NCT01140971

Brief Summary

PURPOSE: The purpose of this study is to determine the effectiveness of balloon dilatation (Foley) with vaginal misoprostol for cervical ripening and induction of labor. METHOD: a randomized clinical assay has been performed with 160 women with indication of induction of labor, randomly divided in two groups, 80 for Foley catheter and 80 for misoprostol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

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

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
Last Updated

June 10, 2010

Status Verified

September 1, 2009

Enrollment Period

2.2 years

First QC Date

June 8, 2010

Last Update Submit

June 9, 2010

Conditions

Pregnancy, ProlongedPre EclampsiaOligohydramnios

Keywords

Balloon dilatation,misoprostol,cervical ripening,obstetric labor,labor induced.

Outcome Measures

Primary Outcomes (1)

  • Cervical ripening

    Foley Group: catheter stay no more that 48 hours. Every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications. Misoprostol group: was introduced 25 microgram every 6 hour (max 200microg)if cervical conditions were unchanged. In the case of cervical evolution or start of labour the method was considered success.The failure was adopted if after 48 there was no cervical modifications.

    48 hous after start the method

Secondary Outcomes (3)

  • Cesarean

    The action of methods were assessed for 48 hours after start.

  • Need of oxytocin

    48 hours after start method

  • need of neonatal intensive care

    7 first days after birth

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Use 25 micrograms vaginal every 6 hours (max dosis 200 micrograms in 48 hours)

Drug: Misoprostol

Foley

ACTIVE COMPARATOR

Foley catheter number 14 or 16 was installed intracervical for no more than 48 hours.

Device: Foley

Interventions

MisoprostolDRUG

Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more

Also known as: Prostokos 25 micrograms
Misoprostol
FoleyDEVICE

After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.

Foley

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Gestational age from 37 weeks,
  • feto unic, alive and cephalic,
  • Bishop index equal or lesser than four.

You may not qualify if:

  • uterine scar,
  • premature rupture of the membranes,
  • fetal weight bigger than 4000 g,
  • previous placenta,
  • conditions that imposed the immediate ending of the gestation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MHVNCachoeirinha

São Paulo, São Paulo, 02720-200, Brazil

Location

Related Publications (3)

  • Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001 Nov;98(5 Pt 1):751-6. doi: 10.1016/s0029-7844(01)01579-4.

    PMID: 11704164BACKGROUND

  • Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2.

    PMID: 15919393BACKGROUND

  • Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.

    PMID: 11687101BACKGROUND

MeSH Terms

Conditions

Pregnancy, ProlongedPre-EclampsiaOligohydramnios

Interventions

MisoprostolUrinary Catheterization

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsDiagnostic Techniques, UrologicalDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Study Officials

  • Nelson Sass, pHD

    Maternidade Escola de Vila Nova Cachoeirinha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2010

First Posted

June 10, 2010

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

January 1, 2009

Last Updated

June 10, 2010

Record last verified: 2009-09

Locations

BR(1)