Exploration and Determination of Genomic Markers Predictive of Uterine Atony

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uterine Atony Dystocia Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases Uterine Inertia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Baylor Univeristy Medical Center

Dallas, Texas, 75246, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Analysis of genomic markers in uterine atony

Other

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

Primary outcomes

Identification of genomic markers that can predict uterine atony

Time frame: 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 (2)

Time frame: 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.
Identification of genomic markers that can predict uterine atony (3)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Jan 29, 2018
Registry last updated: Jan 26, 2026

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.

Published trials that share one or more normalized conditions with this study.

Completed