23/03/2006

יישום הנחיות חדשות למניעת פקקת ורידית לאחר לידה בבית

חולים הדסה

Implementation of New Guidelines for Prophylaxis

of Postpartum Venous Thromboembolism at

Hadassah University Hospital – Surveillance of

Adherence to Guidelines and Adverse Events

עבודת הגמר של התלמידה רבקה ויינשטיין

ס לרפואה של האוניברסיטה "כמילוי חלק מהדרישות לשם קבלת תואר דוקטור לרפואה מטעם ביה

.ירושלים, העברית והדסה

:בהדרכתם של

מחלקת , ר אייל ענתבי"ד

-הדסה הר, נשים ויולדות

הצופים

המחלקה , דוד ורון' פרופ

כרם-הדסה עין, להמטולוגיה

מרכז , מאיר ברזיס' פרופ

, לאיכות ובטיחות קלינית

ח הדסה"בי

INTRODUCTION

The increase in risk of thromboembolic events during pregnancy is well-established,

and pregnancy is recognized as a significant risk factor for development of deep-vein

thrombosis and pulmonary embolus. In accordance with this, prophylaxis protocols

are practiced worldwide for pregnant women at risk. However, recent studies have

shown that the risk of venous thromboembolism (VTE) is even greater postpartum

than it is antepartum1,2, and VTE has been found to be one of the major causes of

morbidity and mortality associated with labor, delivery and Caesarean section3. The

Royal College of Obstetrics and Gynecology (RCOG) has recognized this, and has

published guidelines for VTE prophylaxis for women at risk of developing such

complications3. The guidelines are based on assessing the risk in every mother, based

on personal variables, and they outline cases where prophylaxis is indicated.

Low-molecular-weight heparin (LMWH) is considered effective for VTE

prophylaxis4, with a higher cost-effectiveness profile than unfractioned heparin5, and

is safe for use in pregnancy and delivery6,7. Therefore, LMWH is the drug of choice

for VTE prophylaxis in these women.

The obstetrics & gynecology departments at Hadassah hospitals have adapted and

adopted the RCOG guidelines, and beginning March, 2004 have started to implement

them on their patients8. These guidelines substantially broaden the indications for use

of LMWH compared to those previously practiced, and so their implementation was

expected to increase the use of LMWH on the maternity wards. This increase in use of

medication, especially in young, and for the most part healthy, women, raises the

3

question of the cost of implementation of this protocol in the way of side-effects and

complications.

Previous studies monitoring the obstetric use of LMWH have concentrated primarily

on pregnancy, not delivery. In conjunction with the new guidelines focusing on the

time of delivery, we aimed to examine the safety of its use at that time.

The aim of this study was to monitor the adherence to the guidelines in the obstetrics

wards at the Mt. Scopus campus of Hadassah hospital, and see what, if any,

complications arise from the increase in use of LMWH. We found no studies

monitoring the implementation of these or similar guidelines. We found a single

study9 examining the use of peripartum prophylactic LMWH. In this study the

regimen appeared to be both safe and effective. In accordance with this, the

hypothesis this study was based on was that there would be no significant increase in

complications in women receiving low-dose LMWH, and as its effectiveness in

preventing VTE has been established, it will prove to be an effective prophylactic

measure.

4

METHODS

This study was a descriptive, observational prospective matched case-control study.

Data was gathered as patients were treated, and complication rates were compared to

those of obstetrically-matched controls (i.e women with the same number birth, same

method of delivery, and similar age range).

Subjects

All women delivering a baby at both campuses of Hadassah hospital, if identified by

the treating physician as fulfilling the criteria specified in the protocol (see tables 1 &

2), received LMWH thromboprophylaxis with enoxaparin (Clexane™) 40 mg once

daily. The first 108 women receiving thromboprophylaxis that were identified by the

researcher were monitored for hemorrhagic complications throughout the duration of

their hospital stay (while LMWH was being administered) by filling out a

questionnaire, and by a telephone follow-up a few weeks post-partum.

Controls were matched to cases for age (<20, 20-24, 25-29, 30-34, 35-39 or 40+),

parity (1, 2, 3, 4, 5 or 6+) and method of delivery (vaginal vs. Caesarean section). No

other matching was done as these are primarily normal, healthy women, and women

with other medical conditions were usually by definition in the high-risk, prophylaxis-

indicated group. For every case accumulated a matched control was sought and, if

found, she received the same questionnaire and the same follow-up phone call.

