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Status unknownNCT02508402Updated Feb 1, 2016

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

A Phase 4 interventional study of Dexamethasone and Placebo in Medical Induction of Labor Affecting Fetus, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-01.

Sponsored by Kasr El Aini Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

METHODS:

This retrospective clinical trial was conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, during the period from August 2014 to May 2015. The study protocol was approved by the Scientific Research Committee, and informed consent was obtained from all participants.

Each participant will randomly be assigned by computer list into Group I (Dexamethasone group(n=43)and group II(control group(N=43).

No cervical ripening agent will be used for induction of labour in the trial.

Methodology in details:

I. The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of placebo Group will not receive Dexamethasone or any other cervical ripening agent.

All the participants in both groups will randomly be assigned by computer list. (Haijavandi et., al 2013)

II. After six hours of the initial dose, the labour induction will start via Oxytocin using the following protocol:

  1. Initial dose of oxytocin.................................. 1 to 2 milliliter international unit/min.
  2. Increase interval......................................................30 minutes.
  3. Dosage increment....................................................1 to 2 milliliter international unit/min.
  4. Usual dose for good labour.........................8 to12 milliliter international unit/min.
  5. Maximum dose........................................30 milliliter international unit/min. (Anne Biringer et., al 2013).

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).

IV. Partographic representation for progression of active phase labour:

  1. Frequency and duration of uterine contraction.
  2. Cervical dilatation will record every two hours by per vaginal examination.
  3. Station and position of fetal head was noted at the same time.

V. After delivery:-

  1. The duration of the first stage of labor will be recorded. (Partographic representation will do for each participant).
  2. The duration of the second stage of labor will be recorded.
  3. The duration of the placental separation will be recorded.
  4. The neonatal outcome will be recorded by APGAR score.
  5. Any postpartum maternal adverse effect was noted (e.g. vital sign abnormality, any maternal postpartum hemorrhage).

Primary outcome:

the duration between induction and beginning of active phase.

Secondary outcome:

-Duration of first stage.

02

Conditions studied

  • Medical Induction of Labor Affecting Fetus
03

In context

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (estimated)

Study arms

  • Active comparator
    dexamethasone group

    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 comparator
    Placebo group

    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

  • DrugDexamethasone

    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

  • DrugPlacebo

    two milliliters of normal saline given to placebo group .

    Also known as: Normal saline

06

What researchers measure

Primary outcomes

  1. the duration between induction and beginning of active phase.

    Time frame: 6 months

Secondary outcomes

  1. Duration of first stage.

    Time frame: 7 months

07

Study locations

1 site
  • Mohamed Abdel Aziz El Sharkawy
    Cairo, 12345, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02508402
Lead sponsor
Kasr El Aini Hospital
Responsible party
Mohamed El-Sharkawy (Lecturer of obstetrics and gynecology, Kasr El Aini Hospital) — Principal investigator
First posted
Jul 24, 2015
Start date
Sep 2015
Primary completion
Jul 2016 (estimated)
Completion
Jul 2016 (estimated)
Last update
Feb 1, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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