RecruitingEarly Phase 1NCT07109258

Effect of Dexamethasone on Labour Induction in Term Pregnancies


Sponsor

Cairo University

Enrollment

150 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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).

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Interventions

DRUGDexamethasone (Decadron) 8mg IM injection

one dose of IM dexamethasone sodium phosphate 8 mg (2 mL) given at the start of labour induction

DRUGMisoprostol 25 mcg

vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.

DRUGBoth Misoprostol 25 mcg & Dexamethasone 8mg IM injection

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.


Locations(1)

Cairo University Hospital (Kasr Al Ainy)

Cairo, Manial, Egypt

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NCT07109258


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