Effect of Dexamethasone on Labour Induction in Term Pregnancies (NCT07109258) | Clinical Trial Compass
RecruitingEarly Phase 1
Effect of Dexamethasone on Labour Induction in Term Pregnancies
Egypt150 participantsStarted 2025-05-01
Plain-language summary
The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies.
Primary outcome:
The interval between initiation of induction and beginning of the active phase of labour.
Secondary outcomes:
* Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
* Duration of second stage of labour
* Mode of delivery.
* Fetal outcome.
Group A:
Will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
Group B:
Will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Group C:
Will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Who can participate
Age range
18 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:
* Age \> 18 years.
* Nulliparous.
* Vertex presentation.
* Singleton pregnancy.
* Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation.
* No contraindication for vaginal delivery.
Exclusion Criteria:
* Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.
* Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
* Preterm labour and preterm rupture of membranes.
* Gestational age \<39 weeks of gestation.
* Fetal macrosomia \> 4kg (estimated by u/s).
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
1
The interval between initiation of induction and beginning of the active phase of labour.
Timeframe: The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.