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

Withdrawn

• Conditions: Normotensive Postpartum Cesarean Section Patients

• Registration Number: NCT02912403
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-06
• Primary Completion: 2017-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood pressure changes on days 3 to 6 of the postpartum period	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.

Trial Locations

Locations (1)

St. Mary's Health Center; 🇺🇸 St Louis, Missouri, United States