Late Pregnancy Sample Collection Study

Completed

• Conditions: Pregnancy

• Registration Number: NCT04010682
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-06-19
• Study Start: 2019-06-20
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
late pregnancy urine samples	4 weeks	Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

SPD Development Company Ltd; 🇬🇧 Bedford, Bedfordshire, United Kingdom