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

Premature Labour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338830
• Other study ID #: WR1
• Status: Completed
• Phase: Phase 4
• First received: December 24, 2014
• Last updated: January 13, 2015
• Start date: June 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Labour

Intervention

Drug:
• Progesterone
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

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansoura	Dakahlia
Egypt	Private practice settings	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm labor before 34 weeks		Up to 34 weeks gestational age	No
Secondary	Neonatal respiratory distress syndrome (RDS)		At birth	No
Secondary	Early neonatal death (END).		One month after birth	No