Oxytocin Receptor Expression in Pregnancy

NCT ID: NCT03907735

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2025-08-31

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.

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.

Conditions

Post-Abortion; Hemorrhage, Obstetric

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Myometrial tissue sample collection

Intervention Type: OTHER

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.

Myometrial tissue sample collection

Intervention Type: OTHER

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).

Myometrial tissue sample collection

Intervention Type: OTHER

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.

Myometrial tissue sample collection

Intervention Type: OTHER

Myometrial tissue samples by core needle biopsy under ultrasound guidance

Interventions

Myometrial tissue sample collection

Myometrial tissue samples by core needle biopsy under ultrasound guidance

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jessica Reid

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Reid, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU IRB 19417

Identifier Type: -

Identifier Source: org_study_id