PregnancyNCT04010682
Late Pregnancy Sample Collection Study
An observational study of Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- urine sample collection
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jun 2019to 23 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy pregnant volunteers
Who may be able to join
- Pregnant female in 3rd trimester of pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd
Bedford, Bedfordshire, MK44 3UP
About this 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- urine sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine sample collectionOther
no drug/devise intervention. sample collection study only
What is being measured
The primary outcome is the main question the study is designed to answer.
late pregnancy urine samples
Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.
Measured: 4 weeks
Secondary outcomes (5)
pregnancy complications
Number of participants reporting pregnancy complications from week 36 of pregnancy until birth
Measured: 6 weeks
Live birth
number of study participants who's pregnancy resulted in a live birth
Measured: 6 weeks
Spontaneous vaginal delivery
number of study participants who's pregnancy resulted in a spontaneous vaginal delivery
Measured: 6 weeks
weight of baby
weight of baby in pounds and ounces or kilograms
Measured: 6 weeks
multiple births
number of pregnancies resulting in single baby, twins or triplets.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start20 Jun 2019
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, SPD Development company Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010682
- Sponsor's protocol ID
- PROTOCOL-1095
- Status last verified
- May 2022
- First submitted
- 19 Jun 2019
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Pregnancy Sample Collection Study
- ClinicalTrials.gov ID
- NCT04010682
- Acronym / sponsor ID
- PROTOCOL-1095
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy pregnant volunteers
Key inclusion criteria (1 listed)
- Pregnant female in 3rd trimester of pregnancy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine sample collectionno drug/devise intervention. sample collection study only | Other | – |
Primary outcome
late pregnancy urine samples
Time frame: 4 weeks
Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.
5 secondary outcomes
pregnancy complications
Time frame: 6 weeks
Live birth
Time frame: 6 weeks
Spontaneous vaginal delivery
Time frame: 6 weeks
weight of baby
Time frame: 6 weeks
multiple births
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson study director
SPD Development company Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late pregnancy urine samples (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.