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

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Labour

Intervention: Progesterone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Mohamed Sayed Abdelhafez

Official(s) and/or principal investigator(s):
Waleed El-refaie, Dr, Principal Investigator, Affiliation: Mansoura University
Mohamed S Abdelhafez, Dr, Study Director, Affiliation: Mansoura University
Ahmed M Badawy, Prof, Study Chair, Affiliation: Mansoura University

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Preterm labor before 34 weeks

Secondary outcome:

Neonatal respiratory distress syndrome (RDS)

Early neonatal death (END).

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)

Eligibility

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

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.

- Vaginal bleeding.

Locations and Contacts

Obstetrics and Gynecology Department in Mansoura University Hospital, Mansoura, Dakahlia 35111, Egypt

Private practice settings, Mansoura, Dakahlia, Egypt

Additional Information

Starting date: June 2012
Last updated: January 13, 2015

Page last updated: August 23, 2015

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