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Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Primary Purpose

Premature Labour

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Sponsored by
Mohamed Sayed Abdelhafez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Labour focused on measuring Twins, Preterm labor, Progesterone, Short cervix

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women pregnant in dichorionic twins.
  • Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
  • No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria:

  • Age < 20 years or > 35 years.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
  • Monochorionic twins.
  • Known major fetal structural or chromosomal abnormality.
  • Intrauterine death of one fetus or death of both fetuses.
  • Fetal reduction in current pregnancy.
  • Cervical cerclage in current pregnancy.
  • Medical conditions that may lead to preterm delivery.
  • Rupture of membranes.
  • Vaginal bleeding.

Sites / Locations

  • Obstetrics and Gynecology Department in Mansoura University Hospital
  • Private practice settings

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Progesterone group

No treatment group

Arm Description

Women received vaginal progesterone suppositories

Women received no treatment

Outcomes

Primary Outcome Measures

Preterm labor before 34 weeks

Secondary Outcome Measures

Neonatal respiratory distress syndrome (RDS)
Early neonatal death (END).

Full Information

First Posted
December 24, 2014
Last Updated
January 13, 2015
Sponsor
Mohamed Sayed Abdelhafez
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1. Study Identification

Unique Protocol Identification Number
NCT02338830
Brief Title
Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Official Title
Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Sayed Abdelhafez

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix
Detailed Description
Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Labour
Keywords
Twins, Preterm labor, Progesterone, Short cervix

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progesterone group
Arm Type
Active Comparator
Arm Description
Women received vaginal progesterone suppositories
Arm Title
No treatment group
Arm Type
No Intervention
Arm Description
Women received no treatment
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Cyclogest
Intervention Description
Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
Primary Outcome Measure Information:
Title
Preterm labor before 34 weeks
Time Frame
Up to 34 weeks gestational age
Secondary Outcome Measure Information:
Title
Neonatal respiratory distress syndrome (RDS)
Time Frame
At birth
Title
Early neonatal death (END).
Time Frame
One month after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women pregnant in dichorionic twins. Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age. No symptoms, signs or other risk factors for preterm labor. Exclusion Criteria: Age < 20 years or > 35 years. Known allergy or contraindication (relative or absolute) to progesterone therapy. Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI). Monochorionic twins. Known major fetal structural or chromosomal abnormality. Intrauterine death of one fetus or death of both fetuses. Fetal reduction in current pregnancy. Cervical cerclage in current pregnancy. Medical conditions that may lead to preterm delivery. Rupture of membranes. Vaginal bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ahmed M Badawy, Prof
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Private practice settings
City
Mansoura
State/Province
Dakahlia
Country
Egypt

12. IPD Sharing Statement

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Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

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