Late Pregnancy Sample Collection Study
This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. All urine samples will be stored and used for research or product validation purposes.
The study will also gather information from volunteers regarding a woman's health during her pregnancy.
Studieoversigt
Detaljeret beskrivelse
This study will obtain daily urine samples from pregnant volunteers, from 36 weeks pregnant until birth. It is anticipated 20-40 pregnant women will be recruited to the study.
Urine samples will be delivered to SPD either via post, or by hand and form part of the SPD BioBank. All urine samples will be stored and used for research or product validation purposes.
The study will also gather information from volunteers regarding a woman's health during her pregnancy, including any bleeding, discharge, discomfort, contractions/ Braxton Hicks via the use of a daily diary.
Pregnancy outcome details including labour specifics and birth outcomes such as birth date, weight, and sex of the baby will be obtained 4-6 weeks after the volunteer has given birth via email correspondence between the volunteer and study co-ordinator.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bedfordshire
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Bedford, Bedfordshire, Det Forenede Kongerige, MK44 3UP
- SPD Development Company Ltd
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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:
- Pregnant female in 3rd trimester of pregnancy
Exclusion Criteria:
- Prescribed bed-rest during third trimester or any other pregnancy
- complication that would affect the ability to participate in the study
- more than 38 weeks pregnant
- Have a planned caesarean section
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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late pregnancy urine samples
Tidsramme: 4 weeks
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Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.
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4 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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pregnancy complications
Tidsramme: 6 weeks
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Number of participants reporting pregnancy complications from week 36 of pregnancy until birth
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6 weeks
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Live birth
Tidsramme: 6 weeks
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number of study participants who's pregnancy resulted in a live birth
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6 weeks
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Spontaneous vaginal delivery
Tidsramme: 6 weeks
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number of study participants who's pregnancy resulted in a spontaneous vaginal delivery
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6 weeks
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weight of baby
Tidsramme: 6 weeks
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weight of baby in pounds and ounces or kilograms
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6 weeks
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multiple births
Tidsramme: 6 weeks
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number of pregnancies resulting in single baby, twins or triplets.
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6 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
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
- PROTOCOL-1095
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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