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Prediction and Prevention of Twin Premature Birth 2021

Primary Purpose

Preterm Birth

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Progesterone
Sponsored by
Caixia Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Birth

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • caixia LiuRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

progesterone 200mg

progesterone 400mg

progesterone 600mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 26, 2021
Last Updated
September 21, 2021
Sponsor
Caixia Liu
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1. Study Identification

Unique Protocol Identification Number
NCT05061641
Brief Title
Prediction and Prevention of Twin Premature Birth 2021
Official Title
Study on the Prediction and Prevention of Twin Premature Birth
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Caixia Liu

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Research Objectives: Establish a prediction and scoring system for twin premature birth. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. To investigate the effect of stress cervical ligation in preventing premature delivery of twins. The optimal dose of atosiban for the treatment of twin premature birth. The influence of delivery mode on twin premature infants under 32 weeks.
Detailed Description
Research Objectives: Establish a prediction and scoring system for twin premature birth. To investigate the curative effect of 200mg,400mg and 600mg of vaginal progesterone in the prevention of twin premature birth. To investigate the effect of stress cervical ligation in preventing premature delivery of twins. The optimal dose of atosiban for the treatment of twin premature birth. The influence of delivery mode on twin premature infants under 32 weeks. It has now entered the second phase: clinical data collection

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Prospective cohort study
Masking
ParticipantCare Provider
Masking Description
The participants and the treating physicians were not informed of the grouping
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
progesterone 200mg
Arm Type
Active Comparator
Arm Description
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 200mg
Arm Title
progesterone 400mg
Arm Type
Experimental
Arm Description
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 400mg
Arm Title
progesterone 600mg
Arm Type
Experimental
Arm Description
Each group was given prophylactic vaginal progesterone up to 34 weeks of gestation，Vaginal progesterone 600mg
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
surgical treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neonatal prognosis
Description
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.
Time Frame
one week
Secondary Outcome Measure Information:
Title
Gestational age and prolongation of gestational age at delivery
Description
Gestational age at which symptoms of preterm birth occur and gestational age at delivery after treatment
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu caixia, Dr
Phone
18940251716
Email
liucx1716@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei jun, Dr
Organizational Affiliation
1050880483@qq.com
Official's Role
Study Chair
Facility Information:
Facility Name
caixia Liu
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu caixia, professor
Phone
86-024-96615
Ext
10027
Email
18940252882@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Prediction and Prevention of Twin Premature Birth 2021

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