Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Induction of Labor in Patients With Unfavorable Cervical Conditions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Hillel Yaffe Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT00604487
First received: January 17, 2008
Last updated: February 10, 2008
Last verified: February 2008
  Purpose

Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. Therefore, over the years, a variety of locally applied pharmacological and physical ripening agents were evaluated. Currently, the commonly utilised local ripening agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or extra-amniotically, systemic absorption of this agent is common, sometimes resulting in uterine hypertonicity, nausea and vomiting. In addition, both induction methods are associated with the initiation of uterine contractions, sometimes lasting for prolonged periods. Therefore a preferred induction method may be a mechanical one which will lead to cervical ripening without causing uterine contractions. Furthermore, there are additional potential advantages of mechanical methods compared to pharmacologic methods such as, ease of storage, low cost and less side effects. A folly catheter, inserted through the cervix, combined with continuous extra-amniotic NS instillation is being used for this purpose for many years. However this method although effective may cause uncomfortable traction of the balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina, occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have recently introduced a newly developed balloon device (Atad Ripener Device), which was designed with one balloon located at the distal end of the device (the uterine balloon, U), while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina provides the traction action and seals the cervix from saline leakage. Another balloon the AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional long tip for instillation of normal to the extra-amniotic space. To the best of our knowledge, no comparison was performed between the use of the double balloon ripener device and folly catheter for induction of labor. Furthermore, there are no published data regarding the use of the double balloon instillation device (AID) combined with continuous extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and side effects of mechanical methods of cervical ripening and labor induction by the double balloon device (ARD), the double balloon instillation device (AID) combined with continuous extra-amniotic instillation of normal saline and the folly catheter combined with continuous extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100 randomised in each arm).


Condition Intervention
Unfavorable Cervix for Induction of Labor
Device: ARD (Atad Ripener Device)
Device: AID (Atad double balloon Instillation Device)
Device: folly catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of the induction methods. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To assess the women's experience and satisfaction with the induction methods. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare the different cervical scoring systems available for predicting a successful induction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Insertion of the Atad double balloon ripener device (100 ml NS in each balloon).
Device: ARD (Atad Ripener Device)
Atad double balloon ripener device
Active Comparator: 2
Insertion of the double balloon instillation device (100 ml NS in each balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
Device: AID (Atad double balloon Instillation Device)
Double balloon instillation device and continuous extra-amniotic instillation of NS 50 Ml/hour
Active Comparator: 3
Insertion of the folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour
Device: folly catheter
folly catheter (40 ml NS in the balloon) and continuous extra-amniotic instillation of NS 50 Ml/hour

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients 15 years of age or older.
  • Diagnosed to be pregnant with an indication for induction of labor.
  • Having a Bishop score of 4 points or less.
  • Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of >28 weeks.
  • Willingness to comply with the protocol for the duration of the study.
  • Have signed an informed consent.

Exclusion Criteria:

  • Any contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation).
  • Ruptured membranes.
  • Previous cesarean section or any uterine scar.
  • Documented labor.
  • Suspected fetal distress necessitating immediate intervention.
  • Proven malignancy of the cervix.
  • Active inflammatory or purulent condition of the lower genital tract.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604487

Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel, 38100
Contact: Osnat Walfisch, MD    972 4 6304248      
Contact: Elad Mei-dan, coordinator    972 4 6304248    eladmei@yahoo.com   
Principal Investigator: Hallak Mordechai, MD         
Sub-Investigator: Elad Mei-dan, M.D.         
Sub-Investigator: Osnat Walfisch, M.D.         
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Mordechai Hallak, M.D. Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT00604487     History of Changes
Other Study ID Numbers: inductionCTIL, no grant
Study First Received: January 17, 2008
Last Updated: February 10, 2008
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Hillel Yaffe Medical Center:
induction
cervix
balloon
Bishop

ClinicalTrials.gov processed this record on November 25, 2014