Oxytocin Receptor Expression in Pregnancy

NCT03907735 | Active Not Recruiting

• 1 other identifier: OHSU IRB 19417
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Abortion; Hemorrhage, Obstetric

Keywords

Post-abortion hemorrhage; Obstetric hemorrhage; Preterm labor; Abnormal labor; Oxytocin; Oxytocin receptor

Outcome Measures

Primary Outcomes (1)

• 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).

  30 minutes

Secondary Outcomes (1)

• Function of myometrial oxytocin receptor

  30 minutes

Study Arms (4)

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

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

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

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

Interventions

Myometrial tissue sample collection OTHER

Myometrial tissue samples by core needle biopsy under ultrasound guidance

1st trimester; 2nd trimester; After term pregnancy (3rd trimester); Non-pregnant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Uterine biopsy tissue

MeSH Terms

Conditions

Hemorrhage; Obstetric Labor, Premature; Dystocia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jessica Reid, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 9, 2019
• Study Start: June 3, 2019
• Primary Completion: August 22, 2020
• Study Completion: August 1, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)