5

Every woman receiving thromboprophylaxis who had a matched control entered the

study, with her control, as a couple. For every parameter followed, the answers given

by the case were compared with those of the control.

The study was conducted between March 2004 and June 2005. During this period 81

women after vaginal delivery and 27 women after Caesarean delivery who received

prophylactic enoxaparin injections participated in the study. Of these, matched

controls were found for 71 vaginal-delivery women and 18 Caesarean-delivery

women, for a total of 89 case-control pairs entering the statistical analysis. Clinical

characteristics of the women are shown in table 3. There was no statistically

significant difference of age or parity between the two groups. Of note, there were

women in both groups who were given a questionnaire and never returned it. We have

no record of these women.

Methods

Adherence to guidelines was assessed by evaluating the women in both groups for an

indication for thromboprophylaxis and calculating the percentage of control group

with a known indication on the one hand, and the treated women for a proper

indication on the other hand.

Questionnaires were composed for the purpose of this study (one for vaginal delivery,

one slightly different for Caesarean delivery). The questionnaires collected general

demographic information and relevant information about the delivery, the reason for

enoxaparin administration in cases, hemoglobin levels at admission and lowest

documented post-partum, and questions about various hemorrhagic manifestations

6

during the time of hospitalization. English translation of the questionnaires appears in

the appendix.

The questionnaires were distributed to the women along with an explanation about the

questionnaire and the study. According to the woman’s wishes, the questionnaire was

either completed it with her daily or left for her to complete herself and return at the

time of hospital discharge. When necessary, a translator was used for women who

spoke only Arabic.

At least 6 weeks post-partum, each woman received a follow-up phone call (see table

4). The purpose of the phone call was to determine if there were any hemorrhagic

complications immediately after discharge that would have been missed on the

questionnaire, if post-partum bleeding was prolonged in women receiving enoxaparin,

if there was a significantly lower hemoglobin level at follow-up blood count in

women receiving enoxaparin, and if there were any puerperial thromboembolic

complications in any of the women.

The primary endpoints of the study were to determine whether guidelines were being

adhered to and whether there were more peri-partum hemorrhagic complications in

the treated women compared to their matched controls. Secondary endpoints included

differences in late post-partum hemorrhages and prevention of venous

thromboembolic events.

7

Statistical analysis

Sample size estimation was based on differences between cases and controls in

percentage of hemorrhagic complications. Assuming that only a difference of 10% or

higher between the two groups is clinically significant (anticipating 5% in controls vs.

15% in cases), with α = 5% and power = 80%, a sample size of 52 pairs of case-

control women was calculated as necessary to prove that such a difference is

statistically significant. Any difference of less than 10% was considered to be

clinically insignificant.

Data was analyzed with SPSS statistical software .When referring to binary

parameters, the McNemar test for matched samples was applied to test whether the

difference between the cases and controls was statistically significant. A one-tail p

value was used, as it is not likely to assume that enoxaparin injections will decrease

rates of hemorrhage. When referring to parameters with continuous values, e.g.

decrease in hemoglobin or duration of post partum bleeding, data was analyzed by the

means of the t-test. The t-test was further used for evaluation of the appropriateness of

the age and parity matching performed. This was done with the aid of Microsoft Excel

software.

8

RESULTS

Of the 89 women receiving prophylactic enoxaparin, we have record of the indication

for it in 84 women (94%), indicating 6% of apparent overtreatment. Of these, 66

(78%) had varicose veins, 11 (13%) had known or suspected thrombophilia, and 12

(14%) had other risk factors, including advanced age, multiparity, obesity,

preeclampsia, chorioamnionitis, prolonged immobilization, Behcet disease and

emergency Caesarean section.

Of the 89 women not receiving prophylactic enoxaparin, we have record of an

indication for it by our guidelines in 6 (7%) of women, indicating 93% adherence to

guidelines. In all of these cases, the indication is a combination of age and parity.

