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

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.

Study Overview

• Status: Withdrawn
• Conditions: 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

postpartum women

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure changes on 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.	days 3 to 6 of the postpartum period

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: March 3, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 27285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO