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

Labor, Induced Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02902653
• Other study ID #: DV-MV-MO
• Status: Recruiting
• Phase: Phase 4
• First received: September 7, 2016
• Last updated: February 9, 2018
• Start date: September 2016
• Est. completion date: September 2020

Study information

• Verified date: February 2018
• Source: Basque Health Service
• Contact: Oihane Lapuente Ocamica
• Email: OIHANE.LAPUENTEOCAMICA[@]osakidetza.eus
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 372
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor, Induced

Intervention

Drug:
• Oral misoprostol
hourly titrated misoprostol
• Vaginal misoprostol
Administration of 25 microgs every 6 hours, maximum 150 microgr
• Vaginal dinoprostone
Vaginal delivery system of 10mg of dinoprostone

Locations

Country	Name	City	State
Spain	Araba University Hospital	Vitoria-Gasteiz	Basque Country

Sponsors (1)

Lead Sponsor	Collaborator
Oihane Lapuente Ocamica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group		12 hours
Secondary	The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group		24 hours
Secondary	The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group		12 hours
Secondary	Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)		24 hours
Secondary	The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)		24 hours
Secondary	Compare the percentage of women requiring oxytocin in each group		24 hours
Secondary	The percentage of women in each group having tachysystole		24 hours
Secondary	Compare the number of women suffering from uterine rupture in each group		24 hours
Secondary	The percentage of women in each branch having uterine hypertonia		24 hours
Secondary	Maternal morbility-mortality among pregnant participants		up to 180 days
Secondary	Compare fetal or neonatal morbility-mortality among the 3 groups		up to 180 days