Early hemorrhagic complications are represented in table 5. As to complications in

the cut (surgical incision, episiotomy site or perineal tear) – of 71 pairs of women who

delivered vaginally, there was only one pair in which both women had either an

episiotomy or a perineal tear, and so the sample size for this category is extremely

small – 18 pairs who had a Caesarean plus the above-mentioned single pair. This

sample size is too small for statistical analysis, but we can report that there were no

controls with any reported complications, whereas there were 2 women (11%) who

were getting enoxaparin injections after Caesarean delivery who had reported

complications – one with incomplete closure of the wound with minor bleeding from

the site of the incision, and one with wound infection.

9

The decrease in hemoglobin around delivery, i.e. hemoglobin levels at the time of

admission minus the lowest measured hemoglobin level during hospitalization, was

measured and compared between cases and controls. In women receiving enoxaparin

injections the mean hemoglobin decrease (and standard deviation) was 1.1 g% (0.87),

and in the control women the mean decrease was 1.1 g% (0.81) as well. The mean

difference between the decrease in treated women and the decrease in controls was

-0.03 (1.02) (non-significant p value).

As to post-partum bleeding duration, the mean duration in treated women was 4.9

weeks (standard deviation 2.42) versus 5.2 weeks (SD 3.05) in control women. The

mean difference between bleeding duration in treated women and control women was

-0.24 weeks (SD 3.85) (non-significant p value).

As to the long-term hemorrhagic complications, the results are anecdotal and not

statistically significant. In the treated group we had one woman report prolonged mild

epistaxis, one woman reported slow wound healing and one woman (mentioned above

with wound infection) who was re-admitted for an additional month and had to have

the wound re-opened and surgically drained. In the control women, there were 3

women who reported prolonged post-partum bleeding, and one woman who reported

wound hemorrhage and infection one week post-partum. She was treated in the

emergency room and discharged to her home.

As to thromboembolic complications, we had one treated woman who reported

saphenous vein thrombosis after stopping the prophylactic enoxaparin, and one

control woman who reported a pulmonary embolus.

10

As to hemoglobin levels 6 weeks post partum, there were very few women who went

to have it measured, and so we only have 6 case-control pairs where this value is

available for both women. Of these 6 pairs, there were 4 pairs in which the

hemoglobin level was normal (≥11 g%) in both women, and two pairs in which the

hemoglobin was normal in the treated woman and low (<11 g%) in the control

woman.

11

DISCUSSION

The results of this study show high rates (93%) of adherence to guidelines. The study

further shows higher rates of hemorrhagic complications in women receiving

enoxaparin injections as compared to matched controls not receiving those same

injections, especially in women who delivered vaginally. This is contrary to what we

expected, due to the known low rates of complications for the use of LMWH in

general. However, looking more closely at the complications that arose and

comparing them to the possible severity of deep vein thrombosis and pulmonary

embolus, which the LMWH is there to prevent, we believe that the clinical

significance of these complications is quite low.

Broken down to specific complications, we found no single complication that was

significantly more common in women receiving LMWH. The most significant

complication reported in the women who were getting prophylactic LMWH was the

degree of post partum bleeding. This was a very subjective parameter, determined by

the woman’s interpretation of the degree of her bleeding. While it is reasonable to

assume that in a large cohort women’s overall subjective interpretations shouldn’t

vary from (case) group to (control) group, in this case the women were not blinded to

the treatment, and so treated women all knew they were on blood-thinning injections,

a point which may bias their view.

As to gingival bleeding, there was perhaps a tendency towards more bleeding in

treated women. However, this was not statistically significant, and furthermore, this is

12

not a clinically significant complication, certainly if weighed against deep vein

thrombosis or pulmonary embolus.

As to epistaxis, there was practically no difference between the groups.

As to complications at the site of surgical incision, episiotomy or perineal tear, the

overall prevalence of these complications is too low for this study to have reached any

statistically significant results, but we have one case of a treated woman with severe

wound hemorrhage and infection and one woman with mild hemorrhage from the

surgical incision, and on the other hand a control woman with intermediate-severity

wound infection that necessitated a visit to the emergency room. Based on this data,

there is no evidence that LMWH injections increase the risk of local complications,

although larger studies are necessary to further investigate this point.

