Abortion, Complete Clinical Trial
Official title:
Pregnancy Dating Test - The Fall of hPL in Urine Over Time
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.
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.
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