Nipple Stimulation for Labor Induction | NCT03025503

Studies
Nipple Stimulation for Labor Induction

NCT03025503

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jan 19, 2017Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Delivery Delayed

Interventions

nipple stimulation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Jan 2018Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Dec 18, 2016

First Submission Date that Met QC Criteria

Jan 16, 2017

First Posted Date

Jan 19, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 19, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
nipple stimulation	Experimental		Other: nipple stimulation
no intervention	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nipple stimulation	Other		nipple stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression to active labor as measured by the Bishop score		6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Drorith Hochner-Celnikier, MD	Contact	00 972 2 5844400		hochner@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided