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Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction

O

Oihane Lapuente Ocamica

Status and phase

Unknown
Phase 4

Conditions

Labor, Induced

Treatments

Drug: Vaginal misoprostol
Drug: Oral misoprostol
Drug: Vaginal dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT02902653
DV-MV-MO

Details and patient eligibility

About

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.

Enrollment

372 estimated patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

372 participants in 3 patient groups

Oral misoprostol
Experimental group
Description:
Administration of oral misoprostol according to a "3x1" diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment
Treatment:
Drug: Oral misoprostol
Vaginal misoprostol
Active Comparator group
Description:
vaginal misoprostol, 25 microgs every 4 hours
Treatment:
Drug: Vaginal misoprostol
Vaginal dinoprostone
Active Comparator group
Description:
vaginal dinoprostone, 10 mg during 24 hours (maximum)
Treatment:
Drug: Vaginal dinoprostone

Trial contacts and locations

1

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Central trial contact

Amanda Lopez Picado; Oihane Lapuente Ocamica

Data sourced from clinicaltrials.gov

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