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

NCT04217200 | Completed

• 1 other identifier: IRAS 198143
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Abortion, Complete; Miscarriage Threatening

Outcome Measures

Primary Outcomes (1)

• The rate of change in human placental lactogen concentration in urine post delivery by Caesarian 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

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College Hospital NHS Trust: collaborator

Study Sites (1)

Guy's & St Thomas' NHS Foundation Trust

London, England, SE1 7AB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 3541617 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Abortion, Threatened

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anatole S Menon-Johansson, PhD,MPH,FRCP

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Clinical Lead, Sexual & Reproductive Health Department

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: January 3, 2020
• Study Start: February 19, 2020
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)