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Status unknownNCT01866488Updated Aug 30, 2016

The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

A Phase 2 interventional study of Misoprostol and Placebo in Labor Induction, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-08-30.

Sponsored by University of Arizona · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.

The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.

02

Conditions studied

  • Labor Induction

Keywords

  • Labor induction
  • Misoprostol
  • Cytotec
  • Cook Obstetric Double Balloon Catheter
03

In context

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Single, live fetus
  2. Cephalic (head-first) presentation
  3. Reassuring fetal health assessment
  4. Gestational age between 23 and 42 weeks
  5. Maternal age 18 and above
  6. Bishop score less than 8 in primigravidae
  7. Bishop score less than 6 in multigravidae

Exclusion criteria

Exclusion Criteria:

  1. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.
  1. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Cook Catheter, Oral Misoprostol

    Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours.

    Drug: Misoprostol

  • Placebo comparator
    Cook Catheter, Oral Placebo

    Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours.

    Other: Placebo

Interventions

  • DrugMisoprostol

    Also known as: Cytotec

  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Occurence of cesarean section

    Time frame: Within 96 hours from the commencement of the Induction of Labor

Secondary outcomes

  1. Time from start of induction of labor to vaginal delivery

    Time frame: 24, 48 and 72 hours

Other outcomes

  1. Change in cervical bishop score with allotted treatment

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • University of Arizona
    Tucson, Arizona 85718, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01866488
Lead sponsor
University of Arizona
Responsible party
Meg Hill (Fellow, Maternal Fetal Medicine, University of Arizona) — Principal investigator
First posted
May 31, 2013
Start date
Apr 2013
Primary completion
Oct 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Aug 30, 2016

Study contacts

Meg Hill, MBBS
Contact
meg.hill@hotmail.com
520 626 6174
Meg Hill, MBBS
principal investigator · University of Arizona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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