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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00672-47 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pessary | Experimental | 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) |
|
| Control | No Intervention | Standard care only, No silicone pessary will be placed in the vagina. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone pessary | Device | Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Céline CHAULEUR, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | 42055 | France |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 |
| D000091642 | Urogenital Diseases |