- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02912403
Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
Studieoversikt
Status
Detaljert 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.
Studietype
Kontakter og plasseringer
Studiesteder
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Missouri
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St Louis, Missouri, Forente stater, 63117
- St. Mary's Health Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 27285
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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