Abortion, CompleteNCT04217200
Pregnancy Dating Test - The Fall of hPL in Urine Over Time
An observational study of Abortion, Complete and Miscarriage Threatening, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women only
- Conditions the study is for
- Abortion, Complete, Miscarriage Threatening
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2020to 26 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with a singleton pregnancy presenting for a Caesarean section delivery
Who may be able to join
- The women is 18 years of age or older
- She understands the patient information leaflet, trial requirements and has signed the consent form
- The Caesarean delivery will be at GSTFT
- Prepared for urine to be collected for up to when the urinary catheter is removed or six hours, whichever is sooner
- Agrees for the demographic and medical history data to be collected.
Who cannot join
- Under 18 years of age
- Unable to understand the patient information leaflet or consent to join the trial
- The Caesarean delivery will not be at GSTFT
- The women is not for urine to be collected
- The women does not agree for demographic or history data to be collected.
- The women has a haemorrhage greater than one litre during the Caesarean delivery
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's & St Thomas' NHS Foundation Trust
London, England, SE1 7AB
About this study
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.
Read the 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:
- Invited to participate in study and given Patient Information Leaflet
- Informed consent obtained
- Eligibility for inclusion determined
- A urine sample (20ml) will be collected prior to the Caesarean from the urinary catheter
- Then urine samples (20mls) will be collected every 30 minutes for the first six hours following Caesarean section delivery
- The result of the dating ultrasound scan will be added to the trial documentation record
- 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.
- Conditions
- Abortion, Complete, Miscarriage Threatening
- Medical subject headings
- Abortion, Threatened
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of change in human placental lactogen concentration in urine post delivery by Caesarian section
Measured: Baseline and then 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330 & 360 minutes after delivery of the baby by Caesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start19 Feb 2020
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abortion, CompleteStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Anatole S Menon-Johansson, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Anatole S Menon-Johansson, PhD,MPH,FRCP, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217200
- Sponsor's protocol ID
- IRAS 198143
- Status last verified
- Jun 2020
- First submitted
- 16 Aug 2018
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Whittaker PG, Lind T, Lawson JY. A prospective study to compare serum human placental lactogen and menstrual dates for determining gestational age. Am J Obstet Gynecol. 1987 Jan;156(1):178-82. doi: 10.1016/0002-9378(87)90233-x.
PubMed 3541617
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Dating Test - The Fall of hPL in Urine Over Time
- ClinicalTrials.gov ID
- NCT04217200
- Acronym / sponsor ID
- IRAS 198143
- Conditions
- Abortion, Complete, Miscarriage Threatening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Invited to participate in study and given Patient Information Leaflet
- Informed consent obtained
- Eligibility for inclusion determined
- A urine sample (20ml) will be collected prior to the Caesarean from the urinary catheter
- Then urine samples (20mls) will be collected every 30 minutes for the first six hours following Caesarean section delivery
- The result of the dating ultrasound scan will be added to the trial documentation record
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with a singleton pregnancy presenting for a Caesarean section delivery
Key inclusion criteria (5 listed)
- The women is 18 years of age or older
- She understands the patient information leaflet, trial requirements and has signed the consent form
- The Caesarean delivery will be at GSTFT
- Prepared for urine to be collected for up to when the urinary catheter is removed or six hours, whichever is sooner
- Agrees for the demographic and medical history data to be collected.
Key exclusion criteria (6 listed)
- Under 18 years of age
- Unable to understand the patient information leaflet or consent to join the trial
- The Caesarean delivery will not be at GSTFT
- The women is not for urine to be collected
- The women does not agree for demographic or history data to be collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Results publication: PubMed 3541617Whittaker PG, Lind T, Lawson JY. A prospective study to compare serum human placental lactogen and menstrual dates for determining gestational age. Am J Obstet Gynecol. 1987 Jan;156(1):178-82. doi: 10.1016/0002-9378(87)90233-x.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatole S Menon-Johansson, PhD,MPH,FRCP principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion, Complete and Miscarriage Threatening, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.