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Completed

NCT Number: NCT01108289

Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana

This study is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by a Community Health Officer (CHO) at home births in Ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.

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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

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kintampo Health Research Center

Kintampo, Brong Ahafo, Ghana

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • home delivery
  • presence of Community Health Officer at time of delivery

Exclusion criteria

  • None

Treatment and study plan

Oxytocin in Uniject

Other

10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby

Other names: uterotonic, pitocin

Primary outcomes

  1. postpartum hemorrhage-1

    Time frame: after delivery of baby

    blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape

  2. postpartum hemorrhage-2

    Time frame: after delivery of the baby

    blood loss >=500ml OR treatment dose of oxytocin provided

  3. postpartum hemorrhage-3

    Time frame: after delivery of the baby

    blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding

Secondary outcomes

  1. Oxytocin use before delivery

    Time frame: labor and delivery

    the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby

  2. stillbirth

    Time frame: labor/delivery

    stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth

  3. neonatal death

    Time frame: first month of life

    neonatal death is defined as death of a live born baby prior to completion of 28 days

  4. need for neonatal resuscitation

    Time frame: 0-6 hours after birth

Other outcomes

  1. Postpartum Hemorrhage >=1000ml

    Time frame: after delivery of the baby

    1000ml or more blood is observed in the collection drape

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Kintampo Health Research Centre, Ghana
  • PATH

Registry information

Official study title

The Oxytocin Initiative: Determining the Effect of Prophylactic Administration of Oxytocin in Uniject™ by a Community Health Officer on Postpartum Hemorrhage at Home Births in Four Districts in Ghana

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2010
Registry last updated
Jul 2, 2013

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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