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CompletedNCT02338830Updated Jan 15, 2015

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

A Phase 4 interventional study of Progesterone in Premature Labour, sponsored by Mohamed Sayed Abdelhafez. Completed at 2 sites in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2015-01-15.

Sponsored by Mohamed Sayed Abdelhafez · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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)

02

Conditions studied

  • Premature Labour

Keywords

  • Twins
  • Preterm labor
  • Progesterone
  • Short cervix
03

In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's enrollment of 182 is above the median of 110 across 155 interventional studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Mohamed Sayed Abdelhafez is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
182 participants (actual)

Study arms

  • Active comparator
    Progesterone group

    Women received vaginal progesterone suppositories

    Drug: Progesterone

  • No intervention
    No treatment group

    Women received no treatment

Interventions

  • DrugProgesterone

    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

06

What researchers measure

Primary outcomes

  1. Preterm labor before 34 weeks

    Time frame: Up to 34 weeks gestational age

Secondary outcomes

  1. Neonatal respiratory distress syndrome (RDS)

    Time frame: At birth

  2. Early neonatal death (END).

    Time frame: One month after birth

07

Study locations

2 sites
  • Obstetrics and Gynecology Department in Mansoura University Hospital
    Mansoura, Dakahlia 35111, Egypt
  • Private practice settings
    Mansoura, Dakahlia, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02338830
Lead sponsor
Mohamed Sayed Abdelhafez
Responsible party
Mohamed Sayed Abdelhafez (Dr, Mansoura University) — Sponsor-investigator
First posted
Jan 14, 2015
Start date
Jun 2012
Primary completion
Oct 2014
Completion
Nov 2014
Last update
Jan 15, 2015

Study contacts

Waleed El-refaie, Dr
principal investigator · Mansoura University
Mohamed S Abdelhafez, Dr
study director · Mansoura University
Ahmed M Badawy, Prof
study chair · Mansoura University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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