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

April 6, 2023 updated by: Mohamed Sayed Abdelhafez

Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Port Said, Egypt
        • Recruiting
        • Obstetrics and Gynecology Department in Port Said University
    • Dakahlia
      • Mansourah, Dakahlia, Egypt, 35111
        • Recruiting
        • Obstetrics and Gynecology Department in Mansoura University Hospital
      • Mansourah, Dakahlia, Egypt
        • Recruiting
        • Private practice settings

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Progesterone group
Vaginal progesterone suppositories will be given
Drug: Progesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Other Names:
  • Prontogest
  • Cyclogest
Active Comparator: Cerclage group
Cervical cerclage will be performed.
Procedure: Cervical cerclage
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)
Other Names:
  • Cervical stitch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preterm labor before 35 weeks
Time Frame: Up to 35 weeks gestational age
Up to 35 weeks gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery before 37 weeks
Time Frame: Up to 37 weeks gestational age
Up to 37 weeks gestational age
Low birth weight (LBW)
Time Frame: At birth
Birth weight of a living neonate of < 2500 gm regardless of gestational age
At birth
Neonatal respiratory distress syndrome (RDS)
Time Frame: At birth
At birth
Early neonatal death (END)
Time Frame: One month after birth
One month after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Sayed Abdelhafez

Investigators

  • Principal Investigator: Waleed El-refaie, Dr, Port Said University
  • Study Chair: Ahmed M Badawy, Prof, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WR2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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