Prediction and Prevention of Twin Premature Birth 2021

• Sponsor: Caixia Liu (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05061641
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 23.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Drug: Progesterone	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective cohort studyProspective cohort study
• Masking: Double (Participant, Care Provider)
• Masking Description: The participants and the treating physicians were not informed of the grouping
• Primary Purpose: Treatment
• Official Title: Study on the Prediction and Prevention of Twin Premature Birth
• Actual Study Start Date: May 1, 2021
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Neonatal prognosis [one week]

   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.

Secondary Outcome Measures

1. Gestational age and prolongation of gestational age at delivery [one year]

   Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	caixia Liu	Shenyang	Liaoning	China	110001

Sponsors and Collaborators

• Caixia Liu

Investigators

• Study Chair: Wei jun, Dr, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caixia Liu, Shengjing hospital, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT05061641
• Other Study ID Numbers: TPB 2021
• First Posted: Sep 29, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Premature Birth; Progesterone

Study Results

No Results Posted as of Sep 29, 2021