Induction With Foley OR Misoprostol (INFORM) Study

NCT ID: NCT01801410

Last Updated: 2015-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 602 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

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

Keywords

pre-eclampsia; labor induction; misoprostol; Foley catheter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol

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).

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

25mcg every 2 hours for maximum of 12 doses

Foley Catheter

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).

Group Type: ACTIVE_COMPARATOR

Foley Catheter

Intervention Type: DEVICE

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

Interventions

Foley Catheter

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

Intervention Type: DEVICE

Misoprostol

25mcg every 2 hours for maximum of 12 doses

Intervention Type: DRUG

Other Intervention Names

Cervical ripening balloon, balloon catheter; Cytotec

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gynuity Health Projects

OTHER

Sponsor Role: collaborator

Government Dental College and Hospital, India

OTHER_GOV

Sponsor Role: collaborator

Daga Memorial Women's Hospital, Nagpur, India

OTHER

Sponsor Role: collaborator

University of Liverpool

OTHER

Sponsor Role: lead

Responsible Party

Andrew Weeks MD MRCOG

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew D Weeks, MD FRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Daga Memorial Women's Hospital

Nagpur, Maharashtra, India

Government Medical College (GMC)

Nagpur, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 28668289 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25193157 (View on PubMed)

Other Identifiers

4001

Identifier Type: -

Identifier Source: org_study_id