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NCT00815542 Clinical Trial

Induction of Labor in Oligohydramnios

Cervical Ripening Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00815542
Other study ID # 034-2011-MMC
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received December 25, 2008
Last updated March 22, 2012
Start date June 2012
Est. completion date June 2012

Study information
Verified date March 2012
Source Meir Medical Center
Contact Tal Biron - Shental, MD
Phone 972-577-482716
Email Biront@clalit.org.il
Is FDA regulated No
Health authority Israel: Clalit Health Services
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

Device:
• double balloon catheter
cervical ripening using double balloon catheter
Drug:
• prostaglandins E2
prostaglandins E2 - Intravaginal Propess for 24 hours

Locations
Country Name City State
Israel Meir Medial Center Kfar Saba

Sponsors (1)
Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary patients satisfaction induction of labor, delivery and early postpartum No
See also
  Status Clinical Trial Phase
Recruiting NCT04949633 - Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening Phase 3
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
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
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A