Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Henry Ford Health

Status: Completed

Conditions: Cervical Ripening

Treatments: Drug: Oxytocin; Device: Cook catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02465164

HFM 2900

Details and patient eligibility

About

The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in conjunction with low dose oxytocin is more effective at shortening labor induction times than the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by either Resident or Attending Physicians and left in place for 12 hours (protocol) in both groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will be used for the remainder of the induction per current hospital protocol. Time to delivery, mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be recorded.

Enrollment: 26 patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. singleton pregnancy
2. reassuring fetal status at time of presentation
3. Bishop Score <6

Exclusion criteria

1. Closed cervix
2. Breech presentation
3. Multiple gestations
4. Recent vaginal bleeding
5. Placenta previa
6. non reassuring fetal status
7. Active genital herpes infection

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Cook catheter

Other group

Description:

Control

Treatment:

Device: Cook catheter

Cook catheter plus low dose oxytocin

Active Comparator group

Description:

Test group

Treatment:

Device: Cook catheter

Drug: Oxytocin