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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
Sponsor:
Information provided by (Responsible Party):
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Oxytocin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Oxytocin

Arm Intervention/treatment
No Intervention: Control
A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.
Experimental: Oxytocin
Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.
Drug: Oxytocin
Oxytocin, 10-10mol/L to 10-5mol/L
Other Name: pitocin




Primary Outcome Measures :
  1. Motility index [ Time Frame: 6-8 hours ]

Secondary Outcome Measures :
  1. Amplitude of contraction [ Time Frame: 6-8 hours ]
  2. Integrated area under response curve (AUC) [ Time Frame: 6-8 hours ]
  3. Frequency of contraction [ Time Frame: 6-8 hours ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Investigators
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Principal Investigator: Mrinalini Balki, MD MOUNT SINAI HOSPITAL

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Responsible Party: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01865669     History of Changes
Other Study ID Numbers: 13-04
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Uterine contraction
Dose response
Oxytocin
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Obesity, Morbid
Hemorrhage
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs