Postpartum HemorrhagePhase 4NCT01252342
Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
A Phase 4 study testing Oxytocin and Saline in people with Postpartum Hemorrhage and Uterine Atony, run by University of Saskatchewan at 1 site in Canada.
Trial summary
Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Uterine Atony
- What is being tested?
- Oxytocin and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Apr 2012
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Parturients
- Elective cesarean Delivery
- Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
- Singleton fetus
- Vertex presentation
- Age > 18
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- BMI < 40
- Height > 5'2" and < 5"8"
- Written informed consent
Who cannot join
- Placenta previa
- Multiple gestation
- Preeclampsia
- Gestational Diabetes or pre-existing diabetes
- Macrosomia (estimated fetal weight prior to delivery)
- Polyhydramnios
Show all 11Show fewer
- Oligohydramnios
- Uterine fibroids
- More than 2 previous cesarean deliveries
- Suspected adherent placenta (acreta/increta/percreta)
- Planned general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.
It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).
Read more
The primary objectives of the study include:
- Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
- Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
- Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.
The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Being tested
- Oxytocin, Saline
- Keywords
- Oxytocin, Intramyometrial
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.
SalineDrug
10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.
| Study group | Role | What they receive |
|---|---|---|
| Intramyometrial oxytocin | Experimental | Not described Receives: Drug: Oxytocin |
| Intramyometrial Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Tone
Measured: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
Secondary outcomes (4)
Estimated Blood Loss
Measured: Immediately Post-operatively
Pre-operative to post-operative change in hematocrit
Measured: 24 hrs post-operative
Need for additional unterotonics
Measured: Immediately post delivery
Need for blood pressure support
Measured: Intra-operative period following administration of oxytocin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startAug 2011
- Primary completionApr 2012 (estimated)
- Study completionApr 2012 (estimated)
Why it stopped: Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.
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.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica K San Vicente, MD, Study director, University of Saskatchewan, Department of AnesthesiaDavid C Campbell, MD, FRCPC, Principal investigator, University of Saskatchewan, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252342
- Sponsor's protocol ID
- Oxytocin
- Status last verified
- Oct 2011
- First submitted
- 30 Nov 2010
- Last updated
- 11 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intramyometrial Oxytocin Improve Outcome in Elective Cesarean Delivery?
- ClinicalTrials.gov ID
- NCT01252342
- Acronym / sponsor ID
- Oxytocin
- Conditions
- Postpartum Hemorrhage, Uterine Atony
- Keywords
- Oxytocin, Intramyometrial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Proposed doses were too large, bolus oxytocin may cause cases of arrythmias, and some even advocate slowing down the infusion rates that are currently used.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 2 Dec 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.
Oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. However, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. Most dosage and delivery systems have been empirically derived.
It is currently our practice at the Royal University Hospital to start an oxytocin infusion (20U/L) once the baby has been delivered. Some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. A few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial).
The primary objectives of the study include:
- Determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin;
- Determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and
- Act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction.
The working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramyometrial oxytocin | Experimental | Drug: Oxytocin |
| Intramyometrial Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy Parturients
- Elective cesarean Delivery
- Term (> 37 wks gestational age) as defined by ultrasound or last menstrual period
- Singleton fetus
- Vertex presentation
Key exclusion criteria (11 listed)
- Placenta previa
- Multiple gestation
- Preeclampsia
- Gestational Diabetes or pre-existing diabetes
- Macrosomia (estimated fetal weight prior to delivery)
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 |
|---|---|---|
| Oxytocin10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr. | Drug | Intramyometrial oxytocin |
| Saline10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr. | Drug | Intramyometrial Saline |
Primary outcome
Uterine Tone
Time frame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals
4 secondary outcomes
Estimated Blood Loss
Time frame: Immediately Post-operatively
Pre-operative to post-operative change in hematocrit
Time frame: 24 hrs post-operative
Need for additional unterotonics
Time frame: Immediately post delivery
Need for blood pressure support
Time frame: Intra-operative period following administration of oxytocin
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 11 Jan 2012.
Related trials for Postpartum Hemorrhage
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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.
Monica K San Vicente, MD study director
University of Saskatchewan, Department of Anesthesia
David C Campbell, MD, FRCPC principal investigator
University of Saskatchewan, Department of Anesthesia
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 testing Oxytocin and Saline in people with Postpartum Hemorrhage and Uterine Atony, run by University of Saskatchewan at 1 site in Canada.
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 9 inclusion and 11 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 11 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 Canada. 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. Some participants in this study may receive a placebo. 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 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?
Uterine Tone (time frame: The blinded obstetrician will assess uterine tone at 1,2,4,6, 8 and 10-minute intervals). 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 11 Jan 2012.