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OpenTrials
Completed

NCT Number: NCT02954068

IV Versus IM Administration of Oxytocin for Postpartum Bleeding

This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM

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Key information

Conditions

Postpartum Hemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital J.R. Vidal

Corrientes, Argentina

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • She is present to give birth to a live fetus
  • Vaginal delivery
  • Willing to participate in the study
  • Able to give informed consent

Exclusion criteria

  • Scheduled for a cesarean
  • Reject the placement of an IV during labor (for intravenous infusion)
  • Cannot give informed consent for any reason
  • Not willing and / or cannot answer questions about background

Treatment and study plan

IV Oxytocin + IM placebo

Drug

IM Oxytocin + IV placebo

Drug

Primary outcomes

  1. Amount of blood loss (mL)

    Time frame: 1 hour postpartum

  2. Proportion of women who had postpartum blood loss ≥500 ml

    Time frame: 1 hour postpartum

Secondary outcomes

  1. Proportion of women who had postpartum blood loss ≥1000 ml

    Time frame: 1 hour postpartum

  2. Average change in hemoglobin level

    Time frame: pre-delivery and at least 24 hours postpartum

  3. Average time required until expulsion of the placenta

    Time frame: 1 hour postpartum

  4. Proportion who needed additional Interventions

    Time frame: Through study completion, an average of 24-48 hours postpartum

  5. Side effects

    Time frame: 1 hour postpartum

  6. Blood pressure

    Time frame: 15, 30, 45 and 60 minutes postpartum

  7. Heart rate

    Time frame: 15, 30, 45 and 60 minutes postpartum

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Centro Rosarino de Estudios Perinatales (CREP)

Registry information

Official study title

Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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