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Induction of Labor in Oligohydramnios

This study is not yet open for participant recruitment.
Verified March 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00815542
First received: December 25, 2008
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  Purpose

When oligohydramnion - decreased amniotic fluid, is diagnosed at term pregnancies, the common practice is to induce labor. Whenever the cervix is not ripened, there are several methods to ripen the cervix, two of which are: mechanical, using a double balloon catheter and pharmacological, with prostaglandins. The aim of the study is to compare those two methods of cervical ripening for patients with significant oligohydramnion at term.

The study will be a prospective randomised trial.


Condition Intervention Phase
Cervical Ripening
 Device: double balloon catheter
Drug: prostaglandins E2
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor. [ Time Frame: during induction of labor, delivery and early post partum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • patients satisfaction [ Time Frame: induction of labor, delivery and early postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: double balloon catheter
Cervical ripening by double balloon catheter
 Device: double balloon catheter
cervical ripening using double balloon catheter
Placebo Comparator: prostaglandins E2
cervical ripening using prostaglandins E2
 Drug: prostaglandins E2
prostaglandins E2 - Intravaginal Propess for 24 hours

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton pregnancy
  • normal pregnancy, well dated, at term
  • un ripened cervix

Exclusion Criteria:

  • previous cesarean section
  • multiple pregnancy
  • intra uterine growth restricted fetus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815542

Contacts
Contact: Tal Biron - Shental, MD 972-577-482716 Biront@clalit.org.il

Locations
Israel
Meir Medial Center Active, not recruiting
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Tal Biron - Shental, MD Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00815542     History of Changes
Other Study ID Numbers: 034-2011-MMC
Study First Received: December 25, 2008
Last Updated: March 22, 2012
Health Authority: Israel: Clalit Health Services

Additional relevant MeSH terms:
Oligohydramnios
Pregnancy Complications
Dinoprostone
Oxytocics
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013