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Misoprostol Labour Induction Study

NCT03489928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2018-04-06

No results posted yet for this study

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

Interventions

DRUG

Oral Misoprostol

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

DRUG

Vaginal Misoprostol

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

DRUG

Dinoprostone

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

Sponsors & Collaborators

  • David Young

    lead OTHER

Principal Investigators

  • David C Young, MD MSc FRCSC · IWK Health Centre

  • B A Armson, MD MSc FRCSC · IWK Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-04-01
Primary Completion
2000-12-01
Completion
2000-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489928 on ClinicalTrials.gov