Nipple Stimulation for Labor Induction

Delivery Delayed Clinical Trial

Official title:

Nipple Stimulation for Labor Induction: Efficiency, Safety and Satisfaction Measures

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03025503
• Other study ID #: NippleStim-HMO-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: December 18, 2016
• Last updated: January 16, 2017
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: December 2016
• Source: Hadassah Medical Organization
• Contact: Drorith Hochner-Celnikier, MD
• Phone: 00 972 2 5844400
• Email: hochner[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery Delayed

Intervention

Other:
• nipple stimulation

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression to active labor as measured by the Bishop score		6 hours