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Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02912403
Recruitment Status : Withdrawn (Unable to enroll)
First Posted : September 23, 2016
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Goldkamp, MD, St. Louis University

Brief Summary:
Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.

Condition or disease
Normotensive Postpartum Cesarean Section Patients

Detailed Description:

Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.

All of these procedures are part of the study.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
Estimated Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Postpartum Cesarean Section
We will be including postpartum women as this study idea is pertaining to recent pregnancy



Primary Outcome Measures :
  1. blood pressure changes on days 3 to 6 of the postpartum period [ Time Frame: days 3 to 6 of the postpartum period ]
    To determine the normal blood pressure trends for women with uncomplicated pregnancies during days 3 to 6 of the postpartum period. These days are historically considered the "at risk days" for rising blood pressures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
postpartum women
Criteria

Inclusion Criteria:

  • Normotensive postpartum women
  • Singleton pregnancy
  • Cesarean delivery

Exclusion Criteria:

  • Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)
  • Current diagnosis of hypertensive disease
  • Skin rash in location of cuff placement
  • Tobacco user
  • Chronic narcotic user
  • Vaginal delivery
  • cognitively impaired persons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912403


Locations
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United States, Missouri
St. Mary's Health Center
St Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Jennifer Goldkamp, MD St. Louis University
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Responsible Party: Jennifer Goldkamp, MD, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT02912403    
Other Study ID Numbers: 27285
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No