Induction With Foley OR Misoprostol (INFORM) Study

NCT01801410 | Completed Phase 3 DMC

• 1 other identifier: 4001
• Study Type: interventional
• Target: 602
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

pre-eclampsia; labor induction; misoprostol; Foley catheter

Outcome Measures

Primary Outcomes (1)

• Attainment of vaginal delivery within 24 hours.

  24 hours

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Group 2 will be induced using oral misoprostol tablets (25 mcg) every 2 hours for a maximum of 12 doses or until active labour commences. In primigravid women, if contractions have not commenced after 2 doses, the dosage may be increased to 50mcg every 2 hours. Once in labour (regular painful contractions with a cervical dilatation of at least 4cm) no more misoprostol will be used and artificial membrane rupture and/or oxytocin infusion will be used as clinically indicated. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of repeat misoprostol, Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate).

Drug: Misoprostol

Foley Catheter

ACTIVE COMPARATOR

Group 1 will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) which will remain until active labour starts, the Foley catheter falls out, or 12 hours have elapsed. If the Foley catheter falls out within 12h, membranes will be ruptured and/or oxytocin infusion started. If the Foley catheter does not fall out within 12h, it will be removed at 12h and oxytocin commenced with an artificial rupture of membrane when possible. If labour has still not commenced after 24 hours, they will be deemed to have a 'failed induction' and the decision on further management will be made by the clinical team (their choice could include the use of misoprostol, repeat Foley catheter, dinoprostone, caesarean section or delay as deemed appropriate).

Device: Foley Catheter

Interventions

Foley Catheter DEVICE

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

Also known as: Cervical ripening balloon, balloon catheter

Foley Catheter

Misoprostol DRUG

25mcg every 2 hours for maximum of 12 doses

Also known as: Cytotec

Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with previous caesarean sections
• Those unable to give informed consent
• Multiple pregnancy
• History of allergy to misoprostol
• Ruptured membranes
• Chorioamnionitis (by clinical diagnosis)

Sponsors & Collaborators

• University of Liverpool: lead
• Gynuity Health Projects: collaborator
• Government Dental College and Hospital, India: collaborator
• Daga Memorial Women's Hospital, Nagpur, India: collaborator

Study Sites (2)

Daga Memorial Women's Hospital

Nagpur, Maharashtra, India

Location

Government Medical College (GMC)

Nagpur, India

Location

Related Publications (2)

• 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.

  PMID: 28668289 DERIVED

• 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.

  PMID: 25193157 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Andrew D Weeks, MD FRCOG

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 28, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

IN (2)