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Role of 200 mg Versus 400mg Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation

NCT03781674 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-02-15

No results posted yet for this study

Summary

The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

Conditions

  • Twin; Pregnancy, Affecting Fetus or Newborn

Interventions

DRUG

progesterone 400mg

Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age

DRUG

progesterone 200mg

Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age

DRUG

placebo to progesterone 200mg

Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age

DRUG

placebo to progesterone 400mg

Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age

Sponsors & Collaborators

  • Aswan University Hospital

    lead OTHER

Principal Investigators

  • hany f sallam, md · Aswan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-31
Completion
2022-03-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781674 on ClinicalTrials.gov