Prediction and Prevention of Twin Premature Birth 2021

Preterm Birth Clinical Trial

Official title:

Study on the Prediction and Prevention of Twin Premature Birth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061641
• Other study ID #: TPB 2021
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

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