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

Last updated: February 9, 2018
Sponsor: Oihane Lapuente Ocamica
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02902653
DV-MV-MO
  • Ages 18-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 372
Study Start date:
September 01, 2016
Estimated Completion Date:
September 30, 2020

Connect with a study center

  • Araba University Hospital

    Vitoria-Gasteiz, Basque Country 01009
    Spain

    Active - Recruiting

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