Prediction and Prevention of Twin Premature Birth 2021

Study Overview
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Brief Summary
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Research Objectives: Establish a prediction and scoring system for twin premature birth. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. To investigate the effect of stress cervical ligation in preventing premature delivery of twins. The optimal dose of atosiban for the treatment of twin premature birth. The influence of delivery mode on twin premature infants under 32 weeks.

Detailed Description
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Research Objectives: Establish a prediction and scoring system for twin premature birth. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. To investigate the effect of stress cervical ligation in preventing premature delivery of twins. The optimal dose of atosiban for the treatment of twin premature birth. The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection

Official Title
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Study on the Prediction and Prevention of Twin Premature Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Prospective cohort study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone 200mg<br>Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg | Drug: Progesterone<br>* The delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.<br>* Other names: surgical treatment;|
| Experimental: progesterone 400mg<br>Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg | Drug: Progesterone<br>* The delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.<br>* Other names: surgical treatment;|
| Experimental: progesterone 600mg<br>Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg | Drug: Progesterone<br>* The delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.<br>* Other names: surgical treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal prognosis | 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. | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age and prolongation of gestational age at delivery | Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment | one year |