As to complications at the site of anesthesia (spinal or epidural catheter), we were

pleased to see there was not a single complication reported. We attribute this to the

great care that was taken during introduction of our treatment protocol to the exact

manner in which spinal cord puncture can be combined with LMWH injections. The

obstetricians, hematologists and anesthesiologists at our institution agreed on

acceptable guidelines which were strictly adhered to, including a 12-hour window

between any injection of LMWH and insertion or removal of needle or catheter, and

6-8 hour window between any insertion or removal of needle or catheter and any

injection of LMWH.

13

As to our only completely objective parameter for degree of hemorrhage, the decrease

in hemoglobin levels, there was no clinically or statistically significant difference

between cases and controls, further indicating that there is no evidence that LMWH

prophylaxis for VTE increases rates of peri-partum hemorrhage.

The long-term follow-up of the women didn’t demonstrate an increase in late

complications due to use of enoxaparin. The bleeding duration was no longer in

treated women than in controls. If anything, it was a mean of 0.24 weeks (which is 1.6

days) longer in the control women, although this was not statistically significant and

the standard deviation was high. Furthermore, as the half-life of enoxaparin is

approximately 4.5 hours10, it is highly unlikely that prolonged post-partum bleeding,

lasting about 5 weeks or longer, can be attributed to the LMWH injections.

As to thromboembolic events, the endpoint the enoxaparin came to prevent, we did

not intend to achieve any data on its efficacy in our study, due to the low prevalence

of these events in the general population and thus the large sample size necessary to

attain significant results. However, we did have a control woman who reported a

pulmonary embolus after her discharge, and we did have a treated woman who

developed saphenous vein thrombosis after stopping LMWH injections. Both of these

findings may indicate the efficiency and the importance of the use of LMWH for

prophylaxis of venous thromboembolic events.

The study design left room for certain bias. Subject selection was unbiased, but

finding matched controls for certain women was difficult. For example, older women

or multiparas, especially if undergoing Caesarean section, fall into the category of

14

LMWH-indicated very easily, and while we matched these parameters, we had to

group the exteremes (i.e. age 40+, parity 6+), and it is posssible the controls were at

the lower end of the spectrum, and the subjects – at the higher end. Furthermore, as

only the women with a matched control ended up entering the study, we have 19

treated women who did not have a matched control. These women did not enter

statistical analysis and their rates of complications were not measured. Another

possible confounder is measurement bias, as the reports of complications were given

subjectively by the women, while the treated women knew they were on blood

thinners.

Based on the results of our study, we recommend the use of enoxaparin 40 mg once

daily for peripartum thromboprophylaxis in women who are at high risk of

thromboembolic events, especially in women who delivered by Caesarean section.

Those women are considered at higher risk for VTE and our study suggests increased

safety of the prophylxis in them. However, further studies are necessary to ascertain

the efficacy of LMWH in prophylaxis of VTE and the safety of this regimen.

15

SUMMARY

The increase in risk of thromboembolic events during pregnancy is well-established,

and pregnancy is recognized as a significant risk factor for development of deep-vein

thrombosis and pulmonary embolus. As part of safety and quality control measures

being taken to improve the quality of care at Hadassah obstetrics wards, the

obstetricians, hematologists and quality control center collaborated to determine

guidelines for prophylaxis of peri-partum thromboembolic events. Prophylaxis was

achieved by injections of low-molecular weight heparin (enoxaparin, Clexane™), 40

mg once daily, to women in the maternity wards at Hadassah hospital who were

considered to be at high risk for thromboembolic events (as determined by advanced

age, advanced parity, obesity, immobility and Caesarean delivery). The aim of our

study was to monitor the physicians’ adherence to the new guidelines and the rates of

complications brought on by this additional treatment.

Adherence to guidelines was assessed by monitoring 178 women who delivered

during 2004-2005 and comparing the existence of an indication for

thromboprophylaxis with the receipt of thromboprophylaxis. These women were

further questioned about the severity of uterine bleeding post partum, as well as other

bleeding complications, both immediately after delivery (while still in the hospital)

and a couple of months post partum. The rate of the reported complications was

compared in 89 women receiving thromboprophylaxis with that in 89 controls, not

receiving thromboprophylaxis and matched to the treated women for age, parity and

method of delivery. The statistical analysis was performed by the McNemar test for

matched controls.

