Evaluation of the efficacy of labor induction with vaginal misoprostol in a low-risk pregnant women population.
Letícia Sampaio Vilas-Boas, Marcos Paulo Ribeiro Sanches, Edward Araujo Júnior...
https://pubmed.ncbi.nlm.nih.gov/39045936Actively Recruiting
Early Phase 1
Age: 18Years +
FEMALE
Healthy Volunteers
ID07109258
Effect of Dexamethasone on Labour Induction in Term Pregnancies
Led by Cairo University · Updated on 2025-08-07
150
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of dexamethasone on labour induction in women with term pregnancies. This randomized controlled trial includes pregnant women over 18 years old who are eligible for labour induction. The study aims to compare the time from the start of labour induction to the beginning of the active phase, as well as secondary outcomes like duration of active labour, second stage of labour, delivery methods, and fetal outcomes. Participants are randomly divided into three groups. Group A receives one intramuscular dose of dexamethasone sodium phosphate 8 mg (2 mL). Group B receives vaginal misoprostol 25 mcg tablets every 6 hours, up to 4 tablets within 24 hours. Group C receives both the IM dexamethasone dose and the vaginal misoprostol schedule. After dosing, a senior obstetrician reassesses participants 24 hours after the last dose to decide next steps if induction is unsuccessful. During the study, participants undergo detailed medical history and physical exams, including fetal well-being checks and cervical assessments. Researchers monitor labour progress hourly for up to 24 hours, document labour stages, delivery mode, and fetal condition at 1 and 5 minutes after birth. Safety and fetal outcomes are recorded within 24 hours post-delivery. The total participation duration corresponds to the induction process and immediate delivery outcomes.
CONDITIONS
Brief Title
Effect of Dexamethasone on Labour Induction in Term Pregnancies
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- First pregnancy (nulliparous)
- Baby in head-down position (vertex presentation)
- Single pregnancy (not twins or multiples)
- Gestational age 39 weeks or more based on reliable dating
- No contraindications for vaginal delivery
You will not qualify if you...
- Need for cesarean section due to conditions like placenta previa, fetal growth issues, non-head-down position, or prior cesarean
- Maternal medical problems such as diabetes or severe pre-eclampsia
- Preterm labour or preterm rupture of membranes
- Gestational age less than 39 weeks
- Estimated fetal weight over 4 kg (macrosomia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent, medical history, physical and abdominal exams, local and sonographic assessments
Treatment
Duration - Up to 48 hours including induction and reassessment
Participants receive induction of labour using one of three interventions: a single dose of dexamethasone injection, vaginal misoprostol tablets every 6 hours for up to 24 hours, or a combination of both. After the last dose, participants are reassessed for labour progress.
Treatment occurs in hospital with monitoring during induction and reassessment after 24 hours
Follow-up
Duration - Up to 24 hours after delivery
Participants are monitored through delivery to assess labour duration, mode of delivery, and fetal outcomes up to 24 hours after birth.
Assessments at delivery and at 1 and 5 minutes after delivery, plus monitoring within 24 hours postpartum
Trial Site Locations
Total: 1 location
1
Cairo University Hospital (Kasr Al Ainy)
Cairo, Manial, Egypt, 11562
Actively Recruiting
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Research Team
A
Abdelfatah M Eldesouky, MD, MRCOG
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Published Research Related To This Trial
Effect of Intravenous Dexamethasone on Preparing the Cervix and Labor Induction.
Fatemeh Laloha, Negin Mahboob Asiabar, Ameneh Barikani...
https://pubmed.ncbi.nlm.nih.gov/26553085The effect of dexamethasone on labor induction: a systematic review.
Zaynab Mohaghegh, Shahla Faal Siahkal, Hadis Bahmaei...
https://pubmed.ncbi.nlm.nih.gov/34404372Corticosteroids for cervical ripening and induction of labour.
J Kavanagh, A J Kelly, J Thomas
https://pubmed.ncbi.nlm.nih.gov/16625570