NCT00992524

Brief Summary

The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 23, 2011

Status Verified

October 1, 2009

Enrollment Period

1.6 years

First QC Date

October 8, 2009

Last Update Submit

June 22, 2011

Conditions

Labor, Induced

Keywords

MisoprostolLabor, ObstetricLabor, Induced

Outcome Measures

Primary Outcomes (5)

  • Vaginal delivery

    24 hours

  • Hyperstimulation syndrome

    24 hours

  • Cesarean section

    3 days

  • Severe neonatal morbidity or perinatal death

    28 days

  • Serious maternal morbidity or maternal death

    42

Secondary Outcomes (18)

  • Need of oxytocin for augmentation of labour

    48 hours

  • Number of doses needed to bring on labour

    48 hours

  • Interval from 1st dose to labour

    48 hours

  • Interval from 1st dose to delivery

    48 hours

  • Failed induction

    72 hours

  • +13 more secondary outcomes

Study Arms (2)

Oral Titrated Misoprostol Solution

ACTIVE COMPARATOR
Drug: Misoprostol

Vaginal Misoprostol

ACTIVE COMPARATOR
Drug: Misoprostol

Interventions

MisoprostolDRUG

Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours.

Also known as: Prostokos, Cytotec
Oral Titrated Misoprostol Solution

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Indication for labour induction
  • Term pregnancy with alive fetus
  • Bishop score less than six

You may not qualify if:

  • Age less than 18 years
  • Previous uterine scar
  • Nonvertex presentation
  • Non-reassuring fetal status
  • Fetal anomalies
  • Fetal growth restriction
  • Genital bleeding
  • Tumors, malformations and/or ulcers of vulva, perineum or vagina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (2)

  • Souza AS, Feitosa FE, Costa AA, Pereira AP, Carvalho AS, Paixao RM, Katz L, Amorim MM. Titrated oral misoprostol solution versus vaginal misoprostol for labor induction. Int J Gynaecol Obstet. 2013 Dec;123(3):207-12. doi: 10.1016/j.ijgo.2013.06.028. Epub 2013 Sep 3.

    PMID: 24112746DERIVED

  • Orange FA, Passini R Jr, Melo AS, Katz L, Coutinho IC, Amorim MM. Combined spinal-epidural anesthesia and non-pharmacological methods of pain relief during normal childbirth and maternal satisfaction: a randomized clinical trial. Rev Assoc Med Bras (1992). 2012 Jan-Feb;58(1):112-7.

    PMID: 22392325DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Alex SR Souza, Phd student

    Professor Fernando Figueira Integral Medicine Institute

    STUDY CHAIR

  • Melania MR Amorim, Phd

    Professor Fernando Figueira Integral Medicine Institute

    STUDY DIRECTOR

  • Aurélio AR Costa, PhD

    Professor Fernando Figueira Integral Medicine Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 23, 2011

Record last verified: 2009-10

Locations

BR(1)