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Completed

NCT Number: NCT01914419

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

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.

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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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shatby Maternity Hospital, Alexandria University, Alexandria, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Oxytocin

Drug

Primary outcomes

  1. Proportion of women with postpartum blood loss equal to or greater than 500 mL

    Time frame: 1 hour after delivery of baby

    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

Secondary outcomes

  1. Mean postpartum blood loss

    Time frame: 1 hour after delivery of the baby

    Mean blood loss as measured in a plastic, calibrated container.

  2. Proportion of women with postpartum blood loss equal to or greater than 350 mL

    Time frame: 1 hour after delivery of the baby

    Postpartum blood loss equal to or greater than 500 mL as measured in a plastic, calibrated container.

  3. Proportion of women with postpartum blood loss equal to or greater than 1000 mL

    Time frame: 1 hour after delivery

    Postpartum blood loss equal to or greater than 1000 mL as measured in a plastic, calibrated container.

  4. Mean change in hemoglobin pre-delivery to postpartum

    Time frame: 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.

  5. Time to delivery of placenta

    Time frame: Within 1 hour of delivery of the baby

    Time interval in minutes between delivery of the baby and delivery of the placenta

  6. Administration of additional oxytocin, other uterotonics or other interventions such as blood transfusion or hysterectomy

    Time frame: Within 1 hour of delivery of the baby

  7. Side effects 1 hour postpartum

    Time frame: 1 hour after delivery of the baby

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • El Galaa Teaching Hospital
  • University of Alexandria

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2013
Registry last updated
Mar 11, 2016

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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