Completed

INFORMInduction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol

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What is being tested

Misoprostol

+ Foley Catheter

DrugDevice
Who is being recruted

Urogenital Diseases+2

+ Female Urogenital Diseases and Pregnancy Complications

+ Pregnancy Complications

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorUniversity of Liverpool
Last updated: December 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01801410
Principal SponsorUniversity of Liverpool
Last updated: December 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

602 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsHypertension, Pregnancy-InducedPre-Eclampsia

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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Group II

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).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Daga Memorial Women's Hospital

Nagpur, IndiaOpen Daga Memorial Women's Hospital in Google Maps

Government Medical College (GMC)

Nagpur, India
Completed2 Study Centers