NCT07109258 Effect of Dexamethasone on Labour Induction in Term Pregnancies
| NCT ID | NCT07109258 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cairo University |
| Condition | Labor Induction |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 150 participants in total. It began in 2025-05-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07109258 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Labor Induction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07109258 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07109258 currently recruiting?
Yes, NCT07109258 is actively recruiting participants. Contact the research team at a.f.dessouki@gmail.com for enrollment information.
Where is the NCT07109258 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07109258 clinical trial?
NCT07109258 is sponsored by Cairo University. The trial plans to enroll 150 participants.