NCT02902653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
372

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

September 7, 2016

Last Update Submit

February 9, 2018

Conditions

Labor, Induced

Keywords

misoprostoldinoprostonalinduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (3)

Oral misoprostol

EXPERIMENTAL

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

Vaginal misoprostol

ACTIVE COMPARATOR

vaginal misoprostol, 25 microgs every 4 hours

Drug: Vaginal misoprostol

Vaginal dinoprostone

ACTIVE COMPARATOR

vaginal dinoprostone, 10 mg during 24 hours (maximum)

Drug: Vaginal dinoprostone

Interventions

Oral misoprostolDRUG

hourly titrated misoprostol

Oral misoprostol
Vaginal misoprostolDRUG

Administration of 25 microgs every 6 hours, maximum 150 microgr

Vaginal misoprostol
Vaginal dinoprostoneDRUG

Vaginal delivery system of 10mg of dinoprostone

Vaginal dinoprostone

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Araba University Hospital

Vitoria-Gasteiz, Basque Country, 01009, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30621614DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Oihane Lapuente Ocamica

    OIHANE.LAPUENTEOCAMICA@osakidetza.eus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oihane Lapuente Ocamica

CONTACT

OIHANE.LAPUENTEOCAMICA@osakidetza.eus

Amanda Lopez Picado

CONTACT

amanda.lopezpicado@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 16, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

ES(1)