"Treatment Use of ECMO In Pregnancy or Peripartum Patient."

November 19, 2020 updated by: Sarah Thordsen
The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

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

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

Women treated with ECMO while pregnant or immediately postpartum (within six months).

Description

Inclusion Criteria:

  1. Female
  2. Age 18 years or greater at the time of ECMO treatment.
  3. Pregnant or within 6 months post-partum at the time of ECMO cannulation

Exclusion Criteria:

  1. No history of pregnancy.
  2. No treatment with ECMO.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiogenic Shock Treated with ECMO
This cohort of participants required clinical intervention with ECMO for treatment of their index cardiogenic shock episode while pregnant or post delivery of their infant.
Device: Extracorporeal Membrane Oxygenation
Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcome of Mother
Time Frame: Time of diagnosis -Six Month Survival Rate
Describe clinical course of pregnant or recently postpartum patients with cardiogenic shock treated with ECMO, including the rate of neonate survival
Time of diagnosis -Six Month Survival Rate

Collaborators and Investigators

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

Sponsor

Sarah Thordsen

Collaborators

Medical College of Wisconsin

Investigators

  • Principal Investigator: Sarah Thordsen, MD, Medical College of Wisconsin

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)

October 28, 2019

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 23, 2020

Last Update Submitted That Met QC Criteria

November 19, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00036221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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