Prediction and Prevention of Twin Premature Birth 2021

NCT ID: NCT05061641

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective cohort study
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
The participants and the treating physicians were not informed of the grouping

Study Groups

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progesterone 200mg

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

Group Type ACTIVE_COMPARATOR

Progesterone

Intervention Type DRUG

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.

progesterone 400mg

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

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

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.

progesterone 600mg

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

Group Type EXPERIMENTAL

Progesterone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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surgical treatment

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Caixia Liu

OTHER

Sponsor Role lead

Responsible Party

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Caixia Liu

Shengjing hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei jun, Dr

Role: STUDY_CHAIR

[email protected]

Locations

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caixia Liu

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu caixia, Dr

Role: CONTACT

18940251716

Facility Contacts

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Liu caixia, professor

Role: primary

86-024-96615 ext. 10027

Other Identifiers

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TPB 2021

Identifier Type: -

Identifier Source: org_study_id

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