Late Pregnancy Sample Collection 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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development Company Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

healthy pregnant volunteers

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late pregnancy urine samples	Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy complications	Number of participants reporting pregnancy complications from week 36 of pregnancy until birth	6 weeks
Live birth	number of study participants who's pregnancy resulted in a live birth	6 weeks
Spontaneous vaginal delivery	number of study participants who's pregnancy resulted in a spontaneous vaginal delivery	6 weeks
weight of baby	weight of baby in pounds and ounces or kilograms	6 weeks
multiple births	number of pregnancies resulting in single baby, twins or triplets.	6 weeks

Collaborators and Investigators

• Sponsor: SPD Development Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Actual): April 23, 2020
• Study Completion (Actual): April 23, 2020

Study Registration Dates

• First Submitted: June 19, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-1095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No