NCT01866488

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

3.5 years

First QC Date

April 30, 2013

Last Update Submit

August 27, 2016

Conditions

Labor Induction

Keywords

Labor inductionMisoprostolCytotecCook Obstetric Double Balloon Catheter

Outcome Measures

Primary Outcomes (1)

  • Occurence of cesarean section

    Within 96 hours from the commencement of the Induction of Labor

Secondary Outcomes (1)

  • Time from start of induction of labor to vaginal delivery

    24, 48 and 72 hours

Other Outcomes (1)

  • Change in cervical bishop score with allotted treatment

    6 hours

Study Arms (2)

Cook Catheter, Oral Misoprostol

EXPERIMENTAL

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

Drug: Misoprostol

Cook Catheter, Oral Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MisoprostolDRUG
Also known as: Cytotec
Cook Catheter, Oral Misoprostol
PlaceboOTHER
Cook Catheter, Oral Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \. 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.
  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85718, United States

RECRUITING

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Meg Hill, MBBS

    University of Arizona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meg Hill, MBBS

CONTACT

520 626 6174meg.hill@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Maternal Fetal Medicine

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 31, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

US(1)