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College Moeder KindRare diseases and rare complications of pregnancy

Pulmonary embolism

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Antenatal Pulmonary EmbolismDATA 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


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BACKGROUND INFORMATION

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?



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Definition 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)



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Instructions

- U kunt deze vragenlijst (na downloaden en opslaan) elektronisch invullen, vervolgens opslaan en doormailen naar [email protected].

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 [email protected].


mailto:[email protected]



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Instructions

- Vous pouvez compléter le formulaire et le renvoyer à: [email protected].

- Ne divulguer aucune information personnelle du patient qui pourrait être identifiable (comme le nom, adresse, etc…).

- Sur la première page de ce questionnaire à remplir, vous trouverez l’onglet ''Hospital case number'' qui est le numéro de dossier ou de code par rapport au cas à déclarer. Il est important de bien le notifier afin d’avoir une traçabilité au cas où nous aurions des informations supplémentaires à vous demander plus tard.

- Si vous n’avez pas assez de place pour compléter certaines questions, n’hésitez pas à le notifier dans la section 7.

- La section 7 est aussi l’endroit où vous pouvez noter les questions où vous n’avez pas de réponses.

- Les dates sont notifiées comme ceci (aaaa / mm / jj) avec le système horaire de 24h00 (ex : 18h30)

- Si la patiente n'a pas encore donné naissance au moment de compléter ce questionnaire, s'il vous plaît compléter le plus possible de ce que vous savez déjà et retourner le questionnaire.

- Vous pourrez nous envoyer des informations complémentaires sur l'accouchement par après. Au besoin, nous vous contacterons.

N’hésitez pas à nous contacter si vous avez d’autres questions via le mail suivant : [email protected].





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Name of person completing the form

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

Section 1: Woman’s details

1.1 Year of birth (yyyy)

1.2 Ethnic group woman

1.3 Marital status

1.4 Employment

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


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

Single

Married

Cohabiting

Not registered in the case notes

Yes No Not registered in the case notes


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Section 2: Previous pregnancies

2.1 Gravidity excluding the present pregnancyNumber 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



Never

Current

Gave up prior to pregnancyGave up during pregnancyNot registered in the case notes




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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?

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)

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


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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)

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

Section 5a: This pregnancy

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

5a.2 Way of conception

5a.2 Was this pregnancy a multiple pregnancy?

If Yes, please specify number of foetuses


Combined oral contracteptive pill (oestrogen + progesterone)Fracture/trauma


Pregnancy

Puerperium

SurgeryCombined oral contracteptive pill (oestrogen + progesterone)Fracture/trauma


Spontaneously

Assisted reproductive therapyNot registered in the case notes

Yes No


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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 (yyyy/mm/dd)

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

If yes, please specify duration of immobility (days)

and date of first day of immobility (yyyy/mm/dd).

5a.6 Was thromboPROPHYLAXIS used?

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)

Name of drug

Dose

Schedule (times per day)

Name of drug

Dose







TED stockings

Antiplatelet agent (e.g.aspirin)

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


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Name of drug

Dose

Schedule

Name of drug

Dose


What was the date of the last INR before the PE? (yyyy/mm/dd)

What was this INR?

Name of drug

Dose


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

Name of drug

Dose



Unfractionated Heparin

Coumarin Derivates

Other




Coumarin Derivates


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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)

Date (yyyy/mm/dd)Did the result support the diagnosis?

Date (yyyy/mm/dd)

What was the level?

Unit used (e.g. ng/ml)



Other


Arterial blood gas

Yes No

D-dimer levels

Compression duplex ultrasonography

Yes No


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Section 5c: Therapy

5c.1 Was therapeutic anticoagulation used?

If Yes, please specify drug(s) used

Name of drug

Dose



Chest X-ray

Yes No

VQ scan

Yes No

CT scan

Yes No

Echocardiogram

Yes No

MRI scan

Yes No

CT pulmonary angiography

Yes No

Yes No



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Name of drug

Dose

Schedule

Name of drug

Dose


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

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

5c.3 Surgical management

If Yes, please specify type of surgery

and operative findings



Coumarin Derivates

Other


Yes No

Yes No


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Section 6: OutcomesSection 6a: Woman

6a.1 Is this woman still undelivered?

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

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?

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

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

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

6a.4 Was delivery induced?

If Yes, please state indication

6a.5 Did the woman labour?

6a.6 Was delivery by caesarean section?

If Yes, please state whether

Give indication for caesarean section


Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

Yes No

elective OR emergency


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

If Yes, duration of stay (days)

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?

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?

If Yes, did the examination confirm the diagnosis?


Yes No

Please tick if the woman was transferred to another hospital?



Yes No

Yes No

Yes No


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Section 6b: Infant

Outcome infant 1

6b.1 Date of delivery (yyyy/mm/dd)

6b.2 Gestational age at delivery (weeks) (days)

6b.3 Mode of delivery

6b.3 Birthweight (gram)

6b.4 Was the infant stillborn?

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*)

If Yes, please tick what unit

If Yes, duration of stay (days)

Was the infant transferred to another hospital?

If Yes, please indicate name of hospital


Spontaneous vaginal delivery

Instrumental delivery (vacuum, forceps)

Pre-labour cesarean section

Caesarean section after onset of labour

Yes No

Yes No

NICU N*

Yes No


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6b.7 Did any major infant complications occur?


6b.8 Did this infant die?

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



Yes No


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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/ DehydrationInfant requiring intensive care Neonatal death Ovarian hyperstimulation syndromePlacenta praevia Placental abruption Post-partum haemorrhage requiring transfusion Pre-eclampsia (hypertension and proteinuria) Premature rupture of membranes Partus prematurusPartus immaturusPuerperal psychosis Severe infection e.g. pyelonephritis Stillbirth Surgical procedure in pregnancyOther, please specify

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 diseaseInflammatory disorders e.g. inflammatory bowel disease I.V. drug useLung diseaseMyeloproliferative disorders e.g.essential thrombocythaemia, polycythaemia veraNeoplasiaParaplegiaPsychiatric disorders Renal disease e.g. nephrotic syndromeSystemic lupus erythematosusOther, please specify



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3: Thrombophilia, including

Congenital trombophiliaActivated protein C Resistance / Factor V Leiden HomozygoteActivated protein C Resistance / Factor V Leiden HeterozygoteAntithrombin deficientie (Factor III)Protein C DeficiencyProtein S DeficiencyProthrombin gene variant (20210 G>A Factor II)Elevated Factor VIIIHyperhomocysteinemia

Acquired trombophiliaAnticardiolipin antibodiesLupus anticoagulantAnti-beta-2-glycoproteïne antibodies

4: Major maternal medical complications, includingAdult respiratory distress syndromeCardiac arrestCerebrovascular accidentDisseminated intravascular coagulopathyHELLPHaemorrhage requiring transfusionMendelson’s syndrome (chemical pneumonitis caused by aspiration during anaesthesia)Persistent vegetative stateRenal failure Required ventilationSepticaemiaOther, please specify

5: Infant complications, including:Chronic lung diseaseExchange transfusionIntraventricular haemorrhageJaundice requiring phototherapyMajor congenital anomalyNecrotising enterocolitisNeonatal encephalopathyRespiratory distress syndromeSevere infection e.g. septicaemia, meningitisOther, please specify



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