Rare diseases and rare complications of pregnancy

College Moeder Kind 1

Rare diseases and rare complications of pregnancy

Pulmonary embolism

Antenatal Pulmonary Embolism

DATA COLLECTION FORM

Hospital name

Hospital case number

(gelieve hier een dossiernummer of andere code in te vullen, waardoor u in staat bent het dossier van deze casus makkelijk te traceren op een later tijdstip)

B.OSS: Pulmonary embolism College Moeder & Kind

BACKGROUND INFORMATION



Pulmonary embolism

Pulmonary embolism (PE) is a leading cause of maternal death, demonstrated in the 7th report of Confidential Enquiries into maternal deaths in the United Kingdom (2007), and other comparable reports of Norway, Australia, United States. An overview of maternal deaths in SPE (Studiecentrum voor Perinatale Epidemiologie) reported 92 maternal deaths since onset of SPE-registration, of which 12 cases were caused by pulmonary embolism, being the second most frequent cause.

UKOSS has studied Antenatal Pulmonary Embolism in a case-control study: between

February 2005 and August 2006 they identified 143 cases, representing an incidence of

1.3 per 10.000 maternities (95% 1.1-1.5). UK has comprehensive guidelines on both prevention and management of venous thromboembolism in pregnancy (RCOG green top guideline No 37 a and No 37 b). Some of the cases identified were the consequence of suboptimal implementation of the national guidelines for the prevention of thrombosis during pregnancy. However, the majority of the cases (94%) were not eligible for thromboprophylaxis according to the current guidelines. Multiparity and obesity were the main riskfactors, but even this large cohort study had insufficient power to show statistically significant associations with other riskfactors. This highlights the need for very large, multinational studies of rare conditions to accurately identify and quantify significant risks. Antenatal pulmonary embolism is or has been studied by other Obstetric

Surveillance Systems: AMOSS (Australia – New Zealand), AuOSS (Austria), France

(EPIMOMS), GerOSS (Germany).

In Belgium we are currently unaware of the incidence of antenatal pulmonary embolism, how antenatal PE is diagnosed, how we manage antenatal PE and what the outcomes are for both mother and child.

A nationwide study of antenatal PE during 4 years by B.OSS can provide more insight in this rare but possible life-threatening disorder of pregnancy in Belgium. Furthermore this study can contribute to an international study as part of the INOSS (the International

Network of Obstetric Survey Systems).

Research questions:

1.

What is the incidence of antenatal pulmonary embolism in Belgium?

2.

How is antenatal pulmonary embolism managed in Belgium? (What guidelines do we use?)

3.

What is the outcome of antenatal pulmonary embolism in Belgium for mother and child?


Definition pulmonary embolism



Pulmonary embolism

B.OSS will use the same definition as used by UKOSS, to enable comparison and participation in international studies.

– EITHER

PE is confirmed using suitable imaging (angiography, computed tomography, echocardiography, magnetic resonance imaging or ventilation-perfusion scan showing a high probability of PE)

– OR PE is confirmed at surgery or postmortem

– OR a clinician has made a diagnosis of PE with signs and symptoms consistent with PE present, and the patient has received a course of anticoagulation therapy (>1 week duration)




Pulmonary embolism

Instructions

U kunt deze vragenlijst (na downloaden en opslaan) elektronisch invullen, vervolgens opslaan en doormailen naar B.OSSVlaanderen@gmail.com

.

Aarzel niet ons te contacteren indien u hierbij problemen zou ondervinden.

Gelieve geen persoonlijke identificeerbare informatie in te vullen (zoals naam, adres enzovoort).

Gelieve bij het aanmelden op het rapporteringsformulier en onder ‘’Hospital Case number’’ op de voorpagina van deze vragenlijst, een dossiernummer of andere code in te vullen, waardoor u in staat bent het dossier van deze casus makkelijk te traceren bij verdere communicatie over de vragenlijst, bvb. wanneer op een later tijdstip bijkomende informatie zou opgevraagd worden.

Vink de hokjes aan , aan de hand van het dossier. Wil er op letten niet zowel “yes” en”no” op dezelfde vraag te antwoorden.

Indien er te weinig plaats voorzien is bij een vraag kan u verder aanvullen in sectie 7.

Indien een vraag niet beantwoord kan worden, gelieve dit te vermelden in sectie 7.

