Exploration and Determination of Genomic Markers Predictive of Uterine Atony

NCT ID: NCT03413917

Last Updated: 2018-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-02

Study Completion Date

2019-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uterine Atony

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

patients who are admitted for repeat cesarean delivery with bilateral tubal ligation who do not develop uterine atony

Analysis of genomic markers in uterine atony

Intervention Type 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.

Study group

Patients who develop uterine atony either during cesarean delivery or who require surgical management of atony after delivery

Analysis of genomic markers in uterine atony

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jack Stecher, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Univeristy Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baylor Univeristy Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jack Stecher, MD

Role: CONTACT

214-820-2126

Shannon Miller, DO

Role: CONTACT

719-522-3805

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jack Stecher, MD

Role: primary

214-820-2126

Shannon Miller, DO

Role: backup

719-522-3805

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28847750 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

017-356

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maternal-fetal Immune Responses to Fetal Surgery
NCT04484441 ACTIVE_NOT_RECRUITING
Muscle Function After Childbirth
NCT05073224 RECRUITING NA