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

NCT02338830 | Completed Phase 4

• 1 other identifier: WR1
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Premature Labour

Keywords

Twins; Preterm labor; Progesterone; Short cervix

Outcome Measures

Primary Outcomes (1)

• Preterm labor before 34 weeks

  Up to 34 weeks gestational age

Secondary Outcomes (2)

• Neonatal respiratory distress syndrome (RDS)

  At birth

• Early neonatal death (END).

  One month after birth

Study Arms (2)

Progesterone group

ACTIVE COMPARATOR

Women received vaginal progesterone suppositories

Drug: Progesterone

No treatment group

NO INTERVENTION

Women received no treatment

Interventions

Progesterone DRUG

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

Also known as: Cyclogest

Progesterone group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Sayed Abdelhafez: lead

Study Sites (2)

Obstetrics and Gynecology Department in Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

Location

Private practice settings

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Waleed El-refaie, Dr

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, Dr

  Mansoura University

  STUDY DIRECTOR

• Ahmed M Badawy, Prof

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: January 14, 2015
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

EG (2)