Induction With Foley OR Misoprostol (INFORM) Study

Pre-eclampsia Clinical Trial

— INFORM  

Official title:

Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801410
• Other study ID #: 4001
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2013
• Last updated: December 11, 2015
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2015
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Councils UK
• Study type: Interventional

Clinical Trial 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 only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Foley Catheter
Transcervical Foley catheter (silicone, size 18F with 30ml balloon)

Drug:
• Misoprostol
25mcg every 2 hours for maximum of 12 doses

Locations

Country	Name	City	State
India	Daga Memorial Women's Hospital	Nagpur	Maharashtra
India	Government Medical College (GMC)	Nagpur

Sponsors (4)

Lead Sponsor	Collaborator
University of Liverpool	Daga Memorial Women's Hospital, Nagpur, India, Government Dental College and Hospital, India, Gynuity Health Projects

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attainment of vaginal delivery within 24 hours.		24 hours	Yes