Role Of Dexamethasone In Induction Of Labor

Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial .

Research hypothesis :

In pregnant women undergoing induction of labor, intramuscular injection of dexamethasone may accelerate induction delivery interval.

Research question :

In pregnant women undergoing induction of labor, does intramuscular injection of dexamethasone accelerate induction delivery interval ?

This study aims to assess the effect of intramuscular administration of dexamethasone on the induction delivery interval in full term patients undergoing induction of labor.

Study Overview

• Status: Unknown
• Conditions: Dexamethasone Effect on Induction of Labor
• Intervention / Treatment: Drug: Dexamethasone Sodium Phosphate; Other: Distilled water

Detailed Description

The use of corticosteroids is one of the methods put forward for the strengthening and speeding up the process of labor. After identification of glucocorticoid receptors in human amnion, the role of corticosteroids in starting the process of labor has been studied in numerous studies. Some of them discussed the relation between dexamethasone injection and labor induction but still there is insufficient data. So by the end of this study it may be possible to assess the effect of intramuscular dexamethasone injection on shortening the induction delivery interval.

• Type of Study: Randomized Clinical Double Blind Trial .
• Study Setting: The study will be conducted at Ain Shams Maternity Hospital.
• Study Population: Full term patients who attend to the labor ward in El Demerdash Maternity Hospital and scheduled for induction of labor.
• Sample Size: Sample size was calculated using PASS® version 15.0, setting the power (β) at 0.02 and the significance level (α) at 0.05. Data from previous reports (Kashanian et al., 2008) indicated that mean Induction-Active phase Interval in women receiving 8mg of dexamethasone before induction of labor and controls was 3.09±1.5 and 4.21±1.8 hours respectively. Calculation according to these values produced a minimal sample size of 70 patients to be randomized equally to both groups. Assuming a drop-out rate of 15%, a minimum drop-out inflated enrollment sample size of approximately 80 women will be needed.
• Ethical Considerations: The study will be approved from the Ethical Committee of the Department of Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University. Informed written consent will be taken from all women before recruitment in the study, and after extensive explanation and clear discussion of risks and benefits.
• Study Procedures: A total of 80 women undergoing induction of labor will be included in this study after taking their consent for this clinical trial after full explanation of the trial.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02020
    • Recruiting
    • ain shams University
    • Contact: Ain Shams University; Phone Number: 01123775756; Email: skmabda@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Primipara.
2. Gestational age (39-41) weeks according to Naegele's rule and a first-trimester ultrasound evaluation.
3. Vertex presentation.
4. Singleton fetus.
5. Intact fetal membranes.
6. No contraindication for vaginal delivery.
7. Cervix with a poor Bishop score (4-6).
8. Reactive CTG.
9. Average amount of liquor.

Exclusion Criteria:

1. Indication for cesarean section e.g. CPD, Placenta previa, IUGR, Non vertex presentation and previous cesarean section.
2. Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
3. Active phase of labor (cervical dilatation of 4 cm plus 3 forceful contractions over a ten minute span).
4. Preterm labor and premature rupture of membranes.
5. Multiparous women.
6. Significant vaginal bleeding. Placenta previa, probable placental abruption.
7. Fetal macrosomia>4.5 kg estimated by u/s.
8. Multiple pregnancy.
9. Fetal Distress and Non-reactive CTG.
10. Oligohydramnios.
11. IUGR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group D (Study group-Dexamethasone group); Forty patients undergoing induction of labor will receive 8 mg (2ml) of the product dexamethasone sodium phosphate intramuscular one hour before the initiation of labor induction in the form of epidrone ampoules which is a dexamethasone product from Epico-Egypt, and labor induction will be performed according to the American College of Obstetricians and Gynecologists protocol, i.e, starting by 25 mcg of PGE1 vaginally, in the form of Vagiprost, every 3-6 hours according to patient response, Dexamethasone will be given one hour before the first dose of Vagiprost, when bishop score reaches 6 to 8, oxytocin will be added by 5 drops/minute of 500 cc saline + 5 units of oxytocin with the dose increasing by 5-10 drops / minute every 30 minute till optimal contractions are reached which are three uterine contractions in 10 minutes and each lasting for 40-50 seconds	Drug: Dexamethasone Sodium Phosphate; Dexamethasone is a synthetic glucocorticoid that is commonly used in human medical practice as potent anti-inflammatory, immunosuppressive and analgesic agent.
Placebo Comparator: Group C (Control group); Forty patients undergoing induction of labor will receive 2ml of distilled water intramuscular one hour before the initiation of labor induction, and labor induction will be performed by the same protocol as above.	Other: Distilled water; Distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction delivery interval	The time between beginning of the induction of labor till the end of the 2nd stage of labor	It may vary from 4 to 6 hours up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction active phase interval	The time between beginning of the induction of labor till the beginning of the 1st stage of labor	It may vary from 2 to 3 hours up to 48 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Anticipated): February 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: 292017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No