Data worden genoteerd als yyyy/mm/dd en voor tijden wordt de 24-uurs notatie gebruikt (bvb 18:37).

Bij een aantal vragen wordt een indicatieve lijst (niet-limitatief) opgegeven, deze vindt u terug achterin deze vragenlijst.

Indien de patiënte nog niet is bevallen op het moment van het invullen van deze vragenlijst, gelieve dan zo volledig mogelijk in te vullen wat u reeds weet en de vragenlijst terug te sturen. U kunt ons de verdere gegevens over bevalling, uitkomst moeder en uitkomst kind doorsturen na de bevalling. We zullen u hiervoor contacteren om u hieraan te helpen herinneren.

Aarzel in geen geval ons te contacteren bij vragen of problemen op b.ossvlaanderen@gmail.com

.




Pulmonary embolism

Name of person completing the form

(yyyy/mm/dd) Date of completing the form

Section 1: Woman’s details

1.1 Year of birth (yyyy)

1.2 Ethnic group woman

White (European, Middle-East, North-African, White South-African)

Black (African, Caribean, Afro-American)

Asian (Indian, Pakistan, Bangladesh

South-East Asian (Japanese, Chinese, Vietnamese)

Mixed

Unknown

Other, please specify

1.3 Marital status

Single

Married

Cohabiting

Not registered in the case notes

1.4 Employment

Yes No Not registered in the case notes

If Yes, what is her occupation:

If No, what is her partner’s (if any) occupation:

1.5 Height at booking (cm)

1.6 Weight at booking (kg)


1.7 Smoking status

Never

Current

Gave up prior to pregnancy



Pulmonary embolism

Gave up during pregnancy


Section 2: Previous pregnancies

2.1 Gravidity excluding the present pregnancy

Number of completed pregnancies beyond 22 weeks

Number of pregnancies less than 22 weeks

If no previous pregnancies, please go to section 3

2.2 Did the woman have any previous pregnancy problems?


If yes, please specify (non-exhaustive list number 1)

Section 3: Previous Medical History

3.1 Previous or pre-existing medical problems






Pulmonary embolism

3.2 Did the woman have gross varicose veins?


3.3 Did the woman have previous surgery for varicose veins?


3.4 Is there a history of thrombosis in first degree relatives?


3.5 Did the woman have a known thrombophilia?

Not registered in the case notes Yes No

If yes, please specify (list number 3)

Section 4: Past history of thrombosis

4. Did the woman have a past history of thrombosis (either in previous pregnancies or when not pregnant)

Yes No

If no, please go to section 5


4.1 Number of thrombotic events

4.2.a. Details of the first thrombotic event

Date of occurrence (yyyy/mm/dd)

Site :

(e.g. DVT/PE/axillary thrombosis/cerebral thrombosis…) :

Occurred during/following (please tick all that apply)

Pregnancy

Puerperium

Surgery




Pulmonary embolism

Combined oral contracteptive pill (oestrogen + progesterone)

Fracture/trauma


4.2.b. Details of the second thrombotic event

Date of occurrence (yyyy/mm/dd)

Site :

(e.g. DVT/PE/axillary thrombosis/cerebral thrombosis…) :

Occurred during/following (please tick all that apply)

Pregnancy

Puerperium

Surgery

Combined oral contracteptive pill (oestrogen + progesterone)

Fracture/trauma


If more than two events, please add details in section 7

Section 5a: This pregnancy

(yyyy/mm/dd) 5a.1 Final estimated date of delivery (EDD)

5a.2 Way of conception

Spontaneously

Assisted reproductive therapy


5a.2 Was this pregnancy a multiple pregnancy?

Yes No

If Yes, please specify number of foetuses




Pulmonary embolism

5a.3 Were there problems in this pregnancy?



5a.4 History of long haul travel during this pregnancy


If yes, please specify duration ( hours ) and date

5a.5 Period of immobility/bed rest during this pregnancy

Yes No

(yyyy/mm/dd)


If yes, please specify duration of immobility ( days ) and date of first day of immobility (yyyy/mm/dd).

5a.6 Was thromboPROPHYLAXIS used?

