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OpenTrials
Completed

NCT Number: NCT02344459

Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.

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Key information

Conditions

Pre-induction Cervical Ripening

Age range

18 year and older

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

  • Bishop score of 5 or less
  • Singleton
  • Cephalic presentation
  • Fewer than 4 contractions in 10 minutes
  • Reactive fetal monitoring

Exclusion criteria

  • Non-vertex presentation
  • Placenta previa
  • Vasa previa
  • Unexplained vaginal bleeding
  • Active herpes simplex virus infection
  • Non-English speaking
  • Previous attempt at an induction of labor in the current pregnancy
  • Prolapsed umbilical cord
  • More than one prior cesarean delivery or history of classical cesarean delivery
  • Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent

Treatment and study plan

mechanical pre-induction cervical ripening

Device

The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.

Primary outcomes

  1. Bishop score greater than or equal to 6 at time of balloon catheter removal

    Time frame: until catheter removal (12 hours maximum)

Secondary outcomes

  1. induction to delivery time

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  2. vaginal delivery time less than 24 hours from initiation of induction

    Time frame: 24 hours

  3. mode of delivery

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  4. Time to catheter expulsion

    Time frame: Up to 12 hours

  5. Type of catheter expulsion

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

    spontaneous vs. provider

  6. Epidural utilization

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  7. Meconium stained amniotic fluid

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  8. 5 minute Apgar score

    Time frame: The participants infant will be monitored from immediately to 5 minutes after birth

  9. Medication required to augment labor

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

    prostaglandins, oxytocin

  10. Artificial rupture of membranes required to augment labor

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  11. Cesarean section indications

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  12. Neonatal intensive care unit admissions

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  13. Chorioamnionitis

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

  14. birthweight

    Time frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 26, 2015
Registry last updated
Jan 26, 2015

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.