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Oxytocin Receptor Expression in Pregnancy

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ClinicalTrials.gov Identifier: NCT03907735
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jessica Reid, Oregon Health and Science University

Brief Summary:
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.

Condition or disease Intervention/treatment
Post-Abortion Hemorrhage, Obstetric Other: Myometrial tissue sample collection

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Oxytocin Receptor Expression in Pregnancy: When Does it Turn on
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Oxytocin

Group/Cohort Intervention/treatment
2nd trimester
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 by core needle biopsy under ultrasound guidance

Non-pregnant
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
Myometrial tissue samples by core needle biopsy under ultrasound guidance

1st trimester
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
Myometrial tissue samples by core needle biopsy under ultrasound guidance

After term pregnancy (3rd trimester)
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




Primary Outcome Measures :
  1. Oxytocin receptor expression [ Time Frame: 30 minutes ]
    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).


Secondary Outcome Measures :
  1. Function of myometrial oxytocin receptor [ Time Frame: 30 minutes ]
    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).


Biospecimen Retention:   Samples Without DNA
Blood Uterine biopsy tissue


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Women age 18-50
  • Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
  • Undergoing another planned surgical procedure with anesthesia (suction D&C, D&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
  • Able to give informed consent in English or Spanish

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:

  • Anemia (Hgb < 9)
  • Anticoagulation, bleeding disorder, or coagulopathy
  • Multiple gestation
  • Infection or sepsis

For ultrasound-guided procedures:

  • Obese, BMI ≥ 40
  • History of ≥2 cesarean sections
  • Large fibroids or uterine anomalies obstructing view
  • Other poor visualization
  • Thin myometrium < 1cm

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): NCT03907735


Contacts
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Contact: Women's Health Research Unit Confidential Recruitment Line 503-494-3666 whru@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit    503-494-3666    whru@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Jessica Reid, MD Oregon Health and Science University
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Responsible Party: Jessica Reid, Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03907735    
Other Study ID Numbers: OHSU IRB 19417
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jessica Reid, Oregon Health and Science University:
Post-abortion hemorrhage
Obstetric hemorrhage
Preterm labor
Abnormal labor
Oxytocin
Oxytocin receptor
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes