Prediction and Prevention of Twin Premature Birth 2021
- Registration Number
- NCT05061641
- Lead Sponsor
- Caixia Liu
- Brief Summary
Research Objectives:
1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks.
- Detailed Description
Research Objectives:
1. Establish a prediction and scoring system for twin premature birth.
2. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. The optimal dose of atosiban for the treatment of twin premature birth.
5. The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 300
twins with cervical length ≤ 25 mm by vaginal ultrasound at 14-32 weeks no contractions, abdominal pain and vaginal bleeding No complicated twin complications occurred during pregnancy
Patients undergoing selective cervical ligation before 14 weeks of gestation history of liver problems or cholestasis during pregnancy Abnormal liver enzymes Abnormal renal function Local allergy to trace natural progesterone Recurrent vaginal bleeding Recurrent vaginal infection Ultrasound diagnosis of fetal abnormality Intrauterine treatment for fetal abnormalities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description progesterone 200mg Progesterone Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg progesterone 400mg Progesterone Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg progesterone 600mg Progesterone Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg
- Primary Outcome Measures
Name Time Method Neonatal prognosis one week Preterm birth rate (\<37 weeks of gestation), early preterm birth rate (\<32 weeks of gestation), need to receive anti-tocolytic treatment; Rates of premature rupture of membranes (\<37 weeks), neonatal perinatal mortality and morbidity.
- Secondary Outcome Measures
Name Time Method Gestational age and prolongation of gestational age at delivery one year Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
Trial Locations
- Locations (1)
caixia Liu
🇨🇳Shenyang, Liaoning, China