Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Sonographic Short Cervix and History of Preterm Labor and/or Midtrimester Miscarriage
Overview
- Phase
- Phase 4
- Intervention
- Progesterone
- Conditions
- Premature Labour
- Sponsor
- Mohamed Sayed Abdelhafez
- Enrollment
- 220
- Locations
- 3
- Primary Endpoint
- Preterm labor before 35 weeks
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Mohamed Sayed Abdelhafez
Dr
Mansoura University
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.
Arms & Interventions
Progesterone group
Vaginal progesterone suppositories will be given
Intervention: Progesterone
Cerclage group
Cervical cerclage will be performed.
Intervention: Cervical cerclage
Outcomes
Primary Outcomes
Preterm labor before 35 weeks
Time Frame: Up to 35 weeks gestational age
Secondary Outcomes
- Delivery before 37 weeks(Up to 37 weeks gestational age)
- Early neonatal death (END)(One month after birth)
- Low birth weight (LBW)(At birth)
- Neonatal respiratory distress syndrome (RDS)(At birth)