Postpartum HemorrhageNCT00989027
Impact of Uterotonic Agents on Isolated Human Myometrium
A study testing Oxytocin, Ergonovine and Carboprost in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. 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, Ergonovine and Carboprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2007to Aug 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 37-41 weeks
- Non-laboring patients, not exposed to exogenous oxytocin
- Patients requiring primary Cesarean section
- Cesarean section under spinal anesthesia
Who cannot join
- Patients who require general anesthesia
- Patient who had previous uterine surgery or Cesarean section
- Patients with placental anomalies
- Emergency Cesarean section in labor
- Patients with bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.
The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.
Read the detailed description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).
Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin, Ergonovine, Carboprost, Oxytocin and Ergonovine, Oxytocin and Carboprost
- Keywords
- Uterine contraction, Dose-response, Oxytocin pre-treatment
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Oxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
ErgonovineDrug
Also called Ergonovine Maleate
Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
CarboprostDrug
Also called Hemabate
Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and ErgonovineDrug
Also called Oxytocin, Ergonovine
Oxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
Oxytocin and CarboprostDrug
Also called Oxytocin, Hemabate
Oxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs. |
| Treatment | Active comparator | Samples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured. Receives: Drug: Oxytocin; Drug: Ergonovine; Drug: Carboprost; Drug: Oxytocin and Ergonovine; Drug: Oxytocin and Carboprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of contraction
Measured: 6-8 hours
Secondary outcomes (3)
Integrated area under response curve (AUC)
Measured: 6-8 hours
Basal tone
Measured: 6-8 hours
Frequency of contraction
Measured: 6-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionAug 2013
- Study completionAug 2013
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989027
- Sponsor's protocol ID
- 07-08
- Status last verified
- Feb 2014
- First submitted
- 29 Jul 2009
- Last updated
- 20 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Uterotonic Agents on Isolated Human Myometrium
- ClinicalTrials.gov ID
- NCT00989027
- Acronym / sponsor ID
- 07-08
- Conditions
- Postpartum Hemorrhage
- Keywords
- Uterine contraction, Dose-response, Oxytocin pre-treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 2 Oct 2009 (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.
The purpose of this study is to compare the ability of a sample of uterine muscle tissue to contract in the presence of various drugs. The drugs studied are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst the uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost, the most effective one to use is not known.
The investigators will be testing uterine muscle samples in the presence of these drugs at various concentrations, to see what their contractility measures over time, as compared with a control sample, in which no drugs will be applied.
Detailed description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality and morbidity. In 80% cases of PPH, the primary cause is failure of the uterus to contract after delivery of the baby, which then requires further treatment of the mother with uterotonic drugs (drugs used to contract uterus and thus prevent bleeding).
Patients participating in this study will be asked to donate a very small sample of uterine tissue during Cesarean section, which will be tested for the ability to contract after treatment with various uterotonic drugs (oxytocin, ergonovine and carboprost) in the laboratory. This information will help us know the effect of these drugs by comparing the contractile capability of the uterine tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –A control sample from each patient (no uterotonic drug applied) will be measured concurrently with samples treated with various drugs. |
| Treatment | Active comparator | Drug: Oxytocin, Drug: Ergonovine, Drug: Carboprost, Drug: Oxytocin and Ergonovine, Drug: Oxytocin and CarboprostSamples from each patient will be bathed in solutions containing varying concentrations of either oxytocin, carboprost and ergonovine, and contractility will be measured. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age 37-41 weeks
- Non-laboring patients, not exposed to exogenous oxytocin
- Patients requiring primary Cesarean section
- Cesarean section under spinal anesthesia
Key exclusion criteria (5 listed)
- Patients who require general anesthesia
- Patient who had previous uterine surgery or Cesarean section
- Patients with placental anomalies
- Emergency Cesarean section in labor
- Patients with bleeding disorders
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 |
|---|---|---|
| OxytocinOxytocin, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution. | Drug | Treatment |
| ErgonovineAlso: Ergonovine MaleateErgonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution. | Drug | Treatment |
| CarboprostAlso: HemabateCarboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution. | Drug | Treatment |
| Oxytocin and ErgonovineAlso: Oxytocin, ErgonovineOxytocin and Ergonovine, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution. | Drug | Treatment |
| Oxytocin and CarboprostAlso: Oxytocin, HemabateOxytocin and Carboprost, 10-9mol/L to 10-3mol/L, in Krebs-Henseleit solution. | Drug | Treatment |
Primary outcome
Amplitude of contraction
Time frame: 6-8 hours
3 secondary outcomes
Integrated area under response curve (AUC)
Time frame: 6-8 hours
Basal tone
Time frame: 6-8 hours
Frequency of contraction
Time frame: 6-8 hours
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 20 Feb 2014.
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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.
Mrinalini Balki, MD principal investigator
MOUNT SINAI HOSPITAL
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, Ergonovine and Carboprost in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital 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 4 inclusion and 5 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 20 Feb 2014. 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. 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?
Amplitude of contraction (time frame: 6-8 hours). 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 20 Feb 2014.