- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02912403
Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Missouri
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St Louis, Missouri, Forenede Stater, 63117
- St. Mary's Health Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Postpartum Cesarean Section
We will be including postpartum women as this study idea is pertaining to recent pregnancy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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blood pressure changes on days 3 to 6 of the postpartum period
Tidsramme: days 3 to 6 of the postpartum period
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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.
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days 3 to 6 of the postpartum period
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 27285
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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