Oxytocin Via Intramuscular Injection and Intravenous Bolus or Infusion for Prevention of Postpartum Hemorrhage

Gynuity Health Projects

Status: Completed

Conditions: Postpartum Hemorrhage

Treatments: Drug: Oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01914419

3000a

Details and patient eligibility

About

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via intravenous (IV) infusion or IV bolus reduces the rate of postpartum hemorrhage compared to intramuscular (IM) injection.

Full description

The study will compare the effect of IV infusion or IV bolus to IM oxytocin administration with respect to mean blood loss and the proportion of women who experience blood loss greater than or equal to 500 ml, women who experience blood loss greater than or equal to 350 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery.

Enrollment: 4,983 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All women who present in active labor for a live birth at the study hospital will be considered for participation in the study

Exclusion criteria

• Planned or transferred for delivery via Cesarean section
• Administration of a pre-delivery uterotonic to induce or augment labor
• Unable to provide informed consent due to mental impairment, distress during labor or other reason

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,983 participants in 3 patient groups

IV infusion

Active Comparator group

Description:

Oxytocin 10 IU will be administered by IV infusion according to randomization assignment as soon as possible after delivery of the baby.

Treatment:

Drug: Oxytocin

IV bolus

Active Comparator group

Description:

Oxytocin 10 IU will be administered by IV bolus according to randomization assignment as soon as possible after delivery of the baby.

Treatment:

Drug: Oxytocin

IM injection

Active Comparator group

Description:

Oxytocin 10 IU will be administered by IM injection according to randomization assignment as soon as possible after delivery of the baby.

Treatment:

Drug: Oxytocin