Late Pregnancy Sample Collection Study
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|ClinicalTrials.gov Identifier: NCT04010682|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment|
|Pregnancy||Other: urine sample collection|
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 Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Late Pregnancy Sample Collection Study|
|Actual Study Start Date :||June 20, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
- Other: urine sample collection
no drug/devise intervention. sample collection study only
- late pregnancy urine samples [ Time Frame: 4 weeks ]Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.
- pregnancy complications [ Time Frame: 6 weeks ]Number of participants reporting pregnancy complications from week 36 of pregnancy until birth
- Live birth [ Time Frame: 6 weeks ]number of study participants who's pregnancy resulted in a live birth
- Spontaneous vaginal delivery [ Time Frame: 6 weeks ]number of study participants who's pregnancy resulted in a spontaneous vaginal delivery
- weight of baby [ Time Frame: 6 weeks ]weight of baby in pounds and ounces or kilograms
- multiple births [ Time Frame: 6 weeks ]number of pregnancies resulting in single baby, twins or triplets.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010682
|Contact: Sharon Bondfirstname.lastname@example.org|
|Contact: Pauline Parsonsemail@example.com|
|SPD Development Company Ltd||Recruiting|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|
|Contact: Pauline A Parsons +44 (01234) 835398 firstname.lastname@example.org|
|Contact: Sharon Bond +44 (01234) 835000 email@example.com|
|Principal Investigator: Pauline A Parsons|
|Study Director:||Sarah Johnson||SPD Development company Ltd.|