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

Phase 4

Recruiting

• Conditions: Premature Labour
• Interventions: Procedure: Cervical cerclage; Drug: Progesterone

• Registration Number: NCT02673359
• Lead Sponsor: Mohamed Sayed Abdelhafez

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerclage group	Cervical cerclage	Cervical cerclage will be performed.
Progesterone group	Progesterone	Vaginal progesterone suppositories will be given

Primary Outcome Measures

Name	Time	Method
Preterm labor before 35 weeks	Up to 35 weeks gestational age

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Obstetrics and Gynecology Department in Mansoura University Hospital; 🇪🇬 Mansourah, Dakahlia, Egypt

Private practice settings; 🇪🇬 Mansourah, Dakahlia, Egypt

Obstetrics and Gynecology Department in Port Said University; 🇪🇬 Port Said, Egypt