Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Overview
- Phase
- Phase 4
- Intervention
- Progesterone
- Conditions
- Premature Labour
- Sponsor
- Mohamed Sayed Abdelhafez
- Enrollment
- 182
- Locations
- 2
- Primary Endpoint
- Preterm labor before 34 weeks
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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)
Investigators
Mohamed Sayed Abdelhafez
Dr
Mansoura University
Eligibility Criteria
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.
Arms & Interventions
Progesterone group
Women received vaginal progesterone suppositories
Intervention: Progesterone
Outcomes
Primary Outcomes
Preterm labor before 34 weeks
Time Frame: Up to 34 weeks gestational age
Secondary Outcomes
- Neonatal respiratory distress syndrome (RDS)(At birth)
- Early neonatal death (END).(One month after birth)