UnknownNot Applicable

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

Egypt200 participantsStarted 2019-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women pregnant in dichorionic twins. * Transvaginal sonographic cervical length is \<25 mm at 18-22 weeks gestational age. * No symptoms, signs or other risk factors for preterm labor. Exclusion Criteria: * Known allergy or contraindication (relative or absolute) to progesterone therapy. * Monochorionic twins. * Known major fetal structural or chromosomal abnormality. * Intrauterine death of one fetus or death of both fetuses. * Fetal reduction in the current pregnancy. * Cervical cerclage in the current pregnancy. * Medical conditions that may lead to preterm delivery. * Rupture of membranes. * Vaginal bleeding.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preterm labor before 34 weeks gestations

Timeframe: Up to 34 weeks gestational age

Trial details

NCT IDNCT03781674

SponsorAswan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

hany f sallam, md

01022336052 hany.farouk@aswu.edu.eg

View on ClinicalTrials.gov More Twin; Pregnancy, Affecting Fetus or Newborn trials