients with increase of vaginal discharge from date of randomization until the date of the delivery between the 2 groups of the study.	from date of randomization until the date of the delivery
Number of patients with spontaneous pessary ejection	Comparison of the number of patients with pessary ejection from date of randomization until the date of the delivery between the 2 groups of the study.	from date of randomization until the date of the delivery
Number of patients with discomfort	Comparison of the number of patients with discomfort from date of randomization until the date of the delivery between the 2 groups of the study. The discomfort is measure by a standardized questionnaire.	from date of randomization until the date of the delivery
number of day between resolutive threatened preterm labor and delivery	Comparison of number of day between the two groups of the study	At delivery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Céline CHAULEUR, PhD, Chu Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 8, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Preterm Birth; pessary; threatened preterm labor
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: 1508059; 2015-A00672-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No