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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05061641
Other study ID # TPB 2021
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2021
Est. completion date June 1, 2022

Study information

Verified date September 2021
Source Shengjing Hospital
Contact Liu caixia, Dr
Phone 18940251716
Email liucx1716@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
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.

Locations

Country Name City State
China caixia Liu Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Caixia Liu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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