Status:

COMPLETED

Assessment of Pain With Insertion of the Foley Catheter for Induction of Labour

Lead Sponsor:

Uppsala University Hospital

Conditions:

Pain

Eligibility:

FEMALE

18+ years

Phase:

NA

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 w...

Detailed Description

The most common method described for placing the Foley catheter is under direct visualisation of the cervix during a sterile speculum examination. Another method is to place the catheter during a digi...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT01235364

Start Date

August 1 2009

End Date

October 1 2010

Last Update

August 11 2011

Active Locations (1)

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Department of obstetrics and gynecology, Uppsala university hospital

Uppsala, Sweden, 751 85