NCT04010682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 20, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2020

Completed
Last Updated

May 4, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

June 19, 2019

Last Update Submit

May 3, 2022

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • late pregnancy urine samples

    Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.

    4 weeks

Secondary Outcomes (5)

  • pregnancy complications

    6 weeks

  • Live birth

    6 weeks

  • Spontaneous vaginal delivery

    6 weeks

  • weight of baby

    6 weeks

  • multiple births

    6 weeks

Interventions

urine sample collectionOTHER

no drug/devise intervention. sample collection study only

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy pregnant volunteers

You may qualify if:

  • Pregnant female in 3rd trimester of pregnancy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Daily urine samples collected

Study Officials

  • Sarah Johnson

    SPD Development company Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 8, 2019

Study Start

June 20, 2019

Primary Completion

April 23, 2020

Study Completion

April 23, 2020

Last Updated

May 4, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)