Role Of Dexamethasone In Induction Of Labor

NCT03603418 | Unknown Phase 4

• 1 other identifier: 292017
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dexamethasone Effect on Induction of Labor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Induction active phase interval

  It may vary from 2 to 3 hours up to 48 hours

Study Arms (2)

Group D (Study group-Dexamethasone group)

EXPERIMENTAL

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

Group C (Control group)

PLACEBO COMPARATOR

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

Interventions

Dexamethasone Sodium Phosphate DRUG

Dexamethasone is a synthetic glucocorticoid that is commonly used in human medical practice as potent anti-inflammatory, immunosuppressive and analgesic agent.

Group D (Study group-Dexamethasone group)

Distilled water OTHER

Distilled water

Group C (Control group)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 02020, Egypt

RECRUITING

MeSH Terms

Interventions

dexamethasone 21-phosphate

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ObGyn Resident

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 27, 2018
• Study Start: July 13, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

EG (1)