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

Mohamed Sayed Abdelhafez182 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

182

Conditions

Premature Labour

Interventions

ProgesteroneDRUG

Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (2)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

Outcomes

Primary Outcomes

Preterm labor before 34 weeks

Time frame: Up to 34 weeks gestational age

Secondary Outcomes

Neonatal respiratory distress syndrome (RDS)

Time frame: At birth

Early neonatal death (END).

Time frame: One month after birth

Data from ClinicalTrials.gov

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