Effect of Dexamethasone on Labour Induction in Term Pregnancies
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- The interval between initiation of induction and beginning of the active phase of labour.
Study Overview
Brief Summary
The aim of the study is to assess the effect of dexamethasone on labour induction in term pregnancies.
Primary outcome:
The interval between initiation of induction and beginning of the active phase of labour.
Secondary outcomes:
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).
- Duration of second stage of labour
- Mode of delivery.
- Fetal outcome.
Group A:
Will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
Group B:
Will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Group C:
Will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Detailed Description
- Study type: Randomized Controlled Trial
- Population of study:
Pregnant women above 18 years of age, eligible for induction of labour.
● Study location: Cairo University Obstetrics & Gynecology Hospital (Kasr Al-Ainy)
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Methodology in details:
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Every subject will be subjected to:
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Written consent.
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Complete history to exclude systemic disorders, congenital fetal malformation and contraindications for vaginal delivery.
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General examination of the patients including pulse, blood pressure and body mass index, [weight (kg)/ height (m2)] (20-25) normal weight, (25-30) overweight, (30-35) obese, (35-40) very obese and >40 morbid obese.
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Abdominal examination including presentation, station of fetal head, fetal heart rate, uterine contractions and exclusion of multiple pregnancies.
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Local examination to determine cervical dilatation at the beginning of intervention, presenting part, station of fetal head, pelvic adequacy and Bishop scoring.
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Sonographic examination including assessment of fetal well-being by biophysical profile.
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Patients will be randomly assigned to three groups using simple randomization via computer-generated random numbers will be used.
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The women will be divided into three groups:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age > 18 years.
- •Nulliparous.
- •Vertex presentation.
- •Singleton pregnancy.
- •Gestational age ≥ 39 weeks according to a reliable date for the last menstrual period or a first-trimester ultrasound evaluation.
- •No contraindication for vaginal delivery.
Exclusion Criteria
- •Indication for cesarean section e. g. Placenta previa, intrauterine growth retardation, non-vertex presentation and previous cesarean section.
- •Maternal medical disorders as diabetes mellitus and severe pre-eclampsia.
- •Preterm labour and preterm rupture of membranes.
- •Gestational age <39 weeks of gestation.
- •Fetal macrosomia > 4kg (estimated by u/s).
Arms & Interventions
Group A
They will receive one dose of IM dexamethasone sodium phosphate 8 mg (2 mL).
Intervention: Dexamethasone (Decadron) 8mg IM injection (Drug)
Group B
They will receive vaginal misoprostol 25 μg tablets every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Intervention: Misoprostol 25 mcg (Drug)
Group C
They will receive one dose of IM dexamethasone sodium phosphate 8mg (2mL) with the first dose of vaginal misoprostol 25 μg tablets that will be given every 6 h, up to 4 tablets, for a maximum duration of 24 h.
Intervention: Both Misoprostol 25 mcg & Dexamethasone 8mg IM injection (Drug)
Outcomes
Primary Outcomes
The interval between initiation of induction and beginning of the active phase of labour.
Time Frame: The interval between initiation of induction and beginning of the active phase of labour, assessed hourly up to 24 hours.
Assessed hourly
Secondary Outcomes
- Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation).(Duration of active phase of labour (starting with cervical dilatation of 4-5 cm up to full cervical dilatation), assessed hourly up to 24 hours.)
- Duration of second stage of labour(Recorded immediately with delivery of the baby)
- Mode of delivery(After induction attempt (24 hours))
- Fetal outcome(At 1 and 5 minutes after delivery)
- Fetal Outcome(Recorded within 24 hours after delivery)
Investigators
Abdelfatah Mohamed Kamel Eldesouky
Lecturer of Obstetrics and Gynecology
Cairo University