Status:
COMPLETED
A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Gynuity Health Projects
Government Medical College, Nagpur
Conditions:
Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is ...
Detailed Description
Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, ...
Eligibility Criteria
Inclusion
- • Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not
- Women age ≥18 years
- Signed informed consent form
- Undergone cervical ripening with misoprostol if cervix initially unfavourable
- Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s
Exclusion
- Women with previous caesarean births
- Those unable to give informed consent
- Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins)
- Multiple pregnancy
- History of allergy to misoprostol
- Adequate uterine activity
- Pre- induction Ruptured amniotic membranes
- Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)
Key Trial Info
Start Date :
January 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT03749902
Start Date
January 6 2020
End Date
July 30 2022
Last Update
December 18 2024
Active Locations (3)
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1
Daga Memorial Women's Hospital
Nagpur, Maharashtra, India
2
Mahatma Gandhi Institute of Medical Sciences
Sevāgrām, Maharashtra, India
3
Government Medical College (GMC)
Nagpur, India