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

Study Overview
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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.

Official Title
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Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial

Conditions
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Labor, Induced

Intervention / Treatment
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* Drug: Oral misoprostol
* Drug: Vaginal misoprostol
* Drug: Vaginal dinoprostone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral misoprostol<br>Administration of oral misoprostol according to a 3x1 diagram, that is,3 oral doses (1 per hour) and then 1 hour without treatment | Drug: Oral misoprostol<br>* hourly titrated misoprostol<br>|
| Active Comparator: Vaginal misoprostol<br>vaginal misoprostol, 25 microgs every 4 hours | Drug: Vaginal misoprostol<br>* Administration of 25 microgs every 6 hours, maximum 150 microgr<br>|
| Active Comparator: Vaginal dinoprostone<br>vaginal dinoprostone, 10 mg during 24 hours (maximum) | Drug: Vaginal dinoprostone<br>* Vaginal delivery system of 10mg of dinoprostone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group |  | 12 hours | 
| 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 group who achieved vaginal delivery 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 | 
| The number of caesarean sections in each group (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 | 
| The percentage of women in each branch having uterine hypertonia |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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misoprostol, dinoprostonal, induction