ClinicalTrials.Veeva

Menu

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

C

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)

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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems