Oxytocin Receptor Expression in Pregnancy

Post-Abortion Clinical Trial

Official title:

Oxytocin Receptor Expression in Pregnancy: When Does it Turn on

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03907735
• Other study ID #: OHSU IRB 19417
• Status: Active, not recruiting
• Start date: June 3, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: August 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Hemorrhage, Obstetric
• Post-Abortion

Intervention

Other:
• Myometrial tissue sample collection
Myometrial tissue samples by core needle biopsy under ultrasound guidance

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Function of myometrial oxytocin receptor	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).	30 minutes