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

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