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Induction of Labor in Oligohydramnios

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00815542
First Posted: December 30, 2008
Last Update Posted: March 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]

Secondary Outcome Measures:
  • patients satisfaction [ Time Frame: induction of labor, delivery and early postpartum ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00815542     History of Changes
Other Study ID Numbers: 034-2011-MMC
First Submitted: December 25, 2008
First Posted: December 30, 2008
Last Update Posted: March 23, 2012
Last Verified: March 2012

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