NCT03025503

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 19, 2017

Status Verified

December 1, 2016

Enrollment Period

1 year

First QC Date

December 18, 2016

Last Update Submit

January 16, 2017

Conditions

Delivery Delayed

Outcome Measures

Primary Outcomes (1)

  • progression to active labor as measured by the Bishop score

    6 hours

Study Arms (2)

nipple stimulation

EXPERIMENTAL
Other: nipple stimulation

no intervention

NO INTERVENTION

Interventions

nipple stimulationOTHER
nipple stimulation

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, Israel

Location

Central Study Contacts

Drorith Hochner-Celnikier, MD

CONTACT

00 972 2 5844400hochner@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2016

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

January 19, 2017

Record last verified: 2016-12

Locations

IL(1)