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

Preterm Birth Clinical Trial

— PREMAPESSAIRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484820
• Other study ID #: 1508059
• Secondary ID: 2015-A00672-47
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 31, 2023
• Est. primary completion date: October 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth

Intervention

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)

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of fetal-neonatal death	Number of fetal-neonatal death at delivery	at delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	number of day between resolutive threatened preterm labor and delivery	Comparison of number of day between the two groups of the study	At delivery