NCT03413917

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2.4 years

First QC Date

October 31, 2017

Last Update Submit

January 23, 2026

Conditions

Uterine Atony

Keywords

genomic markers

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6-12 months

Study Arms (2)

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

Analysis of genomic markers in uterine atonyOTHER

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

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOur study is to examine genomic markers in uterine atony, thus our subjects must have a uterus.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • under 18 years of age
  • prisoners
  • non-female sex
  • cannot provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Univeristy Medical Center

Dallas, Texas, 75246, United States

Location

Related Publications (1)

  • 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.

    PMID: 28847750BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

uterine myometrium, blood

MeSH Terms

Conditions

Uterine Inertia

Condition Hierarchy (Ancestors)

DystociaObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jack Stecher, MD

    Baylor Univeristy Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2017

First Posted

January 29, 2018

Study Start

February 2, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)