Nipple Stimulation for Labor Induction

NCT ID: NCT03025503

Last Updated: 2017-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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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

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Conditions

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Delivery Delayed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nipple stimulation

Group Type EXPERIMENTAL

nipple stimulation

Intervention Type OTHER

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nipple stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Drorith Hochner-Celnikier, MD

Role: CONTACT

00 972 2 5844400

Other Identifiers

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NippleStim-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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