Exploration and Determination of Genomic Markers Predictive of Uterine Atony

Uterine Atony Clinical Trial

Official title:

Exploration and Determination of Genomic Markers Predictive of Uterine Atony

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413917
• Other study ID #: 017-356
• Status: Recruiting
• Start date: February 2, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: July 2018
• Source: Baylor Research Institute
• Contact: Jack Stecher, MD
• Phone: 214-820-2126
• Email: jackstecher[@]sbcglobal.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to determine whether there are markers in the tissue of atonic uteri, and in the patients' plasma that would help identify patients likely to suffer postpartum hemorrhage due to uterine atony. We also will attempt to identify the cause(s) of uterine atony that might suggest mechanisms to prevent and manage it.

Description:

Patient will be recruited from those admitted to our Labor and Delivery unit. Ten women will be the control subjects, and these will be selected from patients who are admitted for scheduled cesarean delivery. Ten women will be selected from women who develop uterine atony either following cesarean delivery, or postpartum patients who delivered vaginally but subsequently required surgical management of uterine atony (hysterectomy or uterine saving surgery). From each patient a small amount of uterine muscle will be excised and placed in a fixative, preservative transport medium. Ten cubic centimeters of blood will be drawn from each patient to accompany the tissue. The tissue and blood will be processed and analyzed to identify differences in the tissue and plasma of messenger RNA, micro RNA, long non-coding RNA, and DNA methylation in normal and atonic uterine patients. Statistical analysis of these markers will be performed to determine whether there are significant differences in their expression. It is hoped that differences will be discovered that may be used diagnostically to predict uterine atony, and differences that may suggest the etiology of uterine atony.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 15, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• female

• pregnancy over 23 weeks gestation

Exclusion Criteria:

• under 18 years of age

• prisoners

• non-female sex

• cannot provide informed consent

Related Conditions & MeSH terms

• Uterine Atony
• Uterine Inertia

Intervention

Other:
• Analysis of genomic markers in uterine atony
No intervention will be performed. We will be analyzing tissue and blood samples only to identify potential association of genomic markers with uterine atony.

Locations

Country	Name	City	State
United States	Baylor Univeristy Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Toiyama Y, Okugawa Y, Tanaka K, Araki T, Uchida K, Hishida A, Uchino M, Ikeuchi H, Hirota S, Kusunoki M, Boland CR, Goel A. A Panel of Methylated MicroRNA Biomarkers for Identifying High-Risk Patients With Ulcerative Colitis-Associated Colorectal Cancer. Gastroenterology. 2017 Dec;153(6):1634-1646.e8. doi: 10.1053/j.gastro.2017.08.037. Epub 2017 Aug 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genomic markers that can predict uterine atony	To extract RNA from serum and uterine tissue samples and use Next Generation miRNA Sequencing followed by quantification of serum miRNA and miRNA isoform expression using TaqMan miRNA assays and NanoString.	6-12 months
Primary	Identification of genomic markers that can predict uterine atony (2)	Following extraction of miRNA, to use Optical Liquid Stamping technology to analyze various miRNA isoforms in the uterine tissue and serum of subjects with normal uteri compared to atonic uteri.	6-12 months
Primary	Identification of genomic markers that can predict uterine atony (3)	To isolate DNA using QIAAMp DNA mini kits from uterine tissue and serum samples from subjects with atonic uteri and normal uteri and to then sequence the DNA using HiSeq Genome Analyzer. We will identify the sequence reads using Illumina base-calling software and analyze them using Zymo research proprietary analysis pipeline to identify differences in genomic expression in subjects with normal uteri compared to atonic uteri.	6-12 months