Postpartum HemorrhagePhase 4NCT02954068
IV Versus IM Administration of Oxytocin for Postpartum Bleeding
A Phase 4 study of Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Argentina.
Trial summary
This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 543 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2016to 1 Oct 2017
- Phase
- Phase 4
- 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
- She is present to give birth to a live fetus
- Vaginal delivery
- Willing to participate in the study
- Able to give informed consent
Who cannot join
- Scheduled for a cesarean
- Reject the placement of an IV during labor (for intravenous infusion)
- Cannot give informed consent for any reason
- Not willing and / or cannot answer questions about background
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM
- Conditions
- Postpartum Hemorrhage
- Being tested
- IV Oxytocin + IM placebo, IM Oxytocin + IV placebo
- Keywords
- Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Oxytocin + IM placeboDrug
IM Oxytocin + IV placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| IV Infusion | Active comparator | Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU Receives: Drug: IV Oxytocin + IM placebo |
| IM administration | Active comparator | Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml Receives: Drug: IM Oxytocin + IV placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss (mL)
Measured: 1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml
Measured: 1 hour postpartum
Secondary outcomes (7)
Proportion of women who had postpartum blood loss ≥1000 ml
Measured: 1 hour postpartum
Average change in hemoglobin level
Measured: pre-delivery and at least 24 hours postpartum
Average time required until expulsion of the placenta
Measured: 1 hour postpartum
Proportion who needed additional Interventions
Measured: Through study completion, an average of 24-48 hours postpartum
Side effects
Measured: 1 hour postpartum
Blood pressure
Measured: 15, 30, 45 and 60 minutes postpartum
Heart rate
Measured: 15, 30, 45 and 60 minutes postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completion30 Sep 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Rosarino de Estudios Perinatales (CREP)
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsIlana Dzuba, MPH, Principal investigator, Gynuity Health ProjectsGuillermo Carroli, MD, Principal investigator, Centro Rosarino de Estudios Perinatales (CREP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954068
- Sponsor's protocol ID
- 3008
- Status last verified
- Apr 2018
- First submitted
- 28 Oct 2016
- Last updated
- 30 Apr 2018
- Results posted
- No
Publications
Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
PubMed 33169839
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Versus Intramuscular Administration of Oxytocin and Its Relationship With Postpartum Bleeding and Other Clinical Signs: a Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02954068
- Acronym / sponsor ID
- 3008
- Conditions
- Postpartum Hemorrhage
- Keywords
- Oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Centro Rosarino de Estudios Perinatales (CREP)
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 3 Nov 2016 (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 double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Infusion | Active comparator | Drug: IV Oxytocin + IM placeboOxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU |
| IM administration | Active comparator | Drug: IM Oxytocin + IV placeboOxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- She is present to give birth to a live fetus
- Vaginal delivery
- Willing to participate in the study
- Able to give informed consent
Key exclusion criteria (4 listed)
- Scheduled for a cesarean
- Reject the placement of an IV during labor (for intravenous infusion)
- Cannot give informed consent for any reason
- Not willing and / or cannot answer questions about background
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 |
|---|---|---|
| IV Oxytocin + IM placebo | Drug | IV Infusion |
| IM Oxytocin + IV placebo | Drug | IM administration |
Primary outcome
Amount of blood loss (mL)
Time frame: 1 hour postpartum
Proportion of women who had postpartum blood loss ≥500 ml
Time frame: 1 hour postpartum
7 secondary outcomes
Proportion of women who had postpartum blood loss ≥1000 ml
Time frame: 1 hour postpartum
Average change in hemoglobin level
Time frame: pre-delivery and at least 24 hours postpartum
Average time required until expulsion of the placenta
Time frame: 1 hour postpartum
Proportion who needed additional Interventions
Time frame: Through study completion, an average of 24-48 hours postpartum
Side effects
Time frame: 1 hour postpartum
Blood pressure
Time frame: 15, 30, 45 and 60 minutes postpartum
Heart rate
Time frame: 15, 30, 45 and 60 minutes postpartum
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 30 Apr 2018.
- Derived from this study: PubMed 33169839Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Ilana Dzuba, MPH principal investigator
Gynuity Health Projects
Guillermo Carroli, MD principal investigator
Centro Rosarino de Estudios Perinatales (CREP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Postpartum Hemorrhage, run by Gynuity Health Projects at 1 site in Argentina.
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 4 inclusion and 4 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 30 Apr 2018. 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 Argentina. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Amount of blood loss (mL) (time frame: 1 hour postpartum). The study lists 2 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 NCT02954068, which also lists 1 linked publication.
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 30 Apr 2018.