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

Last updated: April 6, 2023
Sponsor: Mohamed Sayed Abdelhafez
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02673359
WR2
  • Ages 20-35
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofgestation.

Exclusion

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 Design

Total Participants: 220
Study Start date:
February 01, 2016
Estimated Completion Date:
January 31, 2024

Study 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.

Connect with a study center

  • Private practice settings

    Mansoura, Dakahlia
    Egypt

    Site Not Available

  • Obstetrics and Gynecology Department in Mansoura University Hospital

    Mansourah, Dakahlia 35111
    Egypt

    Active - Recruiting

  • Private practice settings

    Mansourah, Dakahlia
    Egypt

    Active - Recruiting

  • Obstetrics and Gynecology Department in Port Said University

    Port Said,
    Egypt

    Active - Recruiting

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