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

Administration of Oxytocin Via Intramuscular Injection and Intravenous Bolus or Intravenous Infusion in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01914419

Enrollment

4983

Registered

2013-08-02

Start date

2014-04-30

Completion date

2015-09-30

Last updated

2016-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage, Oxytocin, Prevention, Third stage of labor, Hemoglobin, Intravenous, Intramuscular, Bolus

Brief summary

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.

Detailed 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.

Interventions

DRUGOxytocin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of women with postpartum blood loss equal to or greater than 500 mL	1 hour after delivery of baby	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

Secondary

Measure	Time frame	Description
Proportion of women with postpartum blood loss equal to or greater than 350 mL	1 hour after delivery of the baby	Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.
Proportion of women with postpartum blood loss equal to or greater than 1000 mL	1 hour after delivery	Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.
Mean change in hemoglobin pre-delivery to postpartum	At least 12 hours after removal of IV and within 48 hours of delivery of the baby	Hemoglobin will be measured in g/dL using the Hemocue machine. Pre-delivery hemoglobin will be taken during labor.
Mean postpartum blood loss	1 hour after delivery of the baby	Mean blood loss as measured in a plastic, calibrated container.
Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy	Within 1 hour of delivery of the baby	—
Side effects 1 hour postpartum	1 hour after delivery of the baby	—
Time to delivery of placenta	Within 1 hour of delivery of the baby	Time interval in minutes between delivery of the baby and delivery of the placenta

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026