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Oxytocin Receptor Expression in Pregnancy

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Active, not recruiting

Conditions

Post-Abortion
Hemorrhage, Obstetric

Treatments

Other: Myometrial tissue sample collection

Study type

Observational

Funder types

Other

Identifiers

NCT03907735
OHSU IRB 19417

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 4 patient groups

2nd trimester
Description:
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.
Treatment:
Other: Myometrial tissue sample collection
Non-pregnant
Description:
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.
Treatment:
Other: Myometrial tissue sample collection
1st trimester
Description:
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).
Treatment:
Other: Myometrial tissue sample collection
After term pregnancy (3rd trimester)
Description:
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.
Treatment:
Other: Myometrial tissue sample collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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