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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Labor, Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oral misoprostol

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

Group Type EXPERIMENTAL

Oral misoprostol

Intervention Type DRUG

hourly titrated misoprostol

Vaginal misoprostol

vaginal misoprostol, 25 microgs every 4 hours

Group Type ACTIVE_COMPARATOR

Vaginal misoprostol

Intervention Type DRUG

Administration of 25 microgs every 6 hours, maximum 150 microgr

Vaginal dinoprostone

vaginal dinoprostone, 10 mg during 24 hours (maximum)

Group Type ACTIVE_COMPARATOR

Vaginal dinoprostone

Intervention Type DRUG

Vaginal delivery system of 10mg of dinoprostone

Interventions

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Oral misoprostol

hourly titrated misoprostol

Intervention Type DRUG

Vaginal misoprostol

Administration of 25 microgs every 6 hours, maximum 150 microgr

Intervention Type DRUG

Vaginal dinoprostone

Vaginal delivery system of 10mg of dinoprostone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No