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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010682
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited

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.


Condition or disease Intervention/treatment
Pregnancy Other: urine sample collection

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: urine sample collection
    no drug/devise intervention. sample collection study only


Primary Outcome Measures :
  1. late pregnancy urine samples [ Time Frame: 4 weeks ]
    Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.


Secondary Outcome Measures :
  1. pregnancy complications [ Time Frame: 6 weeks ]
    Number of participants reporting pregnancy complications from week 36 of pregnancy until birth

  2. Live birth [ Time Frame: 6 weeks ]
    number of study participants who's pregnancy resulted in a live birth

  3. Spontaneous vaginal delivery [ Time Frame: 6 weeks ]
    number of study participants who's pregnancy resulted in a spontaneous vaginal delivery

  4. weight of baby [ Time Frame: 6 weeks ]
    weight of baby in pounds and ounces or kilograms

  5. multiple births [ Time Frame: 6 weeks ]
    number of pregnancies resulting in single baby, twins or triplets.


Biospecimen Retention:   Samples Without DNA
Daily urine samples collected


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy pregnant volunteers
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Sharon Bond 01234835000 sharon.bond@spdspark.com
Contact: Pauline Parsons 01234835000 pauline.parsons@spdspark.com

Locations
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United Kingdom
SPD Development Company Ltd Recruiting
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Contact: Pauline A Parsons    +44 (01234) 835398    pauline.parsons@spdspark.com   
Contact: Sharon Bond    +44 (01234) 835000    sharon.bond@spdspark.com   
Principal Investigator: Pauline A Parsons         
Sponsors and Collaborators
SPD Development Company Limited
Investigators
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Study Director: Sarah Johnson SPD Development company Ltd.
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Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT04010682    
Other Study ID Numbers: PROTOCOL-1095
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No