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Active, Not Recruiting

NCT Number: NCT03907735

Oxytocin Receptor Expression in Pregnancy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post-abortion Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Hemorrhage, Obstetric Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Health & Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myometrial tissue sample collection

Other

Myometrial tissue samples by core needle biopsy under ultrasound guidance

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Oxytocin Receptor Expression in Pregnancy: When Does it Turn on

Important dates

Study start
2019
Primary completion
2020
Study completion
2025
First posted
Apr 9, 2019
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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