Prediction and Prevention of Twin Premature Birth 2021

Study on the Prediction and Prevention of Twin Premature Birth

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: Progesterone

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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liu caixia, Dr; Phone Number: 18940251716; Email: liucx1716@163.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • Caixia Liu
      • Contact: Liu caixia, professor; Phone Number: 10027 86-024-96615; Email: 18940252882@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: progesterone 200mg; Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg	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.; Other Names: surgical treatment
Experimental: progesterone 400mg; Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg	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.; Other Names: surgical treatment
Experimental: progesterone 600mg; Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg	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.; Other Names: surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Caixia Liu
• Investigators: Study Chair: Wei jun, Dr, 1050880483@qq.com

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 26, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: TPB 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No