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Clinical Trials/NCT02902653
NCT02902653UnknownPhase 4

Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial

Oihane Lapuente Ocamica1 site in 1 country372 target enrollmentStarted: September 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Sponsor
Enrollment
372
Locations
1
Primary Endpoint
Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study evaluates the efficacy and safety of the administration of oral misoprostol versus vaginal dinoprostone and vaginal misoprostol for cervical ripening and labor induction.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Women over 18
  • •single pregnancy
  • •cephalic presentation
  • •intact membranes
  • •unfavorable cervix ( less than 6 Bishop )
  • •CTGR not reactive decelerative
  • •Signed informed consent by the patient.

Exclusion Criteria

  • •prior Cesarean section or previous uterine surgery .
  • •Allergy or intolerance to any of the study drugs
  • •stillbirth
  • •uterine growth restricted fetuses
  • •contraindication for vaginal delivery
  • •Anterior placenta
  • •Multiparity
  • •moderate to severe heart disease
  • •hypertensive disorders of pregnancy
  • •Suspected chorioamnionitis
  • •Coagulation disorders
  • •history of epileptic seizures
  • •liver or kidney disease
  • •Cognitive impairment or bad knowledge of Spanish

Arms & Interventions

Vaginal dinoprostone

Active Comparator

vaginal dinoprostone, 10 mg during 24 hours (maximum)

Intervention: Vaginal dinoprostone (Drug)

Oral misoprostol

Experimental

Administration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment

Intervention: Oral misoprostol (Drug)

Vaginal misoprostol

Active Comparator

vaginal misoprostol, 25 microgs every 4 hours

Intervention: Vaginal misoprostol (Drug)

Outcomes

Primary Outcomes

Compare the percentage of women in each group who achieved vaginal delivery within 24 hours after the beginning of administration in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)

Time Frame: 24 hours

Secondary Outcomes

  • The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group(12 hours)
  • Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)(24 hours)
  • Compare the percentage of women requiring oxytocin in each group(24 hours)
  • The percentage of women in each group having tachysystole(24 hours)
  • Compare the number of women suffering from uterine rupture in each group(24 hours)
  • Maternal morbility-mortality among pregnant participants(up to 180 days)
  • Compare fetal or neonatal morbility-mortality among the 3 groups(up to 180 days)
  • The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group(24 hours)
  • The percentage of women in each branch having uterine hypertonia(24 hours)
  • The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group(12 hours)
  • The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)(24 hours)

Investigators

Sponsor
Oihane Lapuente Ocamica
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Oihane Lapuente Ocamica

Medical Doctor

Basque Health Service

Study Sites (1)

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