Breast Stimulation Versus Pitocin for Induction of Labor

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)

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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