ClinicalTrials.gg
CompletedNCT03413917Updated Jan 26, 2026

Exploration and Determination of Genomic Markers Predictive of Uterine Atony

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

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Study type
Observational
Model
Other
Time perspective
Other
Enrollment
21
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Uterine Inertia with a site in United States — 1 open to participants now, 1 under way, none of them phase 3. Uterine Inertia · United States.

Started
2018
the only one that year
Observational
Only one
of the 10
Registered
5th of 10
by date
Lead sponsor
2 of 10
Baylor Research Institute

Among the 10 studies in Uterine Inertia with a site in United States, this one is the only one that started in 2018, is the only observational one, and was the 5th registered.

Uterine Inertia

39 studies on the registry are indexed under Uterine Inertia; 7 are open to participants now.

Browse Uterine Inertia studies →

Open to participants now

1 of the 10 studies in Uterine Inertia with a site in United States is open now. Recruiting first, the newest first:

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 3 Uterine Inertia studies recruiting now, 2 set no upper age limit and 1 stops at 75 or younger; none take children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · female · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Uterine Atony

Browse trials for

Keywords

  • genomic markers
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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Inclusion criteria

  • 18 years of age or older
  • female
  • pregnancy over 23 weeks gestation

Exclusion criteria

Exclusion Criteria:

  • under 18 years of age
  • prisoners
  • non-female sex
  • cannot provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
21 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Control group

    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

  • Study group

    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

Interventions

  • OtherAnalysis 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Baylor Univeristy Medical Center
    Dallas, Texas 75246, United States
08

References and documents

Publications

  • 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. PubMed 28847750 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Jul 2020, 28 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Jan 29, 2018
StartActual
Feb 2, 2018
Primary completionActual
Jul 1, 2020
CompletionActual
Jul 1, 2020
Last update
Jan 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413917
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Feb 2, 2018
Primary completion
Jul 1, 2020
Completion
Jul 1, 2020
Last update
Jan 26, 2026

Study contacts

Jack Stecher, MD
principal investigator · Baylor Univeristy Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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