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

Phase 4

• Conditions: Labor, Induced
• Interventions: Drug: Oral misoprostol; Drug: Vaginal misoprostol; Drug: Vaginal dinoprostone

• Registration Number: NCT02902653
• Lead Sponsor: Oihane Lapuente Ocamica

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-12
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 372

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral misoprostol	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
Vaginal misoprostol	Vaginal misoprostol	vaginal misoprostol, 25 microgs every 4 hours
Vaginal dinoprostone	Vaginal dinoprostone	vaginal dinoprostone, 10 mg during 24 hours (maximum)

Primary Outcome Measures

Name	Time	Method
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)	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Araba University Hospital; 🇪🇸 Vitoria-Gasteiz, Basque Country, Spain