Exploration and Determination of Genomic Markers Predictive of Uterine Atony

July 16, 2018 updated by: Baylor Research Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Univeristy Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jack Stecher, MD
        • Sub-Investigator:
          • Shannon Miller, DO
        • Sub-Investigator:
          • Ajay Goel, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-12 months
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.
6-12 months
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.
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Jack Stecher, MD, Baylor Univeristy Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 15, 2019

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017-356

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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