Effect of Dexamethasone on Labour Induction in Term Pregnancies

NCT07109258 | Recruiting Early Phase 1 DMC

• 1 other identifier: MS-552-2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Induction

Keywords

Labor Induction; Dexamethasone; Misoprostol; Term pregnancies

Outcome Measures

Primary Outcomes (1)

• The interval between initiation of induction and beginning of the active phase of labour.

  Assessed hourly

  The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.

Secondary Outcomes (5)

• Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).

  Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation), assessed hourly up to 24 hours.

• Duration of second stage of labour

  Recorded immediately with delivery of the baby

• Mode of delivery

  After induction attempt (24 hours)

• Fetal outcome

  At 1 and 5 minutes after delivery

• Fetal Outcome

  Recorded within 24 hours after delivery

Study Arms (3)

Group A

EXPERIMENTAL

They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).

Drug: Dexamethasone (Decadron) 8mg IM injection

Group B

ACTIVE COMPARATOR

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

Drug: Misoprostol 25 mcg

Group C

EXPERIMENTAL

They 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.

Drug: Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection

Interventions

Dexamethasone (Decadron) 8mg IM injection DRUG

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

Group A

Misoprostol 25 mcg DRUG

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

Group B

Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection DRUG

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.

Group C

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospital (Kasr Al Ainy)

Cairo, Manial, 11562, Egypt

RECRUITING

Related Publications (4)

• Vilas-Boas LS, Sanches MPR, Araujo Junior E, Peixoto AB, Mattar R, Santos LRRD, Pares DBDS, Sun SY. Evaluation of the efficacy of labor induction with vaginal misoprostol in a low-risk pregnant women population. Rev Assoc Med Bras (1992). 2024 Jul 19;70(7):e20240132. doi: 10.1590/1806-9282.20240132. eCollection 2024.

  PMID: 39045936 BACKGROUND

• Laloha F, Asiabar NM, Barikani A, Movahed F, Haj Seyed Javadi E. Effect of Intravenous Dexamethasone on Preparing the Cervix and Labor Induction. Acta Med Iran. 2015;53(9):568-72.

  PMID: 26553085 BACKGROUND

• Mohaghegh Z, Faal Siahkal S, Bahmaei H, Sharifipour F, Leyli EK, Zahedian M. The effect of dexamethasone on labor induction: a systematic review. BMC Pregnancy Childbirth. 2021 Aug 17;21(1):563. doi: 10.1186/s12884-021-04010-1.

  PMID: 34404372 BACKGROUND

• Kavanagh J, Kelly AJ, Thomas J. Corticosteroids for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD003100. doi: 10.1002/14651858.CD003100.pub2.

  PMID: 16625570 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; Injections, Intramuscular; Misoprostol

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Abdelfatah M Eldesouky, MD, MRCOG

CONTACT

00201003370784; a.f.dessouki@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Model Details: 1. Group A: They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL). 2. Group B: They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h. 3. Group C: They 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. * Regarding group A,B and C we will wait 24hrs after the last dose, then reassessment by senior obstetrician will be done and if induction is unsuccessful it'll be determined whether the patient is for either CS or second 24hr attempt at induction by misoprostol.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 7, 2025
• Study Start: May 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Locations

EG (1)