An observational study in Abortion, Complete and Miscarriage Threatening, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 52 Years. Per ClinicalTrials.gov, last updated 2020-06-22.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
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:
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.
320 studies on the registry are indexed under Abortion, Spontaneous; 53 are open to participants now.
This study's enrollment of 11 is below the median of 200 across 140 observational studies indexed under Abortion, Spontaneous.
Browse Abortion, Spontaneous studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women with a singleton pregnancy presenting for a Caesarean section delivery
Exclusion Criteria:
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
Plan to share: 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.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust