Skip to main content
OpenTrials
Completed

NCT Number: NCT01608958

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

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.

Completed

Looking for future studies?

Notify Me

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

Not applicable

Primary location

Hospital Gineco-Obstétrico Isidro Ayora, Quito, Ecuador

Loading trial locations.

About this study

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.

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

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.

Treatment and study plan

Oxytocin

Drug

10 IU oxytocin in 500 ml infusion

Primary outcomes

  1. Mean blood loss (ml)

    Time frame: minimum of 1 hour after delivery of baby

Secondary outcomes

  1. Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml

    Time frame: minimum of 1 hour after delivery of baby

  2. Change in hemoglobin from pre-delivery to postpartum

    Time frame: 12-24 hours after delivery

    Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge.

  3. Time to placental delivery

    Time frame: minimum of 1 hour after delivery of baby

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

    Time frame: minimum of 1 hour after delivery of baby

  5. Side effects 1 hour postpartum

    Time frame: 1 hour postpartum

  6. Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward

    Time frame: arrival to labor ward

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • Center for Research and Consultancy in Reproductive Health
  • Hung Vuong Hospital
  • MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital

Registry information

Official study title

Intravenous and Intramuscular Administration of Oxytocin in the Third Stage of Labor for Prevention of Postpartum Hemorrhage

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 31, 2012
Registry last updated
Mar 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.