Yes No

If yes, which guideline has been consulted


(e.g. RCOG greentop guideline, the Belgian Thrombosis Guidelines Group, local guideline, haematologists advice, other)

If yes, please indicate below all measures used (please tick all that apply)

TED stockings

Antiplatelet agent (e.g.aspirin)

Name of drug

Dose

Schedule (times per day)

Low molecular weight heparin (e.g. Fragmin, Clexane, Fraxiparine, Fraxodi, Innohep)

Name of drug

Dose





Pulmonary embolism

Unfractionated Heparin

Name of drug

Dose

Schedule

Coumarin Derivates

Name of drug

Dose


What was the date of the last INR before the PE?

What was this INR?

Other

Name of drug

Dose


(yyyy/mm/dd)

5a.7 Did this woman have a thrombotic event (e.g. DVT) in this pregnancy prior to her

PE?


If yes, specify date (yyyy/mm/dd)

If Yes, please specify anticoagulant treatment


Name of drug

Dose



Name of drug

Dose

Schedule

Coumarin Derivates

Name of drug

Dose


Other




Pulmonary embolism

Name of drug

Dose


If more than one event, please add details in section 7

Section 5b: Diagnosis of PE

5b.1 Date of PE (yyyy/mm/dd)

5b.2 Site of PE (e.g. left/right/basal/apical)

5b.3 Did the woman have symptoms and signs consistent with PE?


If yes, please briefly describe the findings?

5b.4 Which tests were used to confirm the diagnosis? (please tick all that apply)

Arterial blood gas

Date (yyyy/mm/dd)

Did the result support the diagnosis?

Yes No

D-dimer levels

Date (yyyy/mm/dd)

What was the level?

Unit used (e.g. ng/ml)

Compression duplex ultrasonography

Date (yyyy/mm/dd)


Yes No

Chest X-ray




Pulmonary embolism

Date (yyyy/mm/dd)


Yes No

VQ scan

Date (yyyy/mm/dd)


Yes No

CT scan

Date (yyyy/mm/dd)


Yes No

Echocardiogram

Date (yyyy/mm/dd)


Yes No

MRI scan

Date (yyyy/mm/dd)


Yes No

CT pulmonary angiography

Date (yyyy/mm/dd)


Yes No

Section 5c: Therapy

5c.1 Was therapeutic anticoagulation used?

Yes No

If Yes, please specify drug(s) used


Name of drug

Dose






Pulmonary embolism

Name of drug

Dose

Schedule

Coumarin Derivates

Name of drug

Dose


Other

Name of drug

Dose


Did the therapy last for more than 7 days?


If yes, please indicate duration (eg. 3 months, 6 months, lifelong)

5c.2 Any other medication e.g. thrombolytic therapy

Yes No

If Yes, please specify name(s) of drugs used

5c.3 Surgical management

Yes No

If Yes, please specify type of surgery and operative findings




Pulmonary embolism

Section 6: Outcomes

Section 6a: Woman

6a.1 Is this woman still undelivered?

Yes No

If Yes, will she be receiving the rest of her antenatal care from the current hospital?

Yes No

If care will be provided at a different hospital, please indicate name of that hospital

Then go to section 7

If No, please continue

6a.2 Did this woman have a miscarriage?

Yes No

If Yes, please specify date (yyyy/mm/dd)

6a.3 Did this woman have a termination of pregnancy ?

Yes No

If Yes, please specify date (yyyy/mm/dd)

6a.4 Was delivery induced?

Yes No

If Yes, please state indication

6a.5 Did the woman labour?

Yes No

6a.6 Was delivery by caesarean section?

Yes No

If Yes, please state whether elective OR emergency

Give indication for caesarean section




Pulmonary embolism

6a.7 Was the woman admitted to an intensive care unit?

Yes No

If Yes, duration of stay ( days )

Please tick if the woman was transferred to another hospital?

Please indicate name of hospital

6a.8 Did any other major maternal morbidity occur?



6a.9 Was a thrombophilia diagnosed during or after this pregnancy?



6a.10 Did the woman die?

Yes No

If Yes, please specify date of death (yyyy/mm/dd)

What was the primary cause of death as stated on the death certificate

Was a post mortem examination undertaken?

Yes No

If Yes, did the examination confirm the diagnosis?

Yes No




Pulmonary embolism

Section 6b: Infant

Outcome infant 1

6b.1 Date of delivery

6b.2 Gestational age at delivery

(yyyy/mm/dd)

(weeks)

6b.3 Mode of delivery

Spontaneous vaginal delivery

Instrumental delivery (vacuum, forceps)

Pre-labour cesarean section

Caesarean section after onset of labour

6b.3 Birthweight (gram)

6b.4 Was the infant stillborn?

