Dexamethasone and Induction of Delivery

NCT03658590 | Completed Phase 1 FDA Drug

• 1 other identifier: 100
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of intravenous injection of a single dose of dexamethasone in shortening the duration interval between initiation of labor induction and delivery of the fetus in primigravida full-term pregnancy.

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• The interval between the initiation of induction and the delivery of the fetus.

  Mean time of interval between the initiation of induction and the delivery of the fetus in the two groups.

  Up to 1 day

Secondary Outcomes (5)

• The duration of the first stage of labor (Partographic representation will do for each participant).

  Up to 1 hour

• The duration of the second stage of labor.

  Up to 2 hours

• The duration of the third stage of labor.

  Up to 30 minutes

• The neonatal outcome by APGAR score.

  at 1 and 5 minutes

• Any postpartum maternal adverse effects (e.g. vital sing abnormality, any maternal postpartum hemorrhage and central nervous system manifestation).

  Up to 1 day

Study Arms (2)

Group D

ACTIVE COMPARATOR

including 51 women who will receive a prefilled syringe with two milliliters (8 mg) of dexamethasone intravenously.

Drug: Dexamethasone

Group P

PLACEBO COMPARATOR

including 51 women who will receive a prefilled syringe with two milliliters of distilled water intravenously.

Drug: Distilled Water

Interventions

Dexamethasone DRUG

a prefilled syringe with two milliliters (8 mg) of dexamethasone intravenously

Also known as: Drug group

Group D

Distilled Water DRUG

a prefilled syringe with two milliliters of distilled water intravenously.

Also known as: Placebo group

Group P

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparity
• Singleton pregnancy
• Gestational age i.e. 40 weeks or more by date or 1sttrimestric ultrasound.
• Bishop score of 4 or greater.
• Longitudinal lie.
• Vertex presentation.
• Intact membranes

You may not qualify if:

• Refused consent
• Malpresentation.
• Multiple pregnancies.
• Active phase of labour.
• Rupture of membranes (ROM).
• Cephalo-pelvic disproportion.
• Previous C-section or myomectomy operation.
• Known contraindication or hypersensitivity to Dexamethasone.
• Fetal distress.
• IUFD
• Current maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension.
• Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound.
• Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage.

Sponsors & Collaborators

• samar sayed el sayed: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Tarek F Tamara, MD

  Ain Shams University

  STUDY CHAIR

• Amgad E Abou Gamrah, MD

  Ain Shams University

  STUDY DIRECTOR

• Gihan E Elhawwary, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecologist and Obstetrician

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: January 1, 2018
• Primary Completion: April 15, 2018
• Study Completion: June 30, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

EG (1)