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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

NCTNCT02465164 (opens ClinicalTrials.gov in a new tab)Other idHFM 2900
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
26 participants (actual)
Sponsor
Henry Ford Health System · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
1 Jul 2015
Primary completion
30 Jul 2016
Completion
30 Jul 2016
First posted
8 Jun 2015 (estimated)
Last update posted
22 May 2023
Conditions
Cervical Ripening

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. N/A

    Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin

    NCT02465164

    1 Jul 2015 to 30 Jul 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Cook catheterDevice
  • OxytocinDrug

Arms2

  • Other

    Cook catheter

    Control

  • Active comparator

    Cook catheter plus low dose oxytocin

    Test group

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to Delivery (in Hours)

    Time frame · Up to 60 hours

    Registry description

    Cook Only group Cook + Pitocin group N Mean (hrs) (SD) 16 27.9 (9.6) 10 23 14.6)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Up to 60 hours

Time to Delivery (in Hours)

GroupValue (hours)
Cook Catheter27
Cook Catheter Plus Low Dose Oxytocin23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cook CatheterControl Cook catheter0 / 160 / 160 / 16
Cook Catheter Plus Low Dose OxytocinTest group Cook catheter Oxytocin0 / 100 / 100 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 16 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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