Late Pregnancy Sample Collection Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04010682|
Recruitment Status : Suspended (sufficient volunteer recruited for the moment. Study may be re-opened at a later date)
First Posted : July 8, 2019
Last Update Posted : October 8, 2020
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 2021|
|Estimated Study Completion Date :||December 2021|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010682
|SPD Development Company Ltd|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|
|Study Director:||Sarah Johnson||SPD Development company Ltd.|