An observational study in Post-Abortion and Hemorrhage, Obstetric, sponsored by Oregon Health and Science University. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Oregon Health and Science University · Observational
This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.
In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 893 observational studies indexed under Hemorrhage.
Browse Hemorrhage studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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This is a study of reproductive age women over 18 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for pre-operative appointments in our outpatient Center for Women's Health Family Planning Clinic and OHSU Labor and Delivery.
Exclusion Criteria:
To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.
Increased risk of hemorrhage:
For ultrasound-guided procedures:
Second trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained primarily after second trimester surgical abortions or Dilation and Evacuation (D\&E) procedures as well as after rare gravid hysterectomies or after late second trimester cesarean deliveries.
Other: Myometrial tissue sample collection
Myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in non-pregnant women undergoing gynecologic surgery under anesthesia for laparoscopic tubal ligation.
Other: Myometrial tissue sample collection
First trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained after first trimester surgical abortions or suction dilation and curettage (D\&C).
Other: Myometrial tissue sample collection
Third trimester myometrial tissue samples will be collected by core needle biopsy under ultrasound guidance in anesthetized women. Samples will be obtained at the time of cesarean delivery.
Other: Myometrial tissue sample collection
Myometrial tissue samples by core needle biopsy under ultrasound guidance
Oxytocin receptor expression
Measure of oxytocin receptor expression. Perform quantitative RT-PCR on mRNA extracted from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).
Time frame: 30 minutes
Function of myometrial oxytocin receptor
Assessment of the function of the myometrial oxytocin receptor. Measure intracellular calcium in cultured myometrial cells after activating the receptor with oxytocin from biopsy samples obtained from subjects at the end of their procedure (within 30 minutes).
Time frame: 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Oregon Health and Science University