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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02902653

Enrollment

372

Registered

2016-09-16

Start date

2016-09-30

Completion date

2020-09-30

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Induced

Keywords

misoprostol, dinoprostonal, induction

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.

Interventions

DRUGOral misoprostol

hourly titrated misoprostol

DRUGVaginal misoprostol

Administration of 25 microgs every 6 hours, maximum 150 microgr

DRUGVaginal dinoprostone

Vaginal delivery system of 10mg of dinoprostone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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 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
The percentage of women in each group having tachysystole	24 hours

Countries

Spain

Contacts

Primary ContactOihane Lapuente Ocamica

OIHANE.LAPUENTEOCAMICA@osakidetza.eus

Backup ContactAmanda Lopez Picado

amanda.lopezpicado@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026