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

Study Overview
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Brief Summary
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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.

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

Conditions
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Preterm Birth

Intervention / Treatment
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* Device: Silicone pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pessary<br>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<br>* Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)<br>|
| No Intervention: Control<br>Standard care only, No silicone pessary will be placed in the vagina. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm Birth, pessary, threatened preterm labor