Prediction and Prevention of Twin Premature Birth 2021

NCT05061641 | Unknown Phase 4 DMC

• 1 other identifier: TPB 2021
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Research Objectives:

1. 1.Establish a prediction and scoring system for twin premature birth.
2. 2.To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth.
3. 3.To investigate the effect of stress cervical ligation in preventing premature delivery of twins.
4. 4.The optimal dose of atosiban for the treatment of twin premature birth.
5. 5.The influence of delivery mode on twin premature infants under 32 weeks.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gestational age and prolongation of gestational age at delivery

  one year

Study Arms (3)

progesterone 200mg

ACTIVE COMPARATOR

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

Drug: Progesterone

progesterone 400mg

EXPERIMENTAL

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

Drug: Progesterone

progesterone 600mg

EXPERIMENTAL

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

Drug: Progesterone

Interventions

Progesterone 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.

Also known as: surgical treatment

progesterone 200mg; progesterone 400mg; progesterone 600mg

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Caixia Liu: lead

Study Sites (1)

caixia Liu

Shenyang, Liaoning, 110001, China

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Wei jun, Dr

  1050880483@qq.com

  STUDY CHAIR

Central Study Contacts

Liu caixia, Dr

CONTACT

18940251716; liucx1716@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants and the treating physicians were not informed of the grouping
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shengjing hospital

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: September 29, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)