Induction With Foley OR Misoprostol (INFORM) Study

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.

Conditions

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

Interventions

DEVICE

Foley Catheter

Transcervical Foley catheter (silicone, size 18F with 30ml balloon)

DRUG

Misoprostol

25mcg every 2 hours for maximum of 12 doses

Sponsors & Collaborators

• Gynuity Health Projects

  collaborator OTHER

• Government Dental College and Hospital, India

  collaborator OTHER_GOV

• Daga Memorial Women's Hospital, Nagpur, India

  collaborator OTHER

• University of Liverpool

  lead OTHER

Principal Investigators

• Andrew D Weeks, MD FRCOG · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-31

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• India

Study Locations