Postpartum HemorrhageNCT01108302
Effectiveness, Safety and Feasibility of Auxiliary Nurse Midwives' (ANM) Use of Oxytocin in Uniject™ to Prevent Postpartum Hemorrhage in India
A study testing Oxytocin in Uniject in people with Postpartum Hemorrhage, run by Johns Hopkins Bloomberg School of Public Health at 1 site in India.
Trial summary
This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce… Read more about this study
- Who is it for?
- Any age, 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
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2011to Jun 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- gestational age >=28 wks at enrollment
- anticipate spontaneous vaginal delivery
- hemoglobin >=8 gm/dl
- delivery at home, sub-center, or primary health center
- delivery attended by Auxilliary Nurse Midwife
Who cannot join
- previous caesarean-section
- scheduled for caesarean-section
- antepartum bleeding during current pregnancy
- blood pressure >140mm of Hg systolic and >90mm of Hg diastolic
- in active labor at time of recruitment
- high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery
Trial locations and contacts
1 site in 1 country.
India1 site
Jawaharlal Nehru Medical College Women's and Children's Health Research Unit
Belagavi, Karnataka
About this study
Official title: Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India
This cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin in Uniject
- Keywords
- uterotonic, oxytocin, randomized trial, India, community, hemorrhage
- 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 Pitocin, Syntocinon
10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
| Study group | Role | What they receive |
|---|---|---|
| PPH Treatment only | No intervention | Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject |
| Oxytocin in Uniject | Experimental | Auxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery Receives: Other: Oxytocin in Uniject |
What is being measured
The primary outcome is the main question the study is designed to answer.
postpartum hemorrhage
blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
Measured: after delivery of 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 and before birth of the baby
Measured: pregnancy
neonatal death
neonatal death is defined as death of a live born infant 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 startSep 2011
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: PATH withdrew IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, PATH, Bill and Melinda Gates Foundation
- Investigators
- Cynthia Stanton, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthShivaprasad Goudar, MD, Principal investigator, JN Medical College, Belgaum, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108302
- Sponsor's protocol ID
- GAT.1429-07882-2
- Status last verified
- Dec 2011
- First submitted
- 2 Apr 2010
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness, Safety and Feasibility of Expanding Use of Oxytocin in Uniject™ by Auxiliary Nurse Midwives to Prevent Postpartum Hemorrhage: A Community-based Cluster Randomized Trial in Bagalkot, India
- ClinicalTrials.gov ID
- NCT01108302
- Acronym / sponsor ID
- GAT.1429-07882-2
- Conditions
- Postpartum Hemorrhage
- Keywords
- uterotonic, oxytocin, randomized trial, India, community, hemorrhage
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PATH withdrew IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, PATH, Bill and Melinda Gates Foundation
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- 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 cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 IU of oxytocin in Uniject™ during the third stage of labor by an Auxiliary Nurse Midwife (ANM) at births occurring in homes, Sub-Centers and Primary Health Centers in Bagalkot, India will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. The study will also document correct use of oxytocin in Uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPH Treatment only | No intervention | –Auxilliary nurse midwives will be able to treat for PPH only, not provide Oxytocin in Uniject |
| Oxytocin in Uniject | Experimental | Other: Oxytocin in UnijectAuxilliary Nurse Midwives will provide 10IU Oxytocin in Uniject device IM immediately after delivery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- gestational age >=28 wks at enrollment
- anticipate spontaneous vaginal delivery
- hemoglobin >=8 gm/dl
- delivery at home, sub-center, or primary health center
- delivery attended by Auxilliary Nurse Midwife
Key exclusion criteria (6 listed)
- previous caesarean-section
- scheduled for caesarean-section
- antepartum bleeding during current pregnancy
- blood pressure >140mm of Hg systolic and >90mm of Hg diastolic
- in active labor at time of recruitment
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: Pitocin, Syntocinon10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby | Other | Oxytocin in Uniject |
Primary outcome
postpartum hemorrhage
Time frame: after delivery of baby
blood loss >=500 ml after delivery of the baby, as measured through a plastic calibrated drape.
4 secondary outcomes
Oxytocin use before delivery
Time frame: labor and delivery
stillbirth
Time frame: pregnancy
neonatal death
Time frame: first month of life
need for neonatal resuscitation
Time frame: 0-6 hours after birth
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
Related trials for Postpartum Hemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
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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
Shivaprasad Goudar, MD principal investigator
JN Medical College, Belgaum, India
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 India.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Jan 2012. 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 India. 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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: after delivery of baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2012.