Status:
COMPLETED
Induction With Foley OR Misoprostol (INFORM) Study
Lead Sponsor:
University of Liverpool
Collaborating Sponsors:
Gynuity Health Projects
Government Dental College and Hospital, India
Conditions:
Pre-eclampsia
Fetus or Newborn; Effects of Induction of Labor
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The o...
Detailed Description
This is a pragmatic, open-label, randomised control trial of two methods for labour induction among women with pre-eclampsia. Women requiring delivery for preeclampsia in two hospitals in Nagpur, Indi...
Eligibility Criteria
Inclusion
- Ongoing pregnancies with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grounds or would be considered or not.
- Women age ≥18 years
- Signed informed consent form
Exclusion
- • Women with previous caesarean sections
- Those unable to give informed consent
- Multiple pregnancy
- History of allergy to misoprostol
- Ruptured membranes
- Chorioamnionitis (by clinical diagnosis)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT01801410
Start Date
December 1 2013
End Date
June 1 2015
Last Update
December 14 2015
Active Locations (2)
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1
Daga Memorial Women's Hospital
Nagpur, Maharashtra, India
2
Government Medical College (GMC)
Nagpur, India