Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-07-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cook catheter

Control

Group Type OTHER

Cook catheter

Intervention Type DEVICE

Cook catheter plus low dose oxytocin

Test group

Group Type ACTIVE_COMPARATOR

Cook catheter

Intervention Type DEVICE

Oxytocin

Intervention Type DRUG

Interventions

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Cook catheter

Intervention Type DEVICE

Oxytocin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes