Late Pregnancy Sample Collection Study

NCT ID: NCT04010682

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-20

Study Completion Date

2020-04-23

Brief Summary

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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

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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urine sample collection

no drug/devise intervention. sample collection study only

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Johnson

Role: STUDY_DIRECTOR

SPD Development company Ltd.

Locations

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SPD Development Company Ltd

Bedford, Bedfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-1095

Identifier Type: -

Identifier Source: org_study_id

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