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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)
Chu Saint-Etienne
Saint-Etienne, France
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.
Time frame: 37 weeks of gestation
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.
Time frame: 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.
Time frame: 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.
Time frame: from date of randomization until the date of the delivery
Number of fetal-neonatal death
Number of fetal-neonatal death at delivery
Time frame: at delivery
Number of birth death
Number of birth death at delivery until 6 weeks after the date of term
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At delivery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.