Induction With Foley OR Misoprostol (INFORM) Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Liverpool
Sponsor:
Collaborators:
Gynuity Health Projects
Government Dental College and Hospital, India
Daga Women's Hospital, Nagpur India
Information provided by (Responsible Party):
Andrew Weeks MD MRCOG, University of Liverpool
ClinicalTrials.gov Identifier:
NCT01801410
First received: February 14, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Pre-eclampsia
Fetus or Newborn; Effects of Induction of Labor
Device: Foley Catheter
Drug: Misoprostol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol

Resource links provided by NLM:


Further study details as provided by University of Liverpool:

Primary Outcome Measures:
  • Attainment of vaginal delivery within 24 hours. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 602
Study Start Date: July 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Drug: Misoprostol
Active Comparator: 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).
Device: Foley Catheter

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801410

Locations
India
Daga Memorial Women's Hospital
Nagpur, Maharashtra, India
Government Medical College (GMC)
Nagpur, India
Sponsors and Collaborators
University of Liverpool
Gynuity Health Projects
Government Dental College and Hospital, India
Daga Women's Hospital, Nagpur India
Investigators
Principal Investigator: Andrew D Weeks, MD MRCOG University of Liverpool
  More Information

No publications provided

Responsible Party: Andrew Weeks MD MRCOG, Professor, University of Liverpool
ClinicalTrials.gov Identifier: NCT01801410     History of Changes
Other Study ID Numbers: 4001
Study First Received: February 14, 2013
Last Updated: February 27, 2013
Health Authority: United Kingdom: Research Councils UK

Keywords provided by University of Liverpool:
pre-eclampsia
labor induction
misoprostol
Foley catheter

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Eclampsia
Pre-Eclampsia
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 18, 2014