Exploration and Determination of Genomic Markers Predictive of Uterine Atony

• Conditions: Uterine Atony

• Registration Number: NCT03413917
• Lead Sponsor: Baylor Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-01-29
• Study Start: 2018-02-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-17
• Primary Completion: 2018-12-01
• Study Completion: 2019-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of genomic markers that can predict uterine atony	6-12 months	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.
Identification of genomic markers that can predict uterine atony (3)	6-12 months	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.
Identification of genomic markers that can predict uterine atony (2)	6-12 months	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.

Trial Locations

Locations (1)

Baylor Univeristy Medical Center; 🇺🇸 Dallas, Texas, United States