Clinical Details Form

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2
Screening number
Initials
Day
0
Month
1
Year
DEMOGRAPHIC DETAILS
A
Age
If not aged between 16 and 45 patient is ineligible
White
Mixed –
white &
Asian
Black Caribbean
Mixed – white &
black Caribbean
Asian Bangladeshi
Asian - Indian
Mixed – other
Mixed – white &
black African
Asian - other
Asian Pakistani
Chinese
Black African
Black - other
Other ethnic group
Not stated
If other ethnic group
please specify
Do you currently
smoke?
Have you ever
smoked?
Yes
No
How many per day?
Yes
No
If yes, Date stopped?
_DD / MMM / YYYY
CLINICAL OBSERVATIONS
Height (cm)
Weight (kgs)
BMI
BP (mm/Hg)
RELEVANT MEDICAL HISTORY (please include dates)
Medical History
Date
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
CONCOMITANT MEDICATIONS
Current Medications (regular over last 3 months)
Name
Dose
Frequency
Yes
No
Start Date
Stop Date
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
_DD / MMM / YYYY
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PRE-EMPT study Clinical details screening CRF Version 1.0 13th March 2014 13/NS/0103
Indication
2
Screening number
Initials
Day
Month
0
1
Year
CONCOMITANT
MEDICATIONS
GYNAECOLOGICAL
HISTORY
Parity
+
Date of last menstrual cycle
Comments
_DD / MMM / 2 0 YY_
Previous treatments (prior to current laparoscopy)
(give relevant advice according to treatment allocated)
Please 
Reason for treatment
CPP (chronic pelvic pain)
LNG-IUS
Yes
Post op prevention
No
Contraception
Heavy menstrual bleeding
CPP (chronic pelvic pain)
DMPA
Yes
Post op prevention
No
Contraception
Heavy menstrual bleeding
CPP (chronic pelvic pain)
COCP
Yes
Post op prevention
No
Contraception
Heavy menstrual bleeding
If other reason:
Previous GnRha
Yes
No
Which type?
Previous HRT
Yes
No
Which type?
Previous laparoscopy
Yes
No
Date
_DD / MMM / 2 0 YY_
Previous laparoscopy
Yes
No
Date
_DD / MMM / 2 0 YY_
Previous laparoscopy
Yes
No
Date
_DD / MMM / 2 0 YY_
Pregnancy test
Yes
No
Positive
Negative
Date
Chlamydia test result
Yes
No
Positive
Negative
Date
_DD / MMM / 2 0 YY_
_DD / MMM / 2 0 YY_
If pregnancy positive patient is ineligible. If Chlamydia positive – do not insert IUS until treated
SCREENING ELIGIBILITY
Patient fulfils screening criteria?
Yes
No
Consent form signed?
Yes
No
Baseline questionnaire completed and signed?
Yes
No
CONTINUE WITH FORM AT TIME OF SURGERY
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PRE-EMPT study Clinical details screening CRF Version 1.0 13th March 2014 13/NS/0103
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Screening number
Initials
Day
0
Month
1
Year
SURGERY DETAILS
Name of surgeon
Date of surgery
_DD / MMM / 2 0 YY_
Type of Surgery (please tick)
Diagnostic/Therapeutic (2 stage)
See & Treat
Extent of excision (Opinion of Surgeon)
Complete
Incomplete
i
(minimal)
ii
(mild)
Were digital images of endometrial lesions
captured during Laparoscopy
Yes
No
Ovarian Endometriosis present
Yes
No
AFS Stage of Endometriosis
iii
(moderate)
iv
(severe)
Please enter 4 digit
Randomisation number
SIGNATURE OF CLINICIAN
_DD / MMM / 2 0 YY_
Clinician’s Signature
Date
COMPLIANCE WITH TREATMENT ALLOCATION
Day of menstrual cycle (give relevant advice according to treatment allocated)
TREATMENT COMPLICATIONS (If ‘yes’, please complete an AE form to determine if the complication is deemed
Treatment
Please

How was this administered / prescribed?
Please 
Reason
serious
toallocated
report as
an SAE)
During Surgery
TES
Before discharge
SIGNATURE
LNG-IUS
Referred to GP/Sexual Health Clinic
Failure to fit
Declined (please state reason)
During Surgery
Before discharge
DMPA
Referred to GP/Sexual Health Clinic
Failure to administer
Declined (please state reason)
First cycle of tablets given to patient
Prescription dispensed in hospital
COCP
Referred to GP/Sexual Health Clinic
Declined (please state reason)
SURGICAL COMPLICATIONS (If ‘yes’, please complete an AE form to determine if the complication is
deemed serious to report as an SAE)
Any complications
Yes
No
If ‘yes’ please select from list below
Vaso-vagal episode
Cervical trauma
Uterine perforation
Haemorrhage
If Other: specify
SIGNATURE
Form completed by (please print)
Signed
Date form completed
_DD / MMM / YYYY
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PRE-EMPT study Clinical details screening CRF Version 1.0 13th March 2014 13/NS/0103
2
Screening number
Initials
Day
Month
0
1
Year
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PRE-EMPT study Clinical details screening CRF Version 1.0 13th March 2014 13/NS/0103
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