Pregnancy Dating Test - The Fall of hPL in Urine Over Time

June 19, 2020 updated by: Anatole S Menon-Johansson, Guy's and St Thomas' NHS Foundation Trust

Earlier studies describe the half-life of hPL in serum as being ninety minutes and that the hormone is excreted unchanged in urine; consequently, there is real potential to use the fall in hormone levels in urine to monitor bleeding in pregnancy, the outcome of natural and artificial abortions or placental health.

This study will focus on the fall of hPL following delivery by Caesarean section when women have a urinary catheter in place and sampling urine is simple to achieve.

Study Overview

Status

Completed

Conditions

Detailed Description

The hormone hPL has a 90 minute half life in serum and the consequently since it is excreted unchanged in the urine it could be a useful marker to evaluate bleeding in pregnancy, determine if a pregnancy has ended by natural and artificial abortion or if there has been a change in placental function during a normal pregnancy.

The project will recruit twelve pregnant women having an elective Caesarean section to determine the fall in hPL over time. Urine samples will be taken just prior to and then every 30 minutes for the first six hours after delivery by Caesarean section.

Pregnant women presenting for an elective Caesarean section at Guy's & St Thomas' NHS Foundation Trust (GSTFT) will be approached to join this study and the following will be done:

  1. Invited to participate in study and given Patient Information Leaflet
  2. Informed consent obtained
  3. Eligibility for inclusion determined
  4. A urine sample (20ml) will be collected prior to the Caesarean from the urinary catheter
  5. Then urine samples (20mls) will be collected every 30 minutes for the first six hours following Caesarean section delivery
  6. The result of the dating ultrasound scan will be added to the trial documentation record
  7. The weight of the baby will be added to the trial documentation record

Consent The patient information leaflet clearly states the purpose of the research and the low risk of participation. The co-signing researcher on the consent form will ensure that the signee understands the alternative, is able to retain the relevant information, has capacity and is exercising free choice.

Risks, burdens and benefits This trial involves the collection of serial urine samples. The clinical history and result of the dating ultrasound scan will be recorded to estimate the gestation at delivery. The analysis of these samples will have no bearing on their clinical care.

Confidentiality All women recruited to the trial will be given a unique trial number. The trial data sheet will have the following information. The trial site, unique trial number, date of birth, date, estimated gestation from the result from the dating ultrasound scan. The samples collected will have the following information recorded: the unique trial number, date of birth, date and trial site code.

Conflict of interest None has been identified.

Use of tissue samples in future research The samples will not be stored.

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 7AB
        • Guy's & St Thomas' NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 52 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with a singleton pregnancy presenting for a Caesarean section delivery

Description

Inclusion Criteria:

  1. The women is 18 years of age or older
  2. She understands the patient information leaflet, trial requirements and has signed the consent form
  3. The Caesarean delivery will be at GSTFT
  4. Prepared for urine to be collected for up to when the urinary catheter is removed or six hours, whichever is sooner
  5. Agrees for the demographic and medical history data to be collected.

Exclusion Criteria:

  1. Under 18 years of age
  2. Unable to understand the patient information leaflet or consent to join the trial
  3. The Caesarean delivery will not be at GSTFT
  4. The women is not for urine to be collected
  5. The women does not agree for demographic or history data to be collected.
  6. The women has a haemorrhage greater than one litre during the Caesarean delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of change in human placental lactogen concentration in urine post delivery by Caesarian section
Time Frame: Baseline and then 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 & 360 minutes after delivery of the baby by Caesarean section
Baseline and then 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 & 360 minutes after delivery of the baby by Caesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College Hospital NHS Trust

Investigators

  • Principal Investigator: Anatole S Menon-Johansson, PhD,MPH,FRCP, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 19, 2020

Primary Completion (ACTUAL)

March 26, 2020

Study Completion (ACTUAL)

March 26, 2020

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

January 2, 2020

First Posted (ACTUAL)

January 3, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 198143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All samples will be labelled with a trial identifier when they are sent to the laboratory for analysis. Only the PI will know the link between the trial identifier and the patient clinic number. The patient clinic number can only be linked to an identifiable patient by staff who have access to the hospital electronic patient record.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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