16

Adherence of treating physicians to guidelines was found to be 93%. In the control

group, 6 women were identified who had an indication for treatment and should have

received thromboprophylaxis. In the group of treated women, we had record of the

indication for treatment in 84 of 89 (94%) – apparent overtreatment of 6%.

The rates of early complications (identified at the time of peri-partum hospitalization)

are summarized in the table below:

Rates of complications in treated women and control women % (95% CI)

Treated women Control women P value

Overall hemorrhagic

complications

63% (53-72) 48% (38-59) 0.04

Overall complications – vaginal

delivery

66% (55-76) 49% (38-61) 0.03

Overall complications –

Caesarean delivery

50% (28-72) 44% (23-67) NS

Average hemoglobin decrease

(gm%)

1.1 1.1 NS

Pulmonary Embolus 0 1 NS

CI – confidence interval

The hemorrhagic complications reported were not serious, and there was not a single

reported complication at the site of regional anesthesia. The type of complication

reported was primarily heavy uterine bleeding, and there were a number of cases of

gingival bleeding, epistaxis or complications at the site of surgical incision. Post

17

partum bleeding duration was similar in both groups (approximately 5 weeks). There

was no significant difference between the two groups in the incidence of other

complications. One woman in the control group suffered a pulmonary embolus, and

one woman suffered from superficial vein thrombosis despite thromboprophylaxis.

In summary, we found high rates of adherence to the new guidelines for peri-partum

thromboprophylaxis. This was associated with slightly higher rates of various

hemorrhages, but these were clinically insignificant. We propose that application of

peri-partum thromboprophylxis is feasible and appears to be safe. However, larger

studies are necessary to further evaluate the safety of this treatment.

18

סיכום

. לידתית-הריון מהווה גורם סיכון ליצירת קרישים ותסחיפים הגורמים לעיתים אף לתמותה סב

על סמך הספרות נוסחו הנחיות , במסגרת פעילות של שיפור איכות ובטיחות במיילדות בהדסה

) ג ביום" מ40, קלקסן תת עורי(הוחל בטיפול מניעתי נוגד קרישה : למניעת קרישי דם לאחר לידה

). חוסר ניידות ולידה בניתוח קיסרי, ולדנות גדולה, השמנה, גיל מבוגר(ולדות עם סיכון מוגבר לי

מטרת המחקר היתה לבדוק את היענות הרופאים בביצוע ההנחיות החדשות ואת שיעור

.ההיארעות של סיבוכי הטיפול

ובדיקת 2004-2005 יולדות בשנים 178- י בחינה של הטיפול שניתן ל"ההיענות להנחיות נבדקה ע

ודימומים היולדות נשאלו אודות חומרת הדימום הרחמי. קיום התוויה לטיפול מונע קרישה

יולדות שקיבלו 89שיעור הסיבוכים הושווה בין . מהלידה ועד כחודשיים לאחר מכן, נוספים

ולדות י( יולדות שלא קיבלו טיפול זה ושהיוו את קבוצת הביקורת 89-טיפול מניעתי נוגד קרישה ל

.McNemar בעזרת מבחן ) מספר וצורת הלידה , מותאמות לגיל

6בקבוצת הביקורת נמצאו . 90%היענות הרופאים המטפלים להנחיות החדשות נמצאה מעל

נמצאה ,המטופלות בקבוצת .ואשר היו צריכות לקבל קלקסן ,עם התוויה לטיפול) 7%(יולדות

הטבלה מסכמת את שיעורי . 6%פול יתר בשיעור של טי-) 94%( יולדות 84התוויה לטיפול בקרב

.הסיבוכים בזמן האשפוז

CI) 95%-אחוז ו(שיעורי הסיבוכים בקרב מטופלות ובקרב הביקורת

p value ביקורת מטופלות

53-72) 63%( 38-59) 48%( 0.04 (n=89)שיעור דימומים כ"סה

55-76) 66%( 38-61) 49%( 0.03(n=71)בלידה טבעית

28-72) 50%( 23-67) 44%( NS (n=18)בלידה קיסרית

Hg 1.1 gm% 1.1gm% NS-ממוצע ירידה ב

NS 1 0 תסחיף ריאתי

סוג הדימום היה . הדימומים שדווחו היו קלים ולא דווח על אף סיבוך באזור ההרדמה האזורית

