Clinical trial NCT02902653: Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction
Official title: Efficacy and Safety of Hourly Titrated Misoprostol Versus Vaginal Dinoprostone and Misoprostol for Cervical Ripening and Labor Induction: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor, Induced
Keywords: misoprostol
dinoprostonal
induction
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2016-09-16
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 24 hours
Secondary outcomes:
measure: The number of women who manage cervical favorable conditions at 12 hours after the beginning of administration in each group
timeFrame: 12 hours
measure: The number of women who manage cervical favorable conditions at 24 hours after the beginning of administration in each group
timeFrame: 24 hours
measure: The percentage of women in each group who achieved vaginal delivery at 12 hours after the beginning of administration in each group
timeFrame: 12 hours
measure: Compare the number of women who achieve a vaginal delivery in the 3 groups (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
timeFrame: 24 hours
measure: The number of caesarean sections in each group (oral misoprostol, vaginal misoprostol and intravaginal dinoprostone)
timeFrame: 24 hours
measure: Compare the percentage of women requiring oxytocin in each group
timeFrame: 24 hours
measure: The percentage of women in each group having tachysystole
timeFrame: 24 hours
measure: Compare the number of women suffering from uterine rupture in each group
timeFrame: 24 hours
measure: The percentage of women in each branch having uterine hypertonia
timeFrame: 24 hours
measure: Maternal morbility-mortality among pregnant participants
timeFrame: up to 180 days
measure: Compare fetal or neonatal morbility-mortality among the 3 groups
timeFrame: up to 180 days
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Araba University Hospital
state: Basque Country
Study officials:
affiliation: OIHANE.LAPUENTEOCAMICA@osakidetza.eus
name: Oihane Lapuente Ocamica
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lapuente-Ocamica O, Ugarte L, Lopez-Picado A, Sanchez-Refoyo F, Lasa IL, Echevarria O, Alvarez-Sala J, Farinas A, Bilbao I, Barbero L, Vicarregui J, Hernanz Chaves R, Paz Corral D, Lopez-Lopez JA. Efficacy and safety of administering oral misoprostol by titration compared to vaginal misoprostol and dinoprostone for cervical ripening and induction of labour: study protocol for a randomised clinical trial. BMC Pregnancy Childbirth. 2019 Jan 8;19(1):14. doi: 10.1186/s12884-018-2132-3.