Role Of Dexamethasone In Induction Of Labor

Dexamethasone Effect on Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03603418
• Other study ID #: 292017
• Status: Recruiting
• Phase: Phase 4
• Start date: July 13, 2018
• Est. completion date: February 2019

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dexamethasone Effect on Induction of Labor

Intervention

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.

Other:
• Distilled water
Distilled water

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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