Progesterone Audit

1
Progesterone Audit

• Shilpa Joshi
• SpR Chemical Pathology
• Royal Devon and Exeter NHS Foundation Trust

2
Background

• It was noticed by the staff in Clinical Chemistry
  at Royal Devon and Exeter Foundation
• Trust, that there was increase in serum
  progesterone requests over the last couple of
  years
• Many had either very little or no clinical
  details provided

3

• At around the same time, The Royal College of
  Pathologists published in their July 2011
• Bulletin
• Audit of progesterone requesting in
  pregnancy of unknown location, June 2009 carried
  out at Kingston Hospital NHS Trust

4

• That audit evaluated the nature of requests for
  progesterone (apart from fertility invsg.)
• They developed local guidance for requesting
  progesterone in PUL, wherein progesterone
• was only needed where serum ß-HCG was not
  declining as expected

• They developed a software rule to block requests
  from in- patient admissions/ AE ,
• which did not have a ß-HCG request on the
  same patients in the past 20 days

5

• A re audit by the same department in February
  2011 (published in the same bulletin) showed a
  remarkable reduction of 93 in serum progesterone
  tests being analysed
• They demonstrated an annual cost saving of 830
  on progesterone
• As a result we decided to audit our local
  progesterone requesting pattern

6
Local RDE protocol for management of PUL

• Progesterone (nmol/L) ß-HCG (IU/L)
• lt16 gt25
  Spontaneous resolving
  pregnancy, check ß-
• 
  HCG in 7 days
• 16-60 gt25
  Miscarriage/Ectopic with
  moderate
• 
  intervention,
  ß-HCG in 2 days.
• gt60
  lt1000 Normal intrauterine
  pregnancy, repeat
• 
  scan ß-HCG gt1000
• gt60 gt1000
  Ectopic pregnancy with
  high risk requiring
• 
  intervention,
  scan same day

7
Role of placenta and progesterone in early
pregnancy

• Corpus Luteum (Ovaries)
• secrete
• Progesterone
• maintains foetal viability
• Foetus
  Placenta signal

8
Aim

• To examine and compare serum progesterone
  requests received by the Department of Clinical
  Chemistry, RDE, in months February and March in
  the years 2008 and 2011
• To be in a position to draft and publish some
  local guidelines for requesting serum
  progesterone.

9
Method

• Encore data extraction software was used to
  obtain serum progesterone requests in the
• months Feb-March in the years 2008 and
  2011
• Only those progesterones which had an
  accompanying ß-HCG were included in the
• audit ( serum progesterones requested for
  investigation/ monitoring of infertility were not
  included)

10
Number of progesterones requested in two months
in 2008 and 2011
11

• In 2008
• 68X168
• 13X226
• 2X3 6
• 83 women 100 requests in 2 months
• In 2011
• 139X1139
• 15X230
• 2X36
• 156 women 175 requests in 2 months
• (A progesterone was erroneously added to a
  male patients test profile by the laboratory
  which was not included in the current audit)

12
Distribution of progesterone requests in (
83156) females according to age groups in
Feb-March 2008 2011

• The women ranged from ages 16-46 years in 2008
  and 15-44 years in 2011.

13
Requests in 2008 and 2011 stratified according to
departments
14
AE requests in 2008 2011
15
Clinical reasons for requesting serum
progesterone in 83 women in Feb-March 2008 and
156 women in Feb-Mar 2011
  Feb-Mar 2008 (Total83) Feb-Mar 2011(Total156)
MONITORING TREATMENT IN INFERTILITY 12 5
? ECTOPIC ? MISCARRIAGE 3 (3.6) 11 (7)
?ECTOPIC INCLUDING ABDOMINAL PAIN IN PREGNANCY 36 (43.3) 45 (28.8)
ECTOPIC 3 3
? MISCARRIAGE /PV BLEEDING IN PREGNANCY 15 (18) 47 (30.1)
MISCARRIAGE 0 2
THREATENED MISCARRIAGE 0 3
INCONCLUSIVE SCAN IN PREGNANCY 5 11
ABDO PAIN OTHERWISE 0 2
MOLAR PREGNANCY DIAGNOSED 1 1
PV BLEEDING OTHERWISE 1 0
RETAINED PRODUCTS 0 (0) 8 (5)
?PREGNANT/ PREGNANT 0 6
NCD 7 12
16
Clinical scenarios where the local RDE protocol
for management of PULcan be applied
2008 (44) 2011 (67)
? ECTOPIC ? MISCARRIAGE 3 11
?ECTOPIC INCLUDING ABDOMINAL PAIN IN 36 45
PREGNANCY 36 45
INCONCLUSIVE SCAN IN PREGNANCY 5 11
17
Classification of the above cases according to
the local RDE protocol for management of PUL

• ?Ectopic / PUL
  in 2008/ 2011
  
  33 cases (2008) 52 cases
  (2011) had a single progesterone
• 
  
  11cases (2008) 15 cases (2011) had more than
  one progesterone
• 
  
  Baseline progesterone ß-HCG
• 
  
  
• Prog. ß-HCG
  
  
  Prog.
  ß-HCG
• lt16 gt25 Spont.
  resolving pregnancy, ß- HCG in 7 days
  
  16-60 gt25
  Miscarriage/Ectopic with moderate
• 
  
  
  
  intervention,
  ß-HCG in 2 days.
• 6 (2008) 3 (2011)
• 
  
  
  4
  (2008) 8 (2011)
• 
  
  
  

