Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Limiting Adverse Birth Outcomes in Resource-Limited Settings (LABOR)

26. september 2022 opdateret af: University of North Carolina, Chapel Hill

Limiting Adverse Birth Outcomes in Resource-Limited Settings - The LABOR Study

The primary objective of this research is to exhaustively document the course and outcomes of hospitalization, labor, delivery, and early postpartum course of up to 15,000 mother-newborn pairs in settings where the occurrence of adverse outcomes is high. The Investigators will gather detailed laboratory, physiologic, and clinical information, and precisely characterize major adverse diagnoses and outcomes. The resulting high-quality, granular, and generalizable data will be used to develop new algorithms to signal actionable intrapartum diagnoses and prospectively stratify women according to their risk for adverse maternal and neonatal outcomes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective multi-country cohort study of up to 15,000 women admitted to the hospital for delivery or for management of respiratory infection. Women will be recruited and screened for study participation at the time of presentation to the hospital. Participants will be assessed through hospitalization, labor, delivery, and discharge and at 1- and 6-week postpartum contacts. Liveborn infants will be enrolled at birth and followed through 42 days of life. The pilot phase of this protocol will enroll up to 500 women in labor and their newborns and follow them through labor, delivery, and 42 days postpartum.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

12020

Kontakter og lokationer

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

Studiesteder

  • Ghana
      • Accra, Ghana
        • Korle Bu Teaching Hospital,
  • Indien
    • Karnataka
      • Belgaum, Karnataka, Indien
        • Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research
    • Odisha
      • Balasore, Odisha, Indien
        • Fakir Mohan Medical College and Hospital
  • Zambia
      • Lusaka, Zambia
        • Women and Newborn Hospital at University Teaching Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Pregnant women and their fetuses/newborns at the Women and Newborn Hospital of the University Teaching Hospital in Lusaka, Zambia; Korle-bu Teaching Hospital in Accra, Ghana; Jawaharlal Nehru Medical College Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research in Belagavi, Karnataka India; and Fakir Mohan Medical College and Hospital in Balasore, Odisha, India.

Beskrivelse

Inclusion Criteria for women enrolled:

  • Maternal age of majority
  • Intrauterine singleton pregnancy

  • Admission to the hospital for ANY of the following:

    1. vaginal delivery
    2. cesarean delivery in the presence of signs/symptoms of parturition, elevated blood pressure, or fever
    3. management of respiratory infection*
  • Ability and willingness to provide written informed consent
  • Willingness to adhere to study procedures

  • Willingness to provide locator information for follow-up

    • Inclusion of participants admitted to hospital for management of respiratory infection applicable to Zambia site only.

Exclusion Criteria for women enrolled:

  • Admission to the hospital for cesarean delivery in the absence of signs/symptoms of parturition, elevated blood pressure, or fever
  • Any condition (social or medical) that, in the opinion of study staff, would make participation unsafe or not feasible. Study staff may note physical, psychological, or social conditions that are not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.

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
Pregnant Women
Up to 15,000 pregnant women and their fetuses/newborns (including a pilot phase of up to 500 participant pairs)
Andet: Observation
Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of cases of maternal death or severe morbidity
Tidsramme: enrollment - 42 days postpartum
Maternal composite: The combined number of maternal death or incident severe morbidity arising from hemorrhage, hypertension, or infection
enrollment - 42 days postpartum
Number of cases of neonatal death or severe morbidity
Tidsramme: enrollment - 42 days postpartum
Fetal/Neonatal Composite: The combined number of Intrapartum stillbirths, neonatal deaths, neonatal encephalopathy, or neonatal sepsis
enrollment - 42 days postpartum

Samarbejdspartnere og efterforskere

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

Sponsor

University of North Carolina, Chapel Hill

Samarbejdspartnere

Bill and Melinda Gates Foundation

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)

31. oktober 2019

Primær færdiggørelse (Faktiske)

8. august 2022

Studieafslutning (Faktiske)

20. september 2022

Datoer for studieregistrering

Først indsendt

23. september 2019

Først indsendt, der opfyldte QC-kriterier

23. september 2019

Først opslået (Faktiske)

25. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. september 2022

Sidst verificeret

1. februar 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19-0765
  • Z 31902 (Anden identifikator: UNC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual data that support the study results will be shared within 6 months of the publication of primary results. As this is a multi-country study with data sharing governed by multiple research ethics and governmental oversight entities, data sharing will be subject to each country providing individual approval in accordance with its own local regulatory requirements.

IPD-delingstidsramme

Deidentified individual data that supports the study results will be shared within 6 months of the publication of primary results.

IPD-delingsadgangskriterier

See plan description

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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 Luftvejsinfektion

Kliniske forsøg med Observation

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in China

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner