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Breast Stimulation Versus Pitocin for Induction of Labor

H

Hadassah Medical Center

Status

Unknown

Conditions

Labor Induction

Treatments

Procedure: breast pump nipple stimulation
Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT00984347
280808-HMO-CTIL

Details and patient eligibility

About

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

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Oxytocin induction
Active Comparator group
Description:
women in need for induction of labor due to medical indications, will receive continuous IV oxytocin
Treatment:
Drug: Oxytocin
Breast Stimultion
Active Comparator group
Description:
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.
Treatment:
Procedure: breast pump nipple stimulation

Trial contacts and locations

1

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Central trial contact

Yael Sciaky-Tamir, MD; Drorith Hochner-Celnikier, MD

Data sourced from clinicaltrials.gov

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