In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity
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|ClinicalTrials.gov Identifier: NCT01865669|
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : February 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Oxytocin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 13, 2017|
|Actual Study Completion Date :||June 13, 2017|
No Intervention: Control
A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.
Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.
Oxytocin, 10-10mol/L to 10-5mol/L
Other Name: pitocin
- Motility index [ Time Frame: 6-8 hours ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865669
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Mrinalini Balki, MD||MOUNT SINAI HOSPITAL|