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OpenTrials
Completed

NCT Number: NCT02842879

Outpatient Foley Cervix Priming

The aim was to conduct a non-blinded prospective randomized study at a tertiary hospital. Inclusion criteria: term pregnancy with a single fetus in cephalic presentation, Bishop score < 6, gestational age > 41 weeks or medical indication for induction of labor.

Patients will be randomized to outpatient or inpatient cervix priming with Foley catheter.

The primary outcome will be to compare the variation of Bishop score (difference between Bishop score before and after application of Foley catheter) between outpatient and inpatient groups. Secondary comparisons include: mode of delivery, Foley catheter application-to-delivery time, inpatient time, sequential use of prostaglandins, infection and maternal pain.

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Key information

Conditions

Outpatient Mechanical Cervix Priming

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women with a single fetus in cephalic presentation
  • Bishop score < 6
  • Gestational age > 41 weeks or medical indication for induction of labor submitted to cervix priming with Foley catheter

Exclusion criteria

  • women with a fetus in noncephalic presentation
  • an indication for elective cesarean delivery
  • spontaneous labor
  • hydramnios (amniotic fluid index ≥ 25)
  • nonreassuring cardiotocogram
  • multiple pregnancy
  • rupture of membranes
  • active vaginal bleeding
  • indication for prophylaxis of Streptococcus group B infection
  • HIV infection
  • cervical injury
  • previous cesarean section with recurrent indication

Treatment and study plan

Outpatient Foley cervix priming

Other

Outpatient setting for cervix priming with Foley catheter

Primary outcomes

  1. variation of bishop score (difference between bishop score before and after application of foley catheter)

    Time frame: up to 24 months

Secondary outcomes

  1. mode of delivery

    Time frame: up to 24 months

  2. induction-to-delivery time

    Time frame: up to 24 months

  3. maternal pain evaluated by visual analog scale for pain

    Time frame: up to 24 months

Sponsors and collaborators

Lead sponsor

Hospital de Santa Maria, Portugal

Other

Registry information

Official study title

Outpatient Versus Inpatient Cervix Priming With Foley Catheter

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2016
Registry last updated
Jul 25, 2016

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.