Induction With Foley OR Misoprostol (INFORM) Study

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liverpool
• Collaborators: Daga Memorial Women's Hospital, Nagpur, India; Government Dental College and Hospital, India; Gynuity Health Projects
• Treatments: Misoprostol

Criteria

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)