Induction With Foley OR Misoprostol (INFORM) Study
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Liverpool
Collaborators:
Daga Memorial Women's Hospital, Nagpur, India Government Dental College and Hospital, India Gynuity Health Projects