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

Medical Induction of Labor Affecting Fetus Clinical Trial

Official title:

Effect Of Intra-muscular Administration of Dexamethasone on the Duration of Induction of Labour in Primigravida Post-term Pregnancy.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02508402
• Other study ID #: KasrELAiniH
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 14, 2015
• Last updated: January 29, 2016
• Start date: September 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medical Induction of Labor Affecting Fetus

Intervention

Drug:
• Dexamethasone
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
• Placebo
two milliliters of normal saline given to placebo group .

Locations

Country	Name	City	State
Egypt	Mohamed Abdel Aziz El Sharkawy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration between induction and beginning of active phase.		6 months	Yes
Secondary	Duration of first stage.		7 months	Yes