An observational study in Uterine Atony, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Baylor Research Institute · Observational
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.
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.
Patients recruited for the study will be pregnant women, 18 years of age or older who are laboring in Labor and Delivery, or who plan to have a scheduled cesarean section.
Exclusion Criteria:
patients who are admitted for repeat cesarean delivery with bilateral tubal ligation who do not develop uterine atony
Other: Analysis of genomic markers in uterine atony
Patients who develop uterine atony either during cesarean delivery or who require surgical management of atony after delivery
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.
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.
Time frame: 6-12 months
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.
Time frame: 6-12 months
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.
Time frame: 6-12 months
Plan to share: No
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baylor Research Institute