In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age… (NCT01865669) | Clinical Trial Compass
CompletedNot Applicable
In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
Canada44 participantsStarted 2013-05
Plain-language 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). 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motility index
Timeframe: 6-8 hours
Trial details
NCT IDNCT01865669
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital