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IV Versus IM Administration of Oxytocin for Postpartum Bleeding

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ClinicalTrials.gov Identifier: NCT02954068
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Centro Rosarino de Estudios Perinatales (CREP)
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: IV Oxytocin + IM placebo Drug: IM Oxytocin + IV placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Active Comparator: IV Infusion
Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU
Drug: IV Oxytocin + IM placebo
Active Comparator: IM administration
Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml
Drug: IM Oxytocin + IV placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954068


Locations
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Argentina
Hospital J.R. Vidal
Corrientes, Argentina
Sponsors and Collaborators
Gynuity Health Projects
Centro Rosarino de Estudios Perinatales (CREP)
Investigators
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Principal Investigator: Beverly Winikoff, MD, MPH Gynuity Health Projects
Principal Investigator: Ilana Dzuba, MPH Gynuity Health Projects
Principal Investigator: Guillermo Carroli, MD Centro Rosarino de Estudios Perinatales (CREP)

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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT02954068     History of Changes
Other Study ID Numbers: 3008
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Keywords provided by Gynuity Health Projects:
Oxytocin

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs