PREMAPESSAIRE: Prevention of Preterm Birth in Singletons Using Pessary After Resolutive Threatened Preterm Labor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Number of spontaneous delivery [37 weeks of gestation]
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.
Secondary Outcome Measures
- Number of spontaneous delivery [34 weeks of gestation]
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.
- Number of spontaneous delivery [28 weeks of gestation]
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.
- Number of admission for preterm labor [from date of randomization until the date of the delivery]
Comparison of the number of admission for preterm labor from date of randomization until the date of the delivery between the 2 groups.
- Number of fetal-neonatal death [at delivery]
Number of fetal-neonatal death at delivery
- Number of birth death [From date of delivery until 6 weeks after the date of term]
Number of birth death at delivery until 6 weeks after the date of term
- Number of patients with neonatal morbidity [From date of delivery until 6 weeks after the date of term]
Number of patient with neonatal morbidity at delivery until 6 weeks after the date of term
- Number of patients with increase of vaginal discharge [from date of randomization until the date of the delivery]
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.
- Number of patients with spontaneous pessary ejection [from date of randomization until the date of the delivery]
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.
- Number of patients with discomfort [from date of randomization until the date of the delivery]
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.
- number of day between resolutive threatened preterm labor and delivery [At delivery]
Comparison of number of day between the two groups of the study
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Saint-Etienne | Saint-Etienne | France | 42055 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Saint Etienne
Investigators
- Principal Investigator: Céline CHAULEUR, PhD, CHU SAINT-ETIENNE
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1508059
- 2015-A00672-47