Clinical trial NCT01801410: Induction With Foley OR Misoprostol (INFORM) Study
Official title: Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pre-eclampsia
Fetus or Newborn; Effects of Induction of Labor
Keywords: pre-eclampsia
labor induction
misoprostol
Foley catheter
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
name: Government Dental College and Hospital, India
name: Daga Memorial Women's Hospital, Nagpur, India
First posted: 2013-02-28
Enrollment: 602
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Attainment of vaginal delivery within 24 hours.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Memorial Women's Hospital
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College (GMC)
Study officials:
affiliation: University of Liverpool
name: Andrew D Weeks, MD FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mundle S, Bracken H, Khedikar V, Mulik J, Faragher B, Easterling T, Leigh S, Granby P, Haycox A, Turner MA, Alfirevic Z, Winikoff B, Weeks AD. Foley catheterisation versus oral misoprostol for induction of labour in hypertensive women in India (INFORM): a multicentre, open-label, randomised controlled trial. Lancet. 2017 Aug 12;390(10095):669-680. doi: 10.1016/S0140-6736(17)31367-3. Epub 2017 Jun 28.
citation: Bracken H, Mundle S, Faragher B, Easterling T, Haycox A, Turner M, Alfirevic Z, Winikoff B, Weeks A. Induction of labour in pre-eclamptic women: a randomised trial comparing the Foley balloon catheter with oral misoprostol. BMC Pregnancy Childbirth. 2014 Sep 5;14:308. doi: 10.1186/1471-2393-14-308.