18

• Progesterone (nmol/L) ß-HCG (IU/L)
• lt16 gt25
  Spontaneous resolving
  pregnancy, check ß-
• 
  HCG in 7 days
• 6 cases (2008) of which
  4 women miscarried, 2 had decreasing ß-
• 
  HCG with unknown
  outcomes
• 3 cases (2011) of which
  1 woman was diagnosed with ectopic, 2
  
• 
  had decreasing
  ß-HCG with unknown
• 
  outcomes
• 
  

19

• Progesterone (nmol/L) ß-HCG (IU/L)
• 16-60 gt25
  Miscarriage/Ectopic with
  moderate
• 
  intervention, ß-HCG
  in 2 days
• 4 cases (2008) of which
  2 women went to full term, 2 had decreasing ß-
• 
  HCG with unknown
  outcomes
• 8 cases (2011) of which
  2 women went to full term, 1 had ectopic, 2
• 
  miscarried, 3 had
  decreasing ß-HCG with
• 
  unknown outcomes

20

• Progesterone (nmol/L) ß-HCG (IU/L)
• gt60
  lt1000 Normal intrauterine
  pregnancy, repeat scan
• 
  ß-HCG gt1000
• 1 case (2011)
  ß-HCG not doubling, Ectopic

21

• Progesterone (nmol/L) ß-HCG (IU/L)
• gt60
  gt1000 Ectopic pregnancy with
  high risk requiring
• 
  intervention, scan
  same day
• 1 case (2008) which
  went on to have a full term pregnancy
• 3 cases (2011) of which
  1 had full term pregnancy, whilst the
• 
  other 2 miscarried,
• 
  

22
Clinical reasons (excluding investigation for
infertility/ threatened miscarriage) for
analysing progesterones, which do not fulfil the
local PUL algorithm
  Feb-Mar 2008 (Total 27 ) Feb-Mar 2011(Total 81)
ECTOPIC 3 3
? MISCARRIAGE /PV BLEEDING IN PREGNANCY 15 47
MISCARRIAGE 0 2
ABDO PAIN OTHERWISE 0 2
MOLAR PREGNANCY DIAGNOSED 1 1
PV BLEEDING OTHERWISE 1 0
RETAINED PRODUCTS 0 8
?PREGNANT/ PREGNANT 0 6
NCD 7 12
23
Conclusions 2008/2011

• The audit evaluated a total of 100 serum
  progesterone tests in Feb-March 2008 and 175
• in Feb-March 2011
• 239 different patients in months of Feb-March
  2008 2011 had a total of 275
• progesterone tests

24

• There was increase in progesterone requests by
  75 in 2011 compared to 2008
• The major requestor was OBGYN 83/100 (83) in
  2008 and 134/ 175 (76.5) in 2011
• The main reasons for requesting the test was ?
  Ectopic pregnancy and ? Miscarriage / PV bleeding
  in pregnancy

25

• Perhaps the algorithm for PUL is being utilised
  indiscriminately in other clinical
• scenarios, 32.5 (2008) , 51.9 (2011)
• In 2008, 10 cases (4 OBGYN5 GP1 UNK) had a
  progesterone requested even though
• the baseline ß-HCG lt1. Out these 7 cases
  were for querying ectopic pregnancy
• In 2011, 21 cases ( 8GP 2AE 11 OBGYN ) had
  a serum progesterone even though
• baseline ß-HCG demonstrated that the
  patients were not pregnant
• AE continues to order baseline ß-HCG
  Progesterone in high proportions

26
Limitations of the audit

• It was tricky to evaluate the suitability of the
  test requests exclusively on the basis of
• the clinical details available on PTH,
  which were often insufficient
• The level of seniority of medical staff
  requesting progesterones could not be verified ,
  as
• samples were booked under the consultant
  leading the team

27

• Request forms from AE have AE consultant names
  printed on the forms, therefore,
• samples from AE may have been requested
  by other departments
• Also, in cases where progesterone/ ß-HCG added
  at a later time, it was difficult to know
• the team requesting these tests as
  samples were booked under AE
• Currently there is no clear guidance regarding
  the clinical conditions meriting a serum
• progesterone

28
Recommendations

• Liaise with OBGYN to encourage use of the PUL
  algorithm only in those conditions
• which fit the criteria, and,
  discourage use in other clinical scenarios
• Serum progesterone to be not analysed in
  situations where no clinical/ irrelevant
• clinical details provided
• Re audit data probably in a year

29
References

• The management of early pregnancy loss (green-top
  guideline no.25, October 2006) Royal College of
  Obstetricians and Gynaecologist
• Audit of progesterone requesting in pregnancy of
  unknown location, June 2009 The Royal College of
  Pathologist Bulletin, July 2011, pg 200-203
• Expectant management of ectopic pregnancy
  (revised Feb2010), Guidelines by Child and
  Womens Health, Royal Devon and Exeter NHS Trust
• Donna Day Baird, Clarice R. Weinberg, D. Robert
  McConnaughey, and Allen J. Wilcox Rescue of the
  Corpus Luteum in Human Pregnancy Biol Reprod
  February 2003 68 (2) 448-456

30
Acknowledgement

• Dr OConnor/ Dr Salzmann

31

• Thank you