Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nipple Stimulation for Labor Induction

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.
 
ClinicalTrials.gov Identifier: NCT03025503
Recruitment Status : Unknown
Verified December 2016 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will examine the use of nipple stimulation for cervical ripening in women who present to the labor and delivery ward after their water has broken but have a contraindication to prostaglandins.

Condition or disease Intervention/treatment Phase
Delivery Delayed Other: nipple stimulation Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: nipple stimulation Other: nipple stimulation
No Intervention: no intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. progression to active labor as measured by the Bishop score [ Time Frame: 6 hours ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Week 37 + 0 and on
  • PROM (premature rupture of membranes)
  • Multiparity (birth sixth or higher) or TOLAC (trial of labor after Caesarean section)
  • Not in active labor - without regular contractions fetal monitor, cervical dilation < 4 cm and effacement < 80%.

Exclusion Criteria:

  • Water break > 24 hours at the time of admission to the delivery room
  • Active vaginal bleeding with suspected placental abruption
  • Maternal fever
  • Multifetal pregnancy
  • Women with contraindication for vaginal birth
  • Preeclampsia
  • IUGR (intrauterine growth restriction)
  • Macrosomia
  • Non-reassuring fetal heart tracing
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03025503


Contacts
Layout table for location contacts
Contact: Drorith Hochner-Celnikier, MD 00 972 2 5844400 hochner@hadassah.org.il

Locations
Layout table for location information
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT03025503    
Other Study ID Numbers: NippleStim-HMO-CTIL
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided