Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix

Phase 4

Completed

• Conditions: Premature Labour
• Interventions: Drug: Progesterone

• Registration Number: NCT02338830
• Lead Sponsor: Mohamed Sayed Abdelhafez

Brief Summary

To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic twin pregnancies who have sonographic short cervix

Detailed Description

Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24 weeks gestational age without symptoms, signs or other risk factors of preterm labor will be included in the study. All women will be randomly divided into two groups; one group (study group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 20-24 weeks gestational age (study group) and the other group received no treatment (control group)

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Study First Submitted: 2014-12-24
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-11
• Last Update Submitted: 2015-01-13
• Study First Posted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

Inclusion Criteria

• Women pregnant in dichorionic twins.
• Transvaginal sonographic cervical length is 20-25 mm at 20-24 weeks gestational age.
• No symptoms, signs or other risk factors for preterm labor.

Exclusion Criteria

• Age < 20 years or > 35 years.
• Known allergy or contraindication (relative or absolute) to progesterone therapy.
• Pregnancy by in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI).
• Monochorionic twins.
• Known major fetal structural or chromosomal abnormality.
• Intrauterine death of one fetus or death of both fetuses.
• Fetal reduction in current pregnancy.
• Cervical cerclage in current pregnancy.
• Medical conditions that may lead to preterm delivery.
• Rupture of membranes.
• Vaginal bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone group	Progesterone	Women received vaginal progesterone suppositories

Primary Outcome Measures

Name	Time	Method
Preterm labor before 34 weeks	Up to 34 weeks gestational age

Secondary Outcome Measures

Name	Time	Method
Early neonatal death (END).	One month after birth
Neonatal respiratory distress syndrome (RDS)	At birth

Trial Locations

Locations (2)

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

Private practice settings; 🇪🇬 Mansoura, Dakahlia, Egypt