Yes No

If yes, go to section 7

6b.5 Please note the 5 min Apgar

6b.6 Was the infant admitted to a neonatal unit? (NICU, N*)

Yes No

If Yes, please tick what unit

NICU N*

If Yes, duration of stay ( days )

Was the infant transferred to another hospital?

Yes No

If Yes, please indicate name of hospital

(days)




Pulmonary embolism

6b.7 Did any major infant complications occur?



6b.8 Did this infant die ?

Yes No

If Yes, please specify date of death (yyyy/mm/dd)

What was the primary cause of death as stated on the death certificate

(please state if not known)

Section 7:

Please use this space to enter any other information you feel may be important




Pulmonary embolism

Indicative lists

1: Previous or current pregnancy problems, including

Recurrent miscarriages (3 or more)

Amniocentesis

Amniotic fluid embolism

Baby with a major congenital abnormality

Gestational diabetes

Haemorrhage

Hyperemesis requiring admission/ Dehydration

Infant requiring intensive care

Neonatal death

Ovarian hyperstimulation syndrome

Placenta praevia

Placental abruption

Post-partum haemorrhage requiring transfusion

Pre-eclampsia (hypertension and proteinuria)

Premature rupture of membranes

Partus prematurus

Partus immaturus

Puerperal psychosis

Severe infection e.g. pyelonephritis

Stillbirth

Surgical procedure in pregnancy


2: Previous or pre-existing maternal medical problems, including

Cardiac disease (congenital or acquired)

Diabetes

Epilepsy

Endocrine disorders e.g. hypo or hyperthyroidism

Essential hypertension

Haematological disorders e.g. sickle cell disease

Inflammatory disorders e.g. inflammatory bowel disease

I.V. drug use

Lung disease

Myeloproliferative disorders e.g.essential thrombocythaemia, polycythaemia vera

Neoplasia

Paraplegia

Psychiatric disorders

Renal disease e.g. nephrotic syndrome

Systemic lupus erythematosus





Pulmonary embolism

3: Thrombophilia, including

Congenital trombophilia

Activated protein C Resistance / Factor V Leiden Homozygote

Activated protein C Resistance / Factor V Leiden Heterozygote

Antithrombin deficientie (Factor III)

Protein C Deficiency

Protein S Deficiency

Prothrombin gene variant (20210 G>A Factor II)

Elevated Factor VIII

Hyperhomocysteinemia

Acquired trombophilia

Anticardiolipin antibodies

Lupus anticoagulant

Anti-beta-2glycoproteïne antibodies

4: Major maternal medical complications, including

Adult respiratory distress syndrome

Cardiac arrest

Cerebrovascular accident

Disseminated intravascular coagulopathy

HELLP

Haemorrhage requiring transfusion

Mendelson’s syndrome (chemical pneumonitis caused by aspiration during anaesthesia)

Persistent vegetative state

Renal failure

Required ventilation

Septicaemia


5: Infant complications, including :

Chronic lung disease

Exchange transfusion

Intraventricular haemorrhage

Jaundice requiring phototherapy

Major congenital anomaly

Necrotising enterocolitis

Neonatal encephalopathy

Respiratory distress syndrome

Severe infection e.g. septicaemia, meningitis



Rare diseases and rare complications of pregnancy

Antenatal Pulmonary Embolism

Hospital name

Hospital case number

Section 1: Woman’s details

Section 2: Previous pregnancies

Section 3: Previous Medical History

Section 4: Past history of thrombosis

Section 5a: This pregnancy

Section 5b: Diagnosis of PE

Section 5c: Therapy

Section 6: Outcomes

Section 6a: Woman

Section 6b: Infant

Section 7:

Indicative lists

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Rare diseases and rare complications of pregnancy

Antenatal Pulmonary Embolism

Hospital name

Hospital case number

Section 1: Woman’s details

Section 2: Previous pregnancies

Section 3: Previous Medical History

Section 4: Past history of thrombosis

Section 5a: This pregnancy

Section 5b: Diagnosis of PE

Section 5c: Therapy

Section 6: Outcomes

Section 6a: Woman

Section 6b: Infant

Section 7:

Indicative lists

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