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IV vs IM Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

G

Gynuity Health Projects

Status

Completed

Conditions

Postpartum Hemorrhage

Treatments

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.

Full description

The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

Enrollment

653 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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: Women who are:

  • Planned or transferred for delivery via Cesarean section
  • Not delivering a live birth
  • Unable to provide informed consent due to mental impairment, distress during labor or other reason
  • Unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

653 participants in 2 patient groups

IV infusion
Active Comparator group
Description:
Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby.
Treatment:
Drug: Oxytocin
Drug: Oxytocin
IM Injection
Active Comparator group
Description:
Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby.
Treatment:
Drug: Oxytocin
Drug: Oxytocin

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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