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Completed

NCT Number: NCT01235364

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of obstetrics and gynecology, Uppsala university hospital

Uppsala, 751 85, Sweden

About this study

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 digital cervical examination.

Maternal discomfort/pain during speculum placement of the catheter has been evaluated in a few studies whereas studies that compare the digital method with the speculum method of placement are lacking.

The visual analogue scale is used to subjectively assess pain. With a skin conductance algesimeter an objective assessment of pain is possible.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

foley catheter

Device

The Foley catheter was placed with the digital method

Primary outcomes

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

    Time frame: 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.

    Time frame: During treatment with Foley catheter. At expulsion of Foley catehter

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 5, 2010
Registry last updated
Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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