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Late Pregnancy Sample Collection Study

Late Pregnancy Sample Collection Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04010682
Enrollment
19
Registered
2019-07-08
Start date
2019-06-20
Completion date
2020-04-23
Last updated
2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Brief summary

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.

Detailed description

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.

Interventions

no drug/devise intervention. sample collection study only

Sponsors

SPD Development Company Limited
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
late pregnancy urine samples4 weeksNumber of volunteers providing daily urine samples from 36 weeks pregnant until birth.

Secondary

MeasureTime frameDescription
pregnancy complications6 weeksNumber of participants reporting pregnancy complications from week 36 of pregnancy until birth
Live birth6 weeksnumber of study participants who's pregnancy resulted in a live birth
Spontaneous vaginal delivery6 weeksnumber of study participants who's pregnancy resulted in a spontaneous vaginal delivery
weight of baby6 weeksweight of baby in pounds and ounces or kilograms
multiple births6 weeksnumber of pregnancies resulting in single baby, twins or triplets.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026