Postpartum HemorrhageNCT01865669
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
A study testing Oxytocin in people with Postpartum Hemorrhage, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to 13 Jun 2017
- 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
- patients who give written informed consent
- patients requiring elective primary or 1st repeat Cesarean section
- patients with gestational age 37-41 weeks
- non-labouring patients, not exposed to exogenous oxytocin
- Cesarean section under spinal anesthetic
- patients <30 years of age with a normal pre-pregnancy BMI (20 and 24.9 kg/m2)
- patients ≥40 years of age with a normal pre-pregnancy BMI
- patients with a BMI≥40 kg/m2 and age <30 years
Who cannot join
- patients who refuse to give written informed consent
- patients who require general anesthesia
- patients who have had more than one previous uterine surgery/CS
- patients with placental abnormalities (abruption, accreta, percreta)
- patients with bleeding disorders
- presence of any other risk factors for PPH
Trial locations and contacts
1 site in 1 country.
About this study
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin.
The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.
Read the detailed description
In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients. The investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of PPH in these patient populations.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Oxytocin
- Keywords
- Uterine contraction, Dose response, 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.
OxytocinDrug
Also called pitocin
Oxytocin, 10-10mol/L to 10-5mol/L
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin. |
| Oxytocin | Experimental | Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motility index
Measured: 6-8 hours
Secondary outcomes (3)
Amplitude of contraction
Measured: 6-8 hours
Integrated area under response curve (AUC)
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 posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completion13 Jun 2017
- Study completion13 Jun 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT01865669
- Sponsor's protocol ID
- 13-04
- Status last verified
- Feb 2018
- First submitted
- 28 May 2013
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Luca AM, Carvalho JCA, Ramachandran N, Balki M. The effect of morbid obesity or advanced maternal age on oxytocin-induced myometrial contractions: an in vitro study. Can J Anaesth. 2020 Jul;67(7):836-846. doi: 10.1007/s12630-020-01615-6. Epub 2020 Mar 18.
PubMed 32189217
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
- ClinicalTrials.gov ID
- NCT01865669
- Acronym / sponsor ID
- 13-04
- Conditions
- Postpartum Hemorrhage
- Keywords
- Uterine contraction, Dose response, Oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 31 May 2013 (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.
Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin.
The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.
Detailed description
In view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. The investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. It is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of PPH in these patients. The investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of PPH in these patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin. |
| Oxytocin | Experimental | Drug: OxytocinSamples from each patient will be bathed in a solution containing varying concentrations of oxytocin. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- patients who give written informed consent
- patients requiring elective primary or 1st repeat Cesarean section
- patients with gestational age 37-41 weeks
- non-labouring patients, not exposed to exogenous oxytocin
- Cesarean section under spinal anesthetic
Key exclusion criteria (6 listed)
- patients who refuse to give written informed consent
- patients who require general anesthesia
- patients who have had more than one previous uterine surgery/CS
- patients with placental abnormalities (abruption, accreta, percreta)
- 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 |
|---|---|---|
| OxytocinAlso: pitocinOxytocin, 10-10mol/L to 10-5mol/L | Drug | Oxytocin |
Primary outcome
Motility index
Time frame: 6-8 hours
3 secondary outcomes
Amplitude of contraction
Time frame: 6-8 hours
Integrated area under response curve (AUC)
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 6 Feb 2018.
- Derived from this study: PubMed 32189217Luca AM, Carvalho JCA, Ramachandran N, Balki M. The effect of morbid obesity or advanced maternal age on oxytocin-induced myometrial contractions: an in vitro study. Can J Anaesth. 2020 Jul;67(7):836-846. doi: 10.1007/s12630-020-01615-6. Epub 2020 Mar 18.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
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
Post Partum Hemorrhage
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 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 8 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: finished, as of the sponsor's last update on 6 Feb 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 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?
Motility index (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?
On the ClinicalTrials.gov record for NCT01865669, 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 6 Feb 2018.