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Retrospective Review of NSAIDS in the Postpartum Period

8. november 2017 opdateret af: Jennifer Goldkamp, MD, St. Louis University

Hypertension and NSAIDS in the Postpartum Period

Chart review of women who have delivered an infant in a single health care system to determine if NSAID use increases blood pressures in the postpartum period.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most common medication used for pain relief in the postpartum period in the United States. For pain relief of uterine involution, NSAIDs have shown to be superior to placebo, and equivalent or superior to narcotics. In 2013 the American College of Obstetricians and Gynecologists (ACOG) discouraged the use of NSAIDs in women with pre-eclampsia due to concerns for inadvertently increasing blood pressure. This recommendation is based on non-obstetrics literature, which tended to show a small increase of blood pressures in patients who use NSAIDS. However the literature is mixed, particularly on ibuprofen which is the most common NSAID used in the postpartum. Of the two meta-analysis that are commonly referenced, Pope et al found a decrease of -0.3 (+/- 2.57) mmHg in mean arterial pressure (MAP) in patients with hypertension treated with ibuprofen, and Johnson et al identified an average of 5mmHg increase in blood pressure with ibuprofen use. A large study of 18,325 patients who were treated with NSAIDS or COX-2 inhibitors, found an average of a 2.1 (+/- 0.5) mmHg increase in blood pressure with ibuprofen administration.

There are two articles available in the obstetrics literature on the topic of NSAIDS in women with hypertension disorders. The first is by Makis et al, and is a case series of six women, with discussion of two cases. The explanations of hypertension causes are limited and possible alternate diagnoses are not discussed (6). The second by Wasden et al is a retrospective study of women who had the diagnosis of severe hypertension disorders in pregnancy. The patients were matched 2:1 for women exposed to NSAIDs versus those who did not receive NSAIDs. MAPs were compared, and there was no difference found between the two groups. This second study is better designed and is likely representative of the true outcome of NSAID use in pre-eclamptic women, as the general literature shows a small, non-clinically significant change in blood pressure readings.

Undersøgelsestype

Observationel

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63117
        • St. Mary's Health Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 45 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

pregnant, All ethnic backgrounds will be included.

Beskrivelse

Inclusion Criteria:

  • received NSAIDs post delivery for pain

Exclusion Criteria:

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
NSAID use
The purpose of this study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.
The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pain relief
Tidsramme: 1 year
to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. januar 2017

Primær færdiggørelse (Forventet)

1. april 2018

Studieafslutning (Forventet)

1. april 2019

Datoer for studieregistrering

Først indsendt

18. januar 2017

Først indsendt, der opfyldte QC-kriterier

18. januar 2017

Først opslået (Skøn)

20. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 26975

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Post Partum Pain

Kliniske forsøg med NSAID use

3
Abonner