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Prediction and Prevention of Twin Premature Birth 2021

Study on the Prediction and Prevention of Twin Premature Birth

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05061641
Enrollment
300
Registered
2021-09-29
Start date
2021-05-01
Completion date
2022-06-01
Last updated
2021-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief 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.

Detailed 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

Interventions

DRUGProgesterone

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.

Sponsors

Caixia Liu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

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

Intervention model description

Prospective cohort study

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neonatal prognosisone weekPreterm 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.

Secondary

MeasureTime frameDescription
Gestational age and prolongation of gestational age at deliveryone yearGestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment

Countries

China

Contacts

Primary ContactLiu caixia, Dr
liucx1716@163.com18940251716

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026