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Completed

NCT Number: NCT04010682

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine sample collection

Other

no drug/devise intervention. sample collection study only

Primary outcomes

  1. late pregnancy urine samples

    Time frame: 4 weeks

    Number of volunteers providing daily urine samples from 36 weeks pregnant until birth.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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