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NCT01063244 Clinical Trial

Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

Cervical Ripening Clinical Trial

Official title:
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01063244
Other study ID # SLHN-08-21
Secondary ID
Status Recruiting
Phase Phase 3
First received February 3, 2010
Last updated May 1, 2014
Start date January 2009
Est. completion date December 2015

Study information
Verified date May 2014
Source St. Luke's Hospital, Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

Description:

One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Recruitment information / eligibility
Status Recruiting
Enrollment 70
Est. completion date December 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Term pregnancy scheduled for induction of labor

Exclusion Criteria:

- Preterm pregnancy that require induction for fetal indications

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• foley balloon only
place foley balloon only in cervix
• foley balloon with weight attached
foley balloon with weight attached

Locations
Country Name City State
United States St Luke's Hosptial & Health Network Bethlehem Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
St. Luke's Hospital, Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to effectively ripen cervix to effective cervical ripening Yes
See also
  Status Clinical Trial Phase
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Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT00374621 - Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate N/A
Completed NCT02732522 - Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor Phase 4
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
Recruiting NCT02738177 - Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation Phase 2
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00468520 - Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2