Transthoracic Echocardiography of Ventricular Function of Parturients in Labor

November 13, 2024 updated by: Leigh C. Hickerson, Dartmouth-Hitchcock Medical Center

Transthoracic Echocardiography of Cardiac Function of Parturients in Labor

This echocardiography study will characterize heart structure and function during labor. Imaging of the heart during the stress of labor could increase detection of subclinical cardiovascular disease using advanced imaging techniques. Cardiac serum biomarkers and complication rates will also be measured and compared between patients with and without evidence of cardiovascular disease on echocardiography.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
        • Dartmouth-Hitchcock Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy women between 18 and 35 years of age with singleton pregnancy in active labor

Description

Inclusion Criteria:

  • All healthy parturients 18 years of age or older with estimated gestation greater than or equal to 37 weeks who are expected to deliver during their hospitalization.
  • During the echocardiographic exam, the patient must be in active labor with cervical dilation between 6-10 cm and contractions that are spaced less than 5 minutes apart.

Exclusion Criteria:

  • Known functional or structural heart disease
  • Previously diagnosed pulmonary hypertension.
  • Comorbid disease other than diet controlled gestational diabetes, uncomplicated obesity, mild asthma and euthyroid patients with a history of hypo or hyperthyroidism.
  • Parturients endorsing active use of non-prescription mind-altering drugs including cocaine, methamphetamine, or ketamine.
  • Other non-inclusion criteria include inability to tolerate left lateral positioning either symptomatically or by fetal heart rate monitoring, suspected hypo-or hypercoagulable states that was not previously diagnosed, hemodynamic instability requiring >2 L crystalloid administration within 1 hour time frame after epidural placement or vasopressor administration of >15 mg ephedrine or >300 mcg phenylephrine administration within 1 hour after epidural placement.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The proportion of patients with an abnormal strain pattern as compared to parturients not in labor
Time Frame: During echocardiogram procedure
Left ventricular strain
During echocardiogram procedure
The proportion of patients with diastolic dysfunction as compared to parturients not in labor
Time Frame: During echocardiogram procedure
Abnormal diastolic function
During echocardiogram procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimated right ventricular systolic pressure
Time Frame: During echocardiogram procedure
Comparing estimated right ventricular systolic pressure between patients in active labor as compared to those who are not in active labor (mm Hg)
During echocardiogram procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Left ventricular myocardial performance index
Time Frame: During echocardiogram procedure
During echocardiogram procedure
Total number of patients with the presence of regional wall motion abnormalities
Time Frame: During echocardiogram procedure
During echocardiogram procedure
Total number of patients with abnormal global right ventricular dysfunction
Time Frame: During echocardiogram procedure
During echocardiogram procedure
Tricuspid annular plane systolic excursion
Time Frame: During echocardiogram procedure
centimeters
During echocardiogram procedure
Tissue doppler s'
Time Frame: During echocardiogram procedure
cm/sec
During echocardiogram procedure
Total number of maternal deaths within 0-42 days post-partum
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The number of patients with an identifiable Centers for Disease Control Severe Maternal Morbidity Identification complication post-partum
Time Frame: 0 to 42 days post-partum
Acute myocardial infarction, aortic aneurysm, acute renal failure, adult respiratory distress syndrome, amniotic fluid embolism, cardiac arrest, ventricular fibrillation, conversion of cardiac rhythm, disseminated intravascular coagulation, eclampsia, heart failure, arrest during surgery or procedure, puerperal cerebrovascular disorders, pulmonary edema, aspiration, cardiopulmonary anesthesia complications, sepsis, shock, air or thrombotic embolism, blood product transfusion, hysterectomy, temporary tracheostomy, requiring ventilation
0 to 42 days post-partum
The number of patients with a pulse oximetry reading <90% after delivery
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The number of patients who required oxygen administration after delivery
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The number of patients who develop atrial fibrillation or premature atrial complexes
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The number of patients who develop a stroke
Time Frame: 0 to 42 days post-partum
Stroke must be verified by imaging including either computed tomography or magnetic resonance imaging.
0 to 42 days post-partum
The number of patients with an elevation in transaminase levels during labor or after delivery
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
Hospital length of stay
Time Frame: 0 to 42 days post-partum
Total hours from admission to discharge
0 to 42 days post-partum
The number of patients requiring intensive care unit admission within 42 days post delivery
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
Mortality within 42 days post delivery
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The number of patients with a post-partum diagnosis of post-partum hemorrhage
Time Frame: 0 to 42 days post-partum
0 to 42 days post-partum
The total number of patients who require additional uterotonic medications other than oxytocin after delivery
Time Frame: 0 to 42 days post-partum
Medications include additional dosage of oxytocin above 3 units, methylergonovine, carboprost, tranexamic acid or misoprostol
0 to 42 days post-partum
The number of patients requiring a transfusion
Time Frame: 0 to 42 days post-partum
Cell Saver, red blood cells, platelets, fresh frozen plasma, cryoprecipitate
0 to 42 days post-partum
Blood loss
Time Frame: 0 to 42 days post-partum
Estimated and quantitated blood loss as well as the difference between pre-delivery hemoglobin and post-delivery lowest hemoglobin during admission
0 to 42 days post-partum
Number of patients requiring vasopressor after delivery to support blood pressure
Time Frame: 0 to 42 days post-partum
phenylephrine, ephedrine, norepinephrine, epinephrine, vasopressin, inhaled nitrous oxide, inhaled epoprostenol
0 to 42 days post-partum
Activin A level
Time Frame: Less than 3 hours after echocardiogram procedure
Less than 3 hours after echocardiogram procedure
Placental Growth Factor
Time Frame: Less than 3 hours after echocardiogram procedure
Less than 3 hours after echocardiogram procedure
Soluble endoglin
Time Frame: Less than 3 hours after echocardiogram procedure
Less than 3 hours after echocardiogram procedure
Left ventricular systolic function
Time Frame: During echocardiogram procedure
Simpson's method of discs motion abnormalities and diastolic function
During echocardiogram procedure
Right ventricular strain
Time Frame: During echocardiogram procedure
%
During echocardiogram procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D20144

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

product manufactured in and exported from the U.S.

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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