Prediction and Prevention of Twin Premature Birth 2021

Caixia Liu

Status and phase: Unknown; Phase 4

Conditions: Preterm Birth

Treatments: Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT05061641

TPB 2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

progesterone 200mg

Active Comparator group

Description:

Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg

Treatment:

Drug: Progesterone

progesterone 400mg

Experimental group

Description:

Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg

Treatment:

Drug: Progesterone

progesterone 600mg

Experimental group

Description:

Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg

Treatment:

Drug: Progesterone