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Completed

NCT Number: NCT00468520

Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

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Key information

Conditions

Pregnancy Cervical Ripening Induced Labor

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10068, United States

About this study

This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • singleton gestation
  • presenting for induction as determined by their primary obstetrical provider
  • with fetuses in cephalic presentation
  • gestational age greater than 23 weeks

Exclusion criteria

  • any condition precluding vaginal delivery
  • estimated fetal weight >4500 grams
  • a previous attempt at ripening or induction during the pregnancy
  • clinically significant cervical or vaginal infection
  • chorioamnionitis
  • HIV
  • hepatitis B or C
  • unexplained vaginal bleeding
  • low-lying placenta
  • abnormal cervical anatomy or cervical cerclage
  • latex allergy

Treatment and study plan

Low dose oxytocin

Drug

Primary outcomes

  1. Delivery rate (proportion)

    Time frame: Within 24 hours

Secondary outcomes

  1. vaginal delivery rate

    Time frame: within 24 hours

  2. use of anesthesia/analgesia

    Time frame: during induction and labor

  3. overall complication rate (composite)

  4. duration of induction and labor

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening

Important dates

Study start
2003
Study completion
2005
First posted
May 2, 2007
Registry last updated
Mar 2, 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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