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Effect of Dexamethasone on Labour Induction in Term Pregnancies

NCT07109258 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

  • Labor Induction

Interventions

DRUG

Dexamethasone (Decadron) 8mg IM injection

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

DRUG

Misoprostol 25 mcg

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

DRUG

Both 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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-09-01
Completion
2025-09-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07109258 on ClinicalTrials.gov