Clinical trial NCT02484820: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor
Official title: PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor: a Prospective, Randomized Monocentric Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Preterm Birth
pessary
threatened preterm labor
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of spontaneous delivery
timeFrame: 37 weeks of gestation
Secondary outcomes:
measure: Number of spontaneous delivery
timeFrame: 34 weeks of gestation
measure: Number of spontaneous delivery
timeFrame: 28 weeks of gestation
measure: Number of admission for preterm labor
timeFrame: from date of randomization until the date of the delivery
measure: Number of fetal-neonatal death
timeFrame: at delivery
measure: Number of birth death
timeFrame: From date of delivery until 6 weeks after the date of term
measure: Number of patients with neonatal morbidity
timeFrame: From date of delivery until 6 weeks after the date of term
measure: Number of patients with increase of vaginal discharge
timeFrame: from date of randomization until the date of the delivery
measure: Number of patients with spontaneous pessary ejection
timeFrame: from date of randomization until the date of the delivery
measure: Number of patients with discomfort
timeFrame: from date of randomization until the date of the delivery
measure: number of day between resolutive threatened preterm labor and delivery
timeFrame: At delivery
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Céline CHAULEUR, PhD
role: PRINCIPAL_INVESTIGATOR
References: