UnknownPhase 4

Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM

Egypt220 participantsStarted 2016-02

Plain-language summary

The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

Who can participate

Age range

20 Years – 35 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 with singleton pregnancy. * History of preterm labor and/or midtrimester miscarriage in a previous pregnancy. * Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation. Exclusion Criteria: * Age \< 20 or \> 35 years. * Congenital uterine malformation. * Multifetal pregnancy. * Known major fetal structural or chromosomal abnormality. * Known allergy or contraindication (relative or absolute) to progesterone therapy. * Presence of contraindication to cervical cerclage. * Medical conditions complicating pregnancy. * 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 35 weeks

Timeframe: Up to 35 weeks gestational age

Trial details

NCT IDNCT02673359

SponsorMohamed Sayed Abdelhafez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Waleed El-refaie, Dr

wrefaie@yahoo.com

View on ClinicalTrials.gov More Premature Labour trials