NCT01235364

Brief Summary

The purpose of this study is to assess pain in women randomised to digital or speculum placement of a Foley catheter. Pain during cervical ripening with the Foley catheter is also to be evaluated as well as maternal satisfaction with induction of labour.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 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

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
Last Updated

August 11, 2011

Status Verified

August 1, 2009

Enrollment Period

1 year

First QC Date

November 4, 2010

Last Update Submit

August 10, 2011

Conditions

Pain

Keywords

Foley catheterinductionlabourskin conductancevisual analogue scalemechanical method

Outcome Measures

Primary Outcomes (1)

  • Pain assessed by VAS and SCA, in women randomised to digital or speculum placement of a Foley catheter.

    At insertion of Foley catheter

Secondary Outcomes (1)

  • To assess pain with VAS and SCA during cervical ripening with the Foley catheter and to evaluate maternal satisfaction. To evaluate if markers of stress in blood and amniotic fluid correlate with VAS and SCA.

    During treatment with Foley catheter. At expulsion of Foley catehter

Study Arms (2)

Digital

EXPERIMENTAL

The patient was randomized to digital insertion of the Foley catheter

Device: Foley catheter

Speculum

EXPERIMENTAL
Device: Foley catheter

Interventions

Foley catheterDEVICE

The Foley catheter was placed with the digital method

Digital

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • singleton fetus in cephalic presentation with a Bishop score of 3-5 and
  • indication for induction of labour

You may not qualify if:

  • low-lying placenta,
  • undiagnosed vaginal bleeding,
  • more than one previous caesarean section,
  • previous use of an induction or pre-induction agent during the same pregnancy,
  • signs of infection (maternal fever)
  • non- proficiency in the Swedish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of obstetrics and gynecology, Uppsala university hospital

Uppsala, 751 85, Sweden

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

August 11, 2011

Record last verified: 2009-08

Locations

SE(1)