Induction of Labor in Oligohydramnios

Induction of Labor in Oligohydramnios - A Comparison Between Two Modes of Cervical Ripening for Patients With Oligohydramnios at Term

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Ripening
• Intervention / Treatment: Device: double balloon catheter; Drug: prostaglandins E2

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Tal Biron - Shental, MD; Phone Number: 972-577-482716; Email: Biront@clalit.org.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Medial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time from ripening to active labor and to delivery, rates of cesarean section, rates of nonreassuring fetal heart rate during induction of labor.	during induction of labor, delivery and early post partum

Secondary Outcome Measures

Outcome Measure	Time Frame
patients satisfaction	induction of labor, delivery and early postpartum

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Investigators: Principal Investigator: Tal Biron - Shental, MD, Meir Medical Center, Kfar Saba, Israel, Affiliated to Tel Aviv University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: December 25, 2008
• First Submitted That Met QC Criteria: December 28, 2008
• First Posted (Estimate): December 30, 2008

Study Record Updates

• Last Update Posted (Estimate): March 23, 2012
• Last Update Submitted That Met QC Criteria: March 22, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Oligohydramnios; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Dinoprostone
• Other Study ID Numbers: 034-2011-MMC