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Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

Primary Purpose

Premature Labour

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Progesterone
Cervical cerclage
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 Preterm labor, Short cervix, Progesterone, Cervical cerclage

Eligibility Criteria

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

Inclusion Criteria:

  • Women with singleton pregnancy.
  • History of preterm labor and/or midtrimester miscarriage in a previous pregnancy.
  • Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.

Exclusion Criteria:

  • Age < 20 or > 35 years.
  • Congenital uterine malformation.
  • Multifetal pregnancy.
  • Known major fetal structural or chromosomal abnormality.
  • Known allergy or contraindication (relative or absolute) to progesterone therapy.
  • Presence of contraindication to cervical cerclage.
  • Medical conditions complicating pregnancy.
  • Vaginal bleeding.

Sites / Locations

  • Obstetrics and Gynecology Department in Mansoura University HospitalRecruiting
  • Private practice settingsRecruiting
  • Obstetrics and Gynecology Department in Port Said UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Progesterone group

Cerclage group

Arm Description

Vaginal progesterone suppositories will be given

Cervical cerclage will be performed.

Outcomes

Primary Outcome Measures

Preterm labor before 35 weeks

Secondary Outcome Measures

Delivery before 37 weeks
Low birth weight (LBW)
Birth weight of a living neonate of < 2500 gm regardless of gestational age
Neonatal respiratory distress syndrome (RDS)
Early neonatal death (END)

Full Information

First Posted
February 1, 2016
Last Updated
April 6, 2023
Sponsor
Mohamed Sayed Abdelhafez
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1. Study Identification

Unique Protocol Identification Number
NCT02673359
Brief Title
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM
Official Title
Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

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
The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.
Detailed Description
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progesterone group
Arm Type
Active Comparator
Arm Description
Vaginal progesterone suppositories will be given
Arm Title
Cerclage group
Arm Type
Active Comparator
Arm Description
Cervical cerclage will be performed.
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Cyclogest, Prontogest
Intervention Description
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Intervention Type
Procedure
Intervention Name(s)
Cervical cerclage
Other Intervention Name(s)
Cervical stitch
Intervention Description
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
Primary Outcome Measure Information:
Title
Preterm labor before 35 weeks
Time Frame
Up to 35 weeks gestational age
Secondary Outcome Measure Information:
Title
Delivery before 37 weeks
Time Frame
Up to 37 weeks gestational age
Title
Low birth weight (LBW)
Description
Birth weight of a living neonate of < 2500 gm regardless of gestational age
Time Frame
At birth
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 with singleton pregnancy. History of preterm labor and/or midtrimester miscarriage in a previous pregnancy. Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation. Exclusion Criteria: Age < 20 or > 35 years. Congenital uterine malformation. Multifetal pregnancy. Known major fetal structural or chromosomal abnormality. Known allergy or contraindication (relative or absolute) to progesterone therapy. Presence of contraindication to cervical cerclage. Medical conditions complicating pregnancy. Vaginal bleeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed El-refaie, Dr
Email
wrefaie@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Port Said 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
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Name
Private practice settings
City
Mansourah
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Name
Obstetrics and Gynecology Department in Port Said University
City
Port Said
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

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