NCT02673359

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Mohamed Sayed Abdelhafez · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Labour

Interventions

Type	Name	Description
DRUG	Progesterone	Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
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)

Timeline

• Start date: 2016-02-01
• Primary completion: 2023-12-01
• Completion: 2024-01-01
• First posted: 2016-02-03
• Last updated: 2023-04-10

Locations

3 sites across 1 country: Egypt