NCT00984347

Brief Summary

The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.

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
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

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

September 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 25, 2009

Status Verified

September 1, 2009

Enrollment Period

11 months

First QC Date

September 23, 2009

Last Update Submit

September 24, 2009

Conditions

Labor Induction

Keywords

nipple stimulationOxytocininduction of laborterm pregnanciesgrandmultiparaVBACPROMcomparison of two methods for induction of labor

Outcome Measures

Primary Outcomes (1)

  • time from induction to delivery

    24h

Secondary Outcomes (2)

  • fetal distress (monitor assessment, cord ph)

    24 h

  • cesarean section rate

    24h

Study Arms (2)

Oxytocin induction

ACTIVE COMPARATOR

women in need for induction of labor due to medical indications, will receive continuous IV oxytocin

Drug: Oxytocin

Breast Stimultion

ACTIVE COMPARATOR

nipple stimulation with a breast pump, calibrated at the lowest suction strength,operated alternately: 15 min one breast, 15 min second breast, 15 min rest, till appearance of regular uterine contractions (3 contractions in 10 min). the manipulation will continue for 3 hours of regular contractions.

Procedure: breast pump nipple stimulation

Interventions

OxytocinDRUG

For low risk group (women at deliveries 1-5): IV oxytocin 10IU/1000ml standard sol. starting at 2MU/MIN and augmenting 2MU every 20 min. For high risk group (grandmultiparas \[6th delivery and up\] or women with a previous cesarean section) IV oxytocin 5IU/1000ml standard sol. starting at 1MU/MIN augmenting 1MU every 20 MIN - in accordance with the department's protocol

Also known as: Oxytocin for injection 10u/ml Rotex Medica
Oxytocin induction
breast pump nipple stimulationPROCEDURE

breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest

Breast Stimultion

Eligibility Criteria

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

You may qualify if:

  • years and older
  • completed 37 weeks gestation
  • singleton pregnancy
  • reassuring fetal heart rate at admission monitor

You may not qualify if:

  • multiple pregnancies
  • known fetal malformations
  • non reassuring NST
  • polyhydramnios (AFI\>220)
  • oligohydramnios
  • PET
  • IUGR
  • macrosomia (EFW \>4000g)
  • antepartum bleeding
  • maternal fever

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital Mt. Scopus

Jerusalem, Israel

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Drorith Hochner-Celnikeir, MD

    Hadasah Medical Organization

    STUDY CHAIR

Central Study Contacts

Yael Sciaky-Tamir, MD

CONTACT

+972-2-5844111yaels@hadassah.org.il

Drorith Hochner-Celnikier, MD

CONTACT

+972-2-8544410Hochner@hadassah.org.il

Study Design

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

Study Record Dates

First Submitted

September 23, 2009

First Posted

September 25, 2009

Study Start

November 1, 2009

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

September 25, 2009

Record last verified: 2009-09

Locations

IL(1)