Postpartum HemorrhageNCT01689311
In Vitro Myometrial Contractions in Laboring and Non-laboring Women
A study testing Oxytocin, Ergonovine and Prostaglandin F2alpha 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 an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--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 Prostaglandin F2alpha
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to Aug 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Gestational age 37-41 weeks
- Patients requiring primary or first repeat Cesarean section
- Cesarean section under spinal anesthesia
Who cannot join
- Patients who require general anesthesia
- Patient who had previous myometrial surgery or more than one previous Cesarean section
- Patients with placental anomalies
- Patients with multiple pregnancy (twins, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents
The purpose of this study is to compare the ability of an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.
The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.
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 in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin, Ergonovine, Prostaglandin F2alpha, Misoprostol
- Keywords
- Uterine contraction, Dose response, Non-laboring, Laboring, Laboring with oxytocin augmentation, Oxytocin, Ergonovine, Prostaglandin F2alpha, Misoprostol
- 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
Also called Pitocin
Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
ErgonovineDrug
Also called Ergot, Ergometrine
Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
Prostaglandin F2alphaDrug
Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
MisoprostolDrug
Also called Synthetic prostaglandin E1
Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol. Receives: Drug: Oxytocin; Drug: Ergonovine; Drug: Prostaglandin F2alpha; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of contraction
Measured: 4-5 hours
Secondary outcomes (3)
Integrated area under response curve (AUC)
Measured: 4-5 hours
Basal tone
Measured: 4-5 hours
Frequency of contraction
Measured: 4-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startMar 2009
- Primary completionAug 2011
- Study completionAug 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Canadian Anesthesiologists' Society
- Responsible party
- Sponsor
- Investigators
- Mrinalini Balki, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689311
- Sponsor's protocol ID
- 12-06
- Other IDs
- 09-0053-E
- Status last verified
- Sep 2012
- First submitted
- 17 Sep 2012
- Last updated
- 21 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Comparative efficacy of uterotonic agents: in vitro contractions in isolated myometrial strips of labouring and non-labouring women. Can J Anaesth. 2014 Sep;61(9):808-18. doi: 10.1007/s12630-014-0190-1. Epub 2014 Jun 7.
PubMed 24906304
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Myometrial Contractions in Laboring and Non-laboring Women: Oxytocin is Superior to Other Uterotonic Agents
- ClinicalTrials.gov ID
- NCT01689311
- Acronym / sponsor ID
- 12-06
- Conditions
- Postpartum Hemorrhage
- Keywords
- Uterine contraction, Dose response, Non-laboring, Laboring, Laboring with oxytocin augmentation, Oxytocin, Ergonovine, Prostaglandin F2alpha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Collaborators
- University of Toronto, Canadian Anesthesiologists' Society
- Study start
- Mar 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Sep 2012 (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 an isolated sample of uterine muscle tissue (in a tissue bath) to contract in the presence of various drugs. The drugs studied--uterotonics--are typically used to contract the uterus when a pregnant patient continues to bleed after delivery. Amongst common uterotonic drugs, namely oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol, the most effective one to use is unknown.
The investigators will be testing isolated uterine muscle samples to increasing concentrations of these four drugs in three patient populations: non-laboring, laboring without exogenous oxytocin augmentation, and laboring with oxytocin augmentation. Contractile measures will be measured and compared between all groups. The investigators hypothesize that oxytocin alone will have a weaker uterotonic effect in oxytocin-augmented laboring patients, and all four drugs will induce different patterns of contractions.
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 in the laboratory for the ability to contract in response to the uterotonics oxytocin, ergonovine, prostaglandin F2alpha, and misoprostol. We will seek to better understand the effects of these drugs by comparing their contractile capability in isolated uterine tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Oxytocin, Drug: Ergonovine, Drug: Prostaglandin F2alpha, Drug: MisoprostolAll samples will undergo dose response treatment (increasing concentrations) of one of the four uterotonic drugs: oxytocin, ergonovine, prostaglandin F2alpha, or misoprostol. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age 37-41 weeks
- Patients requiring primary or first repeat Cesarean section
- Cesarean section under spinal anesthesia
Key exclusion criteria (4 listed)
- Patients who require general anesthesia
- Patient who had previous myometrial surgery or more than one previous Cesarean section
- Patients with placental anomalies
- Patients with multiple pregnancy (twins, etc.)
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 |
|---|---|---|
| OxytocinAlso: PitocinOxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution. | Drug | Treatment |
| ErgonovineAlso: Ergot, ErgometrineErgonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution. | Drug | Treatment |
| Prostaglandin F2alphaProstaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution. | Drug | Treatment |
| MisoprostolAlso: Synthetic prostaglandin E1Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution. | Drug | Treatment |
Primary outcome
Amplitude of contraction
Time frame: 4-5 hours
3 secondary outcomes
Integrated area under response curve (AUC)
Time frame: 4-5 hours
Basal tone
Time frame: 4-5 hours
Frequency of contraction
Time frame: 4-5 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 21 Sep 2012.
- Derived from this study: PubMed 24906304Balki M, Erik-Soussi M, Kingdom J, Carvalho JC. Comparative efficacy of uterotonic agents: in vitro contractions in isolated myometrial strips of labouring and non-labouring women. Can J Anaesth. 2014 Sep;61(9):808-18. doi: 10.1007/s12630-014-0190-1. Epub 2014 Jun 7.
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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 Prostaglandin F2alpha 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 3 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 21 Sep 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. 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: 4-5 hours). 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 NCT01689311, 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 21 Sep 2012.