Effect Of Intra-muscular Administration of Dexamethasone in Induction of Labour

NCT02508402 | Unknown Phase 4 DMC

• 1 other identifier: KasrELAiniH
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT: Objective: To evaluate the efficacy of dexamethasone on labor duration and to establish whether dexamethasone plays a role in shorting the duration interval between initiation of labor induction and beginning of the active phase in primigravida full-term pregnancy. Methods: case control study included 86 primigravidae with full term pregnancy classified into two groups: The participant of Group I will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent. Key Words: Dexamethasone;post-term pregnancy;induction of labor.

Conditions

Medical Induction of Labor Affecting Fetus

Outcome Measures

Primary Outcomes (1)

• the duration between induction and beginning of active phase.

  6 months

Secondary Outcomes (1)

• Duration of first stage.

  7 months

Study Arms (2)

dexamethasone group

ACTIVE COMPARATOR

The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular After six hours of the initial dose, the labour induction will start via Oxytocin .III. The interval between the initiation of induction and the beginning of the active phase of labour is recorded (a cervical dilatation of 4 cm plus 3 forceful contractions over a 10-minute span each last from 40-60 Sec).

Drug: Dexamethasone

Placebo group

PLACEBO COMPARATOR

and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.II.two milliliters of normal saline given.

Drug: Placebo

Interventions

Dexamethasone DRUG

The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent. All the participants in both groups will randomly be assigned by computer list. II. After six hours of the initial dose, the labour induction will start via Oxytocin using

Also known as: epidrone

dexamethasone group

Placebo DRUG

two milliliters of normal saline given to placebo group .

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy.
• Primigravida.
• Post-term gestation i.e. 41 weeks or more.
• Sure, reliable dates.
• Favorable cervix with Bishop score of 7 or greater.
• Longitudinal lie.
• Cephalic presentation (Vertex).

You may not qualify if:

• Abnormal presentation.
• Multigravida.
• Multiple pregnancies.
• Active phase of labour.
• Cephalo-pelvic disproportion.
• History of any medical disorder.
• History of previous myomectomy operation.
• Known contraindication or hypersensitivity to Dexamethasone.
• Current fetal distress.
• Current maternal or fetal disorder e.g. Diabetes mellitus; Pregnancy induced hypertension, and fetal growth retardation.
• Over distended abdomen e.g. fetal macrosomia or polyhydramnios suggested by ultrasound or estimated fetal weight by expert hand.
• Significant vaginal bleeding.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Mohamed Abdel Aziz El Sharkawy

Cairo, 12345, Egypt

Location

MeSH Terms

Interventions

Dexamethasone; Saline Solution

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 24, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 1, 2016

Record last verified: 2015-09

Locations

EG (1)