CompletedNot Applicable

Intramuscular vs Rectal Progesterone in Preventing Preterm Labour After Cervical Cerclage

Pakistan820 participantsStarted 2021-10-26

Plain-language summary

Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.

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: Pregnant women aged 18-45 years Singleton pregnancy Gestational age between 16 and 24 weeks at enrollment Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage Willing to receive progesterone therapy and provide written informed consent Exclusion Criteria: Multiple pregnancy Known fetal anomalies Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease) History of allergy or hypersensitivity to progesterone or related compounds Contraindications to progesterone use Women who declined to participate or were non-compliant with follow-upInclusion Criteria: \- Exclusion Criteria: \-

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

Frequency of Preterm Birth (<37 Weeks)

Timeframe: 16-36 weeks until delivery

Trial details

NCT IDNCT07307092

SponsorHina Mukhtar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-25

View on ClinicalTrials.gov More Preterm Labour trials