Misoprostol Labour Induction Study

NCT03489928 | Completed Phase 3

• 2 other identifiers: REB#1415051.731.7303088
• Study Type: interventional
• Target: 511
• Locations: 0 countries
• Sites: N/A

Brief Summary

Labour induction is a frequent obstetric intervention (\~20%). Prostaglandins (PGs) are effective agents, but gastrointestinal (GI) intolerance has limited use to non-oral routes. The traditional oxytocin "drip" requires intravenous (IV) use and discourages mobility. Misoprostol, a PG analogue, is marketed for oral treatment of GI disorders, but initiates uterine contraction, an undesirable GI side effect. Recently, there has been a research "boom" on vaginal misoprostol use in pregnancy to induce term labour drawing on this "side effect:". The principal investigator has led one of three groups worldwide which has published on oral misoprostol to study effectiveness, GI tolerance, and safety for mother/baby in term labour induction. Cost per patient has been less then one percent that of other PGs, even less than IV oxytocin.

Conditions

Induction of Labour; Labour, Induced

Keywords

Labour; Induction; Misoprostol; Dinoprostone; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Time interval from induction (at randomization) to vaginal birth

  The chosen clinically important difference: 4 hours (240 minutes) difference. Caesarean sections could not be included in this planned parametric analysis (ANOVA) comparison of means

  Randomization to newborn vaginal birth, assessed through to study completion, up to 10 weeks

Secondary Outcomes (15)

• Time interval from induction (at randomization) to birth

  Randomization to newborn birth, assessed through to study completion, up to 10 weeks

• Profound newborn acidemia

  Cord blood gas sample collected at birth

• Newborn respiratory depression

  Assessed at 5 minutes after birth

• Newborn birth asphyxia

  Birth to newborn hospital discharge, assessed up to 10 weeks

• Newborn severe metabolic acidemia

  Cord blood gas sample collected at birth

Other Outcomes (6)

• Vaginal birth in less than 24 hours

  Randomization to newborn birth, assessed through to study completion, up to 10 weeks

• Time interval from randomization to full dilation

  Randomization to newborn birth, assessed through to study completion, up to 10 weeks

• First stage of labor duration

  Randomization to newborn birth, assessed through to study completion, up to 10 weeks

Study Arms (3)

Oral Misoprostol

EXPERIMENTAL

50ug po q4h orally, as needed

Drug: Oral Misoprostol

Low dose vaginal misoprostol

EXPERIMENTAL

25-50ug q6h, vaginally, as needed

Drug: Vaginal Misoprostol

Usual vaginal dinoprostone

EXPERIMENTAL

1-2mg q6h, vaginally as needed

Drug: Dinoprostone

Interventions

Oral Misoprostol DRUG

Prostaglandin E1 - 100ug tablet, divided in half by pharmacy staff to be administered by mouth.

Also known as: Oral Cytotec

Oral Misoprostol

Vaginal Misoprostol DRUG

Prostaglandin E1 - 100ug oral tablet, divided in quarters by pharmacy staff, vaginal placement of one or two quarters as needed every 6 hours

Also known as: Vaginal Cytotec

Low dose vaginal misoprostol

Dinoprostone DRUG

Prostaglandin E2 - 1-2mg gel manufactured for vaginal use; placed vaginally every 6 hours as needed.

Also known as: Prostin

Usual vaginal dinoprostone

Eligibility Criteria

• Gender Eligibility Details: Women giving birth at the IWK Health Centre
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women
• gestational age 37 weeks or more based on ultrasound before 24 weeks
• live single fetus in cephalic presentation
• indication for induction of labour

You may not qualify if:

• non reassuring fetal heart rate tracing
• maternal prior uterine surgery
• known hypersensitivity to misoprostol or other prostaglandin
• contraindication to vaginal birth
• fetal anomaly identified on antenatal ultrasound
• uncontrolled maternal asthma or epilepsy

Sponsors & Collaborators

• David Young: lead

MeSH Terms

Interventions

Misoprostol; Dinoprostone; KLK15 protein, human

Intervention Hierarchy (Ancestors)

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

Study Officials

• David C Young, MD MSc FRCSC

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

• B A Armson, MD MSc FRCSC

  IWK Health Centre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Group assignment will be concealed until time induction is to begin, when randomization will occur. No attempt will be made at formal blinding of caregivers following concealed randomization, although neonatal assessment will be carried out by a team unaware of study group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Active Staff Physician

Model Details: Patients will be randomly assigned to one of three approaches to initiation of labour induction. Study group allocation will be stratified based on membrane status (ruptured/intact). Sequentially numbered opaque envelopes contain group assignment prepared using computer generated random number tables, in blocks of 4 and 6. Group 1 will receive misoprostol 50µgs, repeated at 4hr intervals until one of the following occurs: progressive labour, contraction frequency of 3 per 10 minutes, non-reassuring fetal heart rate tracing, or delivery. Group 2 will receive misoprostol 25µg initial dose and then 25-50µg placed in the vagina at 6hr intervals to the same effect. Group 3 will have induction of labour managed by the usual method here at the IWK (intravaginal or intracervical prostaglandin gel and IV oxytocin drip). All care decisions will be made by the attending physician. The patient will be reassessed before each administration of misoprostol.

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 6, 2018
• Study Start: April 1, 1999
• Primary Completion: December 1, 2000
• Study Completion: December 1, 2000
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share