Late Pregnancy Sample Collection Study

Pregnancy Clinical Trial

Official title:

Late Pregnancy Sample Collection Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04010682
• Other study ID #: PROTOCOL-1095
• Status: Completed
• Start date: June 20, 2019
• Est. completion date: April 23, 2020

Study information

• Verified date: May 2022
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 23, 2020
• Est. primary completion date: April 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late pregnancy urine samples	Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.	4 weeks
Secondary	pregnancy complications	Number of participants reporting pregnancy complications from week 36 of pregnancy until birth	6 weeks
Secondary	Live birth	number of study participants who's pregnancy resulted in a live birth	6 weeks
Secondary	Spontaneous vaginal delivery	number of study participants who's pregnancy resulted in a spontaneous vaginal delivery	6 weeks
Secondary	weight of baby	weight of baby in pounds and ounces or kilograms	6 weeks
Secondary	multiple births	number of pregnancies resulting in single baby, twins or triplets.	6 weeks