Postpartum HemorrhageNCT01108289
Effect of Prophylactic Administration of Oxytocin in Uniject™ on Postpartum Hemorrhage at Home Births in Ghana
A study testing Oxytocin in Uniject in people with Postpartum Hemorrhage, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ghana.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Oxytocin in Uniject
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,586 participants
- Where
- 1 siteGhana
- Study dates
- Apr 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- home delivery
- presence of Community Health Officer at time of delivery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin in Uniject
- Keywords
- hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial
- Medical subject headings
- Postpartum Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin in UnijectOther
Also called uterotonic, pitocin
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin in Uniject | Experimental | Community Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby Receives: Other: Oxytocin in Uniject |
| PPH Treatment Only | No intervention | Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum hemorrhage-1
blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape
Measured: after delivery of baby
postpartum hemorrhage-2
blood loss >=500ml OR treatment dose of oxytocin provided
Measured: after delivery of the baby
postpartum hemorrhage-3
blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding
Measured: after delivery of the baby
Secondary outcomes (4)
Oxytocin use before delivery
the proportion of deliveries where oxytocin in uniject was administered prior to the delivery of the baby
Measured: labor and delivery
stillbirth
stillbirth is defined as death of a fetus after 28 weeks of gestation, prior to birth
Measured: labor/delivery
neonatal death
neonatal death is defined as death of a live born baby prior to completion of 28 days
Measured: first month of life
need for neonatal resuscitation
Measured: 0-6 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, PATH, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Cynthia Stanton, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthSam Newton, MD, PhD, Principal investigator, Kintampo Health Research Center, Kintampo, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108289
- Sponsor's protocol ID
- GAT.1429-07882-1
- Status last verified
- Jul 2013
- First submitted
- 2 Apr 2010
- Last updated
- 2 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1.
PubMed 24130463Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42.
PubMed 22676921
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01108289
- Acronym / sponsor ID
- GAT.1429-07882-1
- Conditions
- Postpartum Hemorrhage
- Keywords
- hemorrhage, uterotonic, oxytocin, blood loss, community, Ghana, randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,586 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Kintampo Health Research Centre, Ghana, PATH, Bill and Melinda Gates Foundation
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin in Uniject | Experimental | Other: Oxytocin in UnijectCommunity Health Officers will provide 10 IU Oxytocin in Uniject device IM immediately after delivery of baby |
| PPH Treatment Only | No intervention | –Community Health Officers will be able to treat for PPH only, not provide Oxytocin in Uniject |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- home delivery
- presence of Community Health Officer at time of delivery
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxytocin in UnijectAlso: uterotonic, pitocin10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby | Other | Oxytocin in Uniject |
Primary outcome
postpartum hemorrhage-1
Time frame: after delivery of baby
blood loss >=500 ml after delivery of the baby, as measured through plastic calibrated drape
postpartum hemorrhage-2
Time frame: after delivery of the baby
blood loss >=500ml OR treatment dose of oxytocin provided
postpartum hemorrhage-3
Time frame: after delivery of the baby
blood loss >=500ml OR treatment dose of oxytocin provided OR referral for bleeding
4 secondary outcomes
Oxytocin use before delivery
Time frame: labor and delivery
stillbirth
Time frame: labor/delivery
neonatal death
Time frame: first month of life
need for neonatal resuscitation
Time frame: 0-6 hours after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
- Derived from this study: PubMed 24130463Stanton CK, Newton S, Mullany LC, Cofie P, Tawiah Agyemang C, Adiibokah E, Amenga-Etego S, Darcy N, Khan S, Armbruster D, Gyapong J, Owusu-Agyei S. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU) by injection by community health officers in Ghana: a community-based, cluster-randomized trial. PLoS Med. 2013 Oct;10(10):e1001524. doi: 10.1371/journal.pmed.1001524. Epub 2013 Oct 1.
- Derived from this study: PubMed 22676921Stanton CK, Newton S, Mullany LC, Cofie P, Agyemang CT, Adiibokah E, Darcy N, Khan S, Levisay A, Gyapong J, Armbruster D, Owusu-Agyei S. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject by peripheral health care providers at home births: design of a community-based cluster-randomized trial. BMC Pregnancy Childbirth. 2012 Jun 7;12:42. doi: 10.1186/1471-2393-12-42.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Stanton, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Sam Newton, MD, PhD principal investigator
Kintampo Health Research Center, Kintampo, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin in Uniject in people with Postpartum Hemorrhage, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postpartum hemorrhage-1 (time frame: after delivery of baby). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.