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Induction With Foley OR Misoprostol (INFORM) Study | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT01801410

Induction With Foley OR Misoprostol (INFORM) Study

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...

Lead sponsor: University of Liverpool•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Liverpool

Collaborators

Gynuity Health Projects
Government Dental College and Hospital, India
Daga Memorial Women's Hospital, Nagpur, India

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, India will be randomised to one of two treatment groups: transcervical Foley catheter or oral misoprostol tablets.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•• Women with previous caesarean sections
•* Those unable to give informed consent
•* Multiple pregnancy
•* History of allergy to misoprostol
•* Ruptured membranes
•* Chorioamnionitis (by clinical diagnosis)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 14, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment602

Start dateDec 2013

Last updatedDec 14, 2015

Condition

Pre-eclampsia Fetus or Newborn; Effects of Induction of Labor

Locations shown

Daga Memorial Women's Hospital

Nagpur, Maharashtra

Government Medical College (GMC)

Nagpur

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 14, 2015Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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