NCT04144660

Brief Summary

The goal of this study is to describe the use of ECMO (Extracorporeal Membrane Oxygenation) in the pregnant or peripartum patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

October 28, 2019

Last Update Submit

November 19, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcome of Mother

    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

Study Arms (1)

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

Interventions

Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.

Cardiogenic Shock Treated with ECMO

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No history of pregnancy.
  • No treatment with ECMO.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Shock, CardiogenicPeripartum CardiomyopathyPregnancy Complications

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockPregnancy Complications, CardiovascularFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCardiomyopathies

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Sarah Thordsen, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Cardiovascular Medicine

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

October 28, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations