Forebyggelse af jernmangelanæmi efter fødslen (PRIORITY)
29. juni 2026 opdateret af: NICHD Global Network for Women's and Children's Health
Forebyggelse af jernmangelanæmi Post-levering (PRIORITY Trial): Et randomiseret kontrolleret forsøg af det globale netværk for kvinders og børns sundhedsforskning
PRIORITY er designet som et 2-arms, randomiseret-kontrolleret forsøg med fokus på postpartum kvinder.
Forsøget vil rekruttere kvinder, der er diagnosticeret med moderat anæmi baseret på en blodprøve taget 6-48 timer efter fødslen.
I alt 4.800 kvalificerede kvinder, eller 600 kvinder pr. forskningssted, vil blive godkendt og tilmeldt forsøget.
Undersøgelsen antager, at 6 uger efter fødslen, vil prævalensen af den ikke-anæmiske tilstand hos kvinder, der modtog en enkeltdosis IV jerninfusion mellem 6 og 48 timer efter fødslen og før udskrivelsen fra institutionen, være større end kvinder, der fik en forsyning af orale jerntabletter taget to gange dagligt i 6 uger.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIORITY er et 2-arm, randomiseret-kontrolleret forsøg, der vil blive implementeret på 8 steder i 7 lande: Bangladesh, Den Demokratiske Republik Congo, Guatemala, Indien (Nagpur og Belagavi), Kenya, Pakistan og Zambia.
Forskerholdet for hvert sted vil tilmelde cirka 600 kvinder, der føder på et hospital eller en anden facilitet, såsom et sundhedscenter med leveringstjenester.
Deltagerne vil blive randomiseret til at modtage en enkeltdosis IV jerninfusion mellem 6 og 48 timer efter fødslen før udskrivelse fra institutionen eller orale jerntabletter taget to gange dagligt i 6 uger.
De vil derefter blive vurderet af forskningspersonale på en passende sundhedsfacilitet 6 uger og 6 måneder efter fødslen ved at levere en moderblodprøve, som vil blive analyseret for at bestemme Hb-koncentrationen.
Ved hvert studiebesøg vil uddannet personale også måle serumferritin, serumtransferrinreceptor, C-reaktivt protein (CRP) og alfa 1-syreglycoprotein (AGP).
Derudover vil der på de afrikanske forskningssteder blive givet en hurtig diagnostisk test (RDT) for malaria ved indlæggelse på fødestedet og 6 uger og 6 måneder efter fødslen.
Edinburgh Postnatal Depression Scale (EPDS), World Health Organization Quality-of-Life (QOL) skalaen, The Maternal Fatigue Severity Scale (FSS-5R) og The Mother-to-infant Bonding Scale (MIBS) vil også blive brugt 6 uger og 6 måneder efter fødslen opfølgningsaftaler for at indsamle data til sekundære undersøgelsesformål. Studiet antager, at 6 uger efter fødslen var prævalensen af den ikke-anæmiske tilstand hos kvinder, der modtog en enkeltdosis IV jerninfusion mellem 6 og 48 timer efter fødslen og før udskrivelsen fra institutionen vil være større end for kvinder, der får en forsyning af orale jerntabletter taget to gange dagligt i 6 uger.
Sekundære undersøgelsesformål vil se på virkningerne af postpartum depression på moderens livskvalitet, træthed og amningsstart og -retentionsrater.
Depression er også en risikofaktor for at reducere spædbarn-mor-binding.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
4857
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Dhaka, Bangladesh, 1212
- Icddrb
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Kinshasa, Den demokratiske republik Congo
- Kinshasa School of Public Health
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Guatemala City, Guatemala
- INCAP
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India
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Nagpur, India, Indien
- Lata Medical Research Foundation
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Karnataka
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Belagavi, Karnataka, Indien, 590 010
- KLE Society's Jawaharlal Nehru Medical College
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Eldoret, Kenya, 30100
- Moi University School of Medicine
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Pakistan
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Karachi, Pakistan, Pakistan, 74800
- The Aga Khan University
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Lusaka, Zambia
- University Teaching Hospital
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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
15 år til 49 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Etableret graviditet >20 ugers svangerskab ved LMP og/eller klinisk vurdering og/eller USG
- Alder: 15 år (eller lavere aldersgrænse *) til 49 år
- Bekræftet moderat anæmi (Hb 7,0 til 9,9 g/dL, 6-48 timer efter fødslen baseret på en venøs blodprøve på Hemocue®)
- Aflever på deltagende studiehospital eller sundhedsinstitution
- Kan give informeret samtykke
- Planlægger at forblive i studieområdet under undersøgelsens varighed
Ekskluderingskriterier:
- IV jerninfusion modtaget inden for de seneste 3 uger
- Kontraindikation til jerntilskud (nogle eksempler kan omfatte hæmolytisk anæmi, allergi, alvorlig infektion)
- Blodtransfusion allerede modtaget eller planlagt under den aktuelle hospitalsindlæggelse
- Kendt diagnose af allerede eksisterende depression eller anden psykiatrisk sygdom
- Dødfødsel, større medfødt anomali eller neonatalt tab før randomisering
- Kvinder testet positive og tidligere ubehandlet for malaria
- Præsenterer med symptomatisk anæmi med dyspnø eller træthed og behov for øjeblikkelig korrektion
- Kvinder med kendt hæmoglobinopati (seglcellesygdom eller thalassæmi)
- Tilstedeværelse af alvorlige allergiske tilstande såsom svær astma eller kendte lægemiddelallergier
- Kvinder med enhver sygdom/tilstand, der kræver øjeblikkelig lægehjælp efter lægens vurdering
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: IV iron infusion
Participants randomized to the IV iron arm will receive a single-dose infusion of IV FCM, to be initiated between 6-48 hours after delivery.
All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.
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FCM 50 mg iron/mL will be in a solution of 20 mL vials for infusion, using a dosage of 20 mg elemental iron per kg body weight, up to a maximum of 1 g, in a single IV infusion over 20-30 minutes.
400 mcg of folic acid daily to 6 months.
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Aktiv komparator: Oral iron tablets
Participants randomized to the oral iron arm will receive 60 mg elemental iron twice daily.
Treatment will be initiated between 6-48 hours after delivery and prior to discharge from the facility.
After discharge, each participant will take a treatment dose of twice daily for 6 weeks postpartum.
At 6 weeks postpartum, serum Hb will be assessed and participants with Hb < 7.0 g/dL will stop treatment, participants with Hb 7.0-11.9
g/dL will continue taking 60 mg elemental iron twice daily and participants with Hb > 11.9 g/dL will take 60 mg elemental iron once daily.
All randomized participants will receive 400 mcg of folic acid daily for 6 months postpartum.
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60 mg elemental iron twice daily to 6-weeks with then once or twice daily (based on Hb at 6-weeks) to 6-months.
400 mcg of folic acid daily to 6 months.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Maternal non-anemic state (Hb ≥11 g/dL)
Tidsramme: 6 weeks post-delivery
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6 weeks post-delivery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from baseline in serum Hb concentration at 6-weeks postpartum
Tidsramme: 6 weeks post-delivery
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Serum Hb at baseline subtracted from serum Hb at 6 weeks.
Key secondary outcome.
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6 weeks post-delivery
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Maternal depression at 6-weeks postpartum
Tidsramme: 6 weeks post-delivery
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Measured by Edinburgh Postnatal Depression Scale score > 10.
A score greater than 10 indicates a higher likelihood of depression.
Key secondary outcome.
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6 weeks post-delivery
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Change from baseline in serum Hb concentration at 6-months postpartum
Tidsramme: 6 months post-delivery
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Serum Hb at baseline subtracted from serum Hb at 6 months.
Key secondary outcome.
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6 months post-delivery
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Maternal depression at 6-months postpartum
Tidsramme: 6 months post-delivery
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Measured by Edinburgh Postnatal Depression (EPDS) Scale score > 10.
A score greater than 10 indicates a higher likelihood of depression.
Key secondary outcome.
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6 months post-delivery
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Maternal Fatigue Severity Scale Score > 4
Tidsramme: 6 weeks and 6 months post-delivery
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Measured by the Maternal Fatigue Severity Scale (FSS-5R) > 4. A score > 4 indicates maternal fatigue.
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6 weeks and 6 months post-delivery
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Mother-to-Infant Bonding Scale Score ≥ 4
Tidsramme: 6 weeks post-delivery
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Measured by the Mother-to-Infant Bonding Scale (MIBS) ≥ 4. A score ≥ 4 indicates worse mother to infant bonding.
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6 weeks post-delivery
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WHOQOL-BREF Overall Perception of Quality of Life score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF overall perception of quality of life score is the response to question 1 from the WHOQOL-BREF survey.
How would you rate your quality of life?
(Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
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6 weeks and 6 months post-delivery
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WHOQOL-BREF Overall Perception of Health score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF overall perception of heath score is the response to question 2 from the WHOQOL-BREF survey.
How satisfied are you with your health?
(Very poor=1; Poor=2; Neither poor nor good=3; Good=4; Very good=5)
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6 weeks and 6 months post-delivery
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WHOQOL-BREF Physical Domain Score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF physical domain score is calculated as: ((6-Q3) + (6-Q4) + Q10 + Q15 + Q16 + Q17 + Q18)/7 x 4. If a participant is missing 2 or more questions in the physical domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF physical domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Psychological Domain Score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF psychological domain score is calculated as: (Q5 + Q6 + Q7 + Q11 + Q19 + (6-Q26))/6 x 4. If a participant is missing 2 or more questions in the psychological domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF psychological domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Social Relationships Domain Score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF social relationships domain score is calculated as: (Q20 + Q21 + Q22)/3 x 4. If a participant is missing 2 or more questions in the social relationships domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF social relationships domain score is set to missing. In the case where one item is missing, the mean of other items in the domain is substituted for the missing question. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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WHOQOL-BREF Environment Domain Score
Tidsramme: 6 weeks and 6 months post-delivery
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The WHOQOL-BREF environment domain score is calculated as: (Q8 + Q9 + Q12 + Q13 + Q14 + Q23 + Q24 + Q25)/8 x 4. If a participant is missing 3 or more questions in the environment domain or 6 or more questions in the WHOQOL-BREF assessment, then the WHOQOL-BREF environment domain score is set to missing. In the case where up to two items are missing, the mean of other items in the domain is substituted for the missing questions. The score is transformed to a 0-100 scale by applying the following formula: (Score-4)*(100/16). |
6 weeks and 6 months post-delivery
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Change from baseline in serum ferritin concentration
Tidsramme: 6 weeks and 6 months post-delivery
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Serum ferritin concentration at baseline subtracted from serum ferritin concentration at 6 weeks and 6 months.
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6 weeks and 6 months post-delivery
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Change from baseline in serum soluble transferrin receptor concentration
Tidsramme: 6 weeks and 6 months post-delivery
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Serum soluble transferrin receptor at baseline subtracted from serum soluble transferrin receptor at 6 weeks and 6 months.
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6 weeks and 6 months post-delivery
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Maternal non-anemic state (Hb ≥11.5 g/dL)
Tidsramme: 6 weeks and 6 months post-delivery
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6 weeks and 6 months post-delivery
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Maternal non-anemic state (Hb ≥12.0 g/dL)
Tidsramme: 6 weeks and 6 months post-delivery
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6 weeks and 6 months post-delivery
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Anemic state
Tidsramme: 6 weeks and 6 months post-delivery
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Anemic state at 6 weeks postpartum defined as no anemia for Hb ≥ 11.0 g/dL, mild anemia for Hb 10.0-10.9
g/dL, moderate anemia for 7.0-9.9
g/dL and severe anemia for Hb < 7.0 g/dL.
Anemic state at 6 months postpartum defined as no anemia for Hb ≥ 12.0 g/dL, mild anemia for Hb 10.0-11.9
g/dL, moderate anemia for 7.0-9.9
g/dL and severe anemia for Hb < 7.0 g/dL.
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6 weeks and 6 months post-delivery
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Change from baseline in anemic state
Tidsramme: 6 weeks and 6 months post-delivery
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Defined as 'Better' if the participant's Hb measurement is > 9.9 g/dL, 'No change' if the participant's Hb measurement is 7.0-9.9
g/dL, and 'Worse' if the participant's Hb measurement is < 7.0 g/dL.
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6 weeks and 6 months post-delivery
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Maternal mortality
Tidsramme: randomization to 6 months post-delivery
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Maternal death from any cause
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randomization to 6 months post-delivery
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Post-discharge blood transfusion
Tidsramme: discharge from delivery facility to 6 months post-delivery
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Blood transfusion given to mother after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Postpartum hemorrhage requiring blood transfusion or major surgery
Tidsramme: randomization to 6 weeks post-delivery
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randomization to 6 weeks post-delivery
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Post-discharge maternal hospitalization
Tidsramme: discharge from delivery facility to 6 months post-delivery
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Maternal admission to facility after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Neonatal/infant mortality
Tidsramme: randomization to 6 months
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Neonatal/infant death from any cause
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randomization to 6 months
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Post-discharge neonatal/infant hospitalization
Tidsramme: discharge from delivery facility to 6 months post-delivery
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Neonatal/infant admission to facility after delivery facility discharge
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discharge from delivery facility to 6 months post-delivery
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Exclusive breastfeeding
Tidsramme: 6 weeks, 3 months and 6 months post-delivery
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Based on WHO/UNICEF definition that measures exclusive feeding with breast milk during the previous day.
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6 weeks, 3 months and 6 months post-delivery
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Hypophosphatemia at 6-weeks postpartum
Tidsramme: 6 weeks post-delivery
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Measured by serum phosphate concentration < 2.5 mg/dL.
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6 weeks post-delivery
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Hypophosphatemia at 6-months postpartum
Tidsramme: 6 months post-delivery
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Measured by serum phosphate concentration < 2.5 mg/dL at 6 months among participants with hypophosphatemia at 6 weeks.
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6 months post-delivery
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Short-term safety outcomes
Tidsramme: randomization to 6 weeks post-delivery
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Measured by at least one serious adverse event reported.
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randomization to 6 weeks post-delivery
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All Safety outcomes
Tidsramme: randomization to 6 months post-delivery
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Measured by at least one serious adverse event reported.
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randomization to 6 months post-delivery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard J Derman, MD, MPH, Thomas Jefferson University, Philadelphia, PA
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
- Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
- Parks S, Hoffman MK, Goudar SS, Patel A, Saleem S, Ali SA, Goldenberg RL, Hibberd PL, Moore J, Wallace D, McClure EM, Derman RJ. Maternal anaemia and maternal, fetal, and neonatal outcomes in a prospective cohort study in India and Pakistan. BJOG. 2019 May;126(6):737-743. doi: 10.1111/1471-0528.15585. Epub 2019 Jan 24.
- Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Sultan P, Bampoe S, Shah R, Guo N, Estes J, Stave C, Goodnough LT, Halpern S, Butwick AJ. Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 Jul;221(1):19-29.e3. doi: 10.1016/j.ajog.2018.12.016. Epub 2018 Dec 19.
- Matsunaga A, Ohashi Y, Sakanashi K, Kitamura T. Factor structure of the Postpartum Bonding Questionnaire: Configural invariance and measurement invariance across postpartum time periods. J Psychiatr Res. 2021 Mar;135:1-7. doi: 10.1016/j.jpsychires.2020.11.017. Epub 2020 Nov 9.
- Taylor A, Atkins R, Kumar R, Adams D, Glover V. A new Mother-to-Infant Bonding Scale: links with early maternal mood. Arch Womens Ment Health. 2005 May;8(1):45-51. doi: 10.1007/s00737-005-0074-z. Epub 2005 May 4.
- Fellmeth G, Harrison S, Opondo C, Nair M, Kurinczuk JJ, Alderdice F. Validated screening tools to identify common mental disorders in perinatal and postpartum women in India: a systematic review and meta-analysis. BMC Psychiatry. 2021 Apr 20;21(1):200. doi: 10.1186/s12888-021-03190-6.
- Shrestha SD, Pradhan R, Tran TD, Gualano RC, Fisher JR. Reliability and validity of the Edinburgh Postnatal Depression Scale (EPDS) for detecting perinatal common mental disorders (PCMDs) among women in low-and lower-middle-income countries: a systematic review. BMC Pregnancy Childbirth. 2016 Apr 4;16:72. doi: 10.1186/s12884-016-0859-2.
- Ali SA, Tikmani SS, Saleem S, Patel AB, Hibberd PL, Goudar SS, Dhaded S, Derman RJ, Moore JL, McClure EM, Goldenberg RL. Hemoglobin concentrations and adverse birth outcomes in South Asian pregnant women: findings from a prospective Maternal and Neonatal Health Registry. Reprod Health. 2020 Nov 30;17(Suppl 2):154. doi: 10.1186/s12978-020-01006-6.
- Jessani S, Saleem S, Hoffman MK, Goudar SS, Derman RJ, Moore JL, Garces A, Figueroa L, Krebs NF, Okitawutshu J, Tshefu A, Bose CL, Mwenechanya M, Chomba E, Carlo WA, Das PK, Patel A, Hibberd PL, Esamai F, Liechty EA, Bucher S, Nolen TL, Koso-Thomas M, Miodovnik M, McClure EM, Goldenberg RL. Association of haemoglobin levels in the first trimester and at 26-30 weeks with fetal and neonatal outcomes: a secondary analysis of the Global Network for Women's and Children's Health's ASPIRIN Trial. BJOG. 2021 Aug;128(9):1487-1496. doi: 10.1111/1471-0528.16676. Epub 2021 Apr 12.
- Patel A, Prakash AA, Das PK, Gupta S, Pusdekar YV, Hibberd PL. Maternal anemia and underweight as determinants of pregnancy outcomes: cohort study in eastern rural Maharashtra, India. BMJ Open. 2018 Aug 8;8(8):e021623. doi: 10.1136/bmjopen-2018-021623.
- Rioux FM, Savoie N, Allard J. Is there a link between postpartum anemia and discontinuation of breastfeeding? Can J Diet Pract Res. 2006 Summer;67(2):72-6. doi: 10.3148/67.2.2006.72.
- Babu GR, Murthy GVS, Singh N, Nath A, Rathnaiah M, Saldanha N, Deepa R, Kinra S. Sociodemographic and Medical Risk Factors Associated With Antepartum Depression. Front Public Health. 2018 May 2;6:127. doi: 10.3389/fpubh.2018.00127. eCollection 2018.
- Tsai AC, Scott JA, Hung KJ, Zhu JQ, Matthews LT, Psaros C, Tomlinson M. Reliability and validity of instruments for assessing perinatal depression in African settings: systematic review and meta-analysis. PLoS One. 2013 Dec 10;8(12):e82521. doi: 10.1371/journal.pone.0082521. eCollection 2013.
- Khaskheli MN, Baloch S, Sheeba A, Baloch S, Khaskheli FK. Iron deficiency anaemia is still a major killer of pregnant women. Pak J Med Sci. 2016 May-Jun;32(3):630-4. doi: 10.12669/pjms.323.9557.
- Kramer MS, Dahhou M, Vallerand D, Liston R, Joseph KS. Risk factors for postpartum hemorrhage: can we explain the recent temporal increase? J Obstet Gynaecol Can. 2011 Aug;33(8):810-819. doi: 10.1016/S1701-2163(16)34984-2.
- Markova V, Norgaard A, Jorgensen KJ, Langhoff-Roos J. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2015 Aug 13;2015(8):CD010861. doi: 10.1002/14651858.CD010861.pub2.
- Vanobberghen F, Lweno O, Kuemmerle A, Mwebi KD, Asilia P, Issa A, Simon B, Mswata S, Schmidlin S, Glass TR, Abdulla S, Daubenberger C, Tanner M, Meyer-Monard S. Efficacy and safety of intravenous ferric carboxymaltose compared with oral iron for the treatment of iron deficiency anaemia in women after childbirth in Tanzania: a parallel-group, open-label, randomised controlled phase 3 trial. Lancet Glob Health. 2021 Feb;9(2):e189-e198. doi: 10.1016/S2214-109X(20)30448-4. Epub 2020 Nov 24.
- Skevington SM. Measuring quality of life in Britain: introducing the WHOQOL-100. J Psychosom Res. 1999 Nov;47(5):449-59. doi: 10.1016/s0022-3999(99)00051-3.
- Auerbach M, Macdougall I. The available intravenous iron formulations: History, efficacy, and toxicology. Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92. doi: 10.1111/hdi.12560. Epub 2017 Mar 29.
- Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant. 2006 Feb;21(2):378-82. doi: 10.1093/ndt/gfi253. Epub 2005 Nov 11.
- Gomez-Ramirez S, Shander A, Spahn DR, Auerbach M, Liumbruno GM, Vaglio S, Munoz M. Prevention and management of acute reactions to intravenous iron in surgical patients. Blood Transfus. 2019 Mar;17(2):137-145. doi: 10.2450/2018.0156-18. Epub 2018 Oct 16.
- Rampton D, Folkersen J, Fishbane S, Hedenus M, Howaldt S, Locatelli F, Patni S, Szebeni J, Weiss G. Hypersensitivity reactions to intravenous iron: guidance for risk minimization and management. Haematologica. 2014 Nov;99(11):1671-6. doi: 10.3324/haematol.2014.111492.
- Auerbach M, Macdougall IC. Safety of intravenous iron formulations: facts and folklore. Blood Transfus. 2014 Jul;12(3):296-300. doi: 10.2450/2014.0094-14. No abstract available.
- Rebecca Giallo, Catherine Wade & Mandy Kienhuis (2014) Fatigue in mothers of infants and young children: factor structure of the fatigue assessment scale, Fatigue: Biomedicine, Health & Behavior, 2:3, 119-131, DOI: 10.1080/21641846.2014.925326
- Young CA, Mills R, Al-Chalabi A, Burke G, Chandran S, Dick DJ, Ealing J, Hanemann CO, Harrower T, Mcdermott CJ, Majeed T, Pinto A, Talbot K, Walsh J, Williams TL, Tennant A; TONiC study group. Measuring quality of life in ALS/MND: validation of the WHOQOL-BREF. Amyotroph Lateral Scler Frontotemporal Degener. 2020 Jun 27;21(5-6):364-372. doi: 10.1080/21678421.2020.1752244.
Hjælpsomme links
- Sison G. The Morisky Medication Adherence Scale: An Overview. 2018
- Auerbach M. Treatment of iron deficiency anemia in adults. 2020
- Electronic Medicines Compendium (eMC). Monofer 100mg/ml solution for injection/infusion.
- Electronic Medicines Compendium (eMC). Ferinject (ferric carboxymaltose).
- World Health Organization. Anemia
- World Health Organization. Maternal health
- Number of non-pregnant women (aged 15-49 years) with anaemia (thousands)
- World Health Organization. Prevalence of anaemia in pregnant women (aged 15-49) (%).
- World Health Organization. Prevalence of anaemia in women of reproductive age (aged 15-49) (%)
- World Health Organization. The World Health Organization Quality of Life (WHOQOL). 2012.
- World Health Organization. WHA65.6. Comprehensive implementation plan on maternal, infant and young child nutrition as passed by the World Health Assembly at the Sixty-fifth World Health Assembly meeting.2012.
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)
30. maj 2023
Primær færdiggørelse (Faktiske)
10. marts 2025
Studieafslutning (Faktiske)
28. juli 2025
Datoer for studieregistrering
Først indsendt
29. september 2022
Først indsendt, der opfyldte QC-kriterier
19. oktober 2022
Først opslået (Faktiske)
21. oktober 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hæmatologiske sygdomme
- Hemiske og lymfatiske sygdomme
- Anæmi
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Uorganiske kemikalier
- Elementer
- Metaller
- Organophosphorforbindelser
- Pterins
- Pteridiner
- Metaller, tung
- Overgangselementer
- Organophosphonater
- Folinsyre
- Jern
- Fosfomycin
- Ferric carboxymaltose
Andre undersøgelses-id-numre
- CP PRIORITY
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