מהאף או בצלקת , אולם היו גם מקרים מועטים של דימום מהחניכיים, כ דימום רחמי מוגבר"בד

5-כ(משך הדימומים המאוחרים בתקופת משכב הלידה היה דומה בשתי הקבוצות . הניתוח

19

לא נמצא הבדל מהותי בין שתי הקבוצות בשיעור היארעותם של ). שבועות בשתי הקבוצות

ויולדת אחרת סבלה , יולדת אחת בקבוצת הביקורת סבלה מתסחיף ריאתי. סיבוכים אחרים

.י הרגל השטחיים למרות הטיפול המניעתימקריש בוריד

טיפול זה . נמצאה היענות גבוהה להנחיות החדשות למתן טיפול מונע קרישי דם לאחר לידה: דיון

אולם לא היתה לכך משמעות , בעליה בשיעור הדימומים הקלים שלאחר לידה אמנם היה כרוך

.קלינית

דרוש מחקר גדול . ת בסיכון הינו בר ביצועיישום ההנחיות לטיפול נוגד הקרישה ליולדו ,לסיכום

.להוכחת בטיחותו של הטיפול, יותר

20

APPENDIX

Table 1 – Protocol for venous thromboemoblism (VTE) prophylaxis in vaginal

delivery

One of the following:

History of previous thromboembolic event

Congenital or acquired thrombophilia

Chorioamnionitis or other severe infectious disease

Paraparesis

Severe varicose veins or superficial vein thrombosis

Serious post-partum immobility

Nephrotic syndrome

Severe post-partum hemorrhage (>1000 cc)

Two of the following:

Age > 40 years

Obesity – weight >80 kg

Multiparity - ≥6 birth

Prolonged labor - ≥ 12 hours

Preeclampsia, eclampsia

Pre-partum immobilization (≥4 days)

Severe systemic disease (e.g. cardiac, IBD, malignancy)

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Table 2 - Protocol for venous thromboemoblism (VTE) prophylaxis in Caesarean

section

One of the following:

History of previous thromboembolic event

Congenital or acquired thrombophilia

Prolonged or extensive surgery

Chorioamnionitis or other severe infectious disease

Paraparesis

Severe varicose veins or superficial vein thrombosis

Serious post-partum immobility

Nephrotic syndrome

Severe post-partum hemorrhage (>1000 cc)

Age > 35 years

Obesity – weight >80 kg

Emergency surgery

Multiparity - ≥4 birth

Prolonged labor - ≥ 12 hours

Preeclampsia, eclampsia

Pre-partum immobilization (≥4 days)

Severe systemic disease (e.g. cardiac, IBD, malignancy)

22

Table 3 – Clinical characteristics of women in the study

N Minimum Maximum Mean SD

Age of treated

woman 89 22 44 32.92 5.039

Age of control

Woman 89 21 43 32.70 5.030

Number of birth

treated woman 89 1 13 4.75 2.643

Number of birth

control woman 89 1 11 4.65 2.473

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Table 4 – Questionnaire at follow up phone call

1. How long post-partum did your bleeding last?

2. Did you have any clinically significant hemorrhage after being

discharged?

3. Did you have any medical condition requiring a visit to the doctor or

emergency room between discharge and the time of this phone call?

4. Did you repeat a complete blood count after discharge? If so, what was

the hemoglobin level?

5. Do you have any other questions or comments?

24

Table 5 – Early hemorrhagic complications: overall rates and rates of specific

complications

N

Complications

only in treated

woman (%)

Complications

only in control

woman (%)

P value

Overall

complications 89 31 (35%) 18 (20%) 0.04

Overall

complications

– vaginal

delivery

71 24 (34%) 12 (17%) 0.03

Overall

complications

– Caesarean

delivery

18 7 (39%) 6 (33%) NS

Severe post-

partum

bleeding1

87 21 (24%) 12 (14%) 0.08

Gingival

bleeding2 89 20 (23%) 13 (15%) 0.15

Epistaxis 89 8 (9%) 7 (8%) NS

Complications

at site of

anesthesia3

89 0 0 NS

Complications

at site of cut4 19 2 (11%) 0 NS

NS – not significant

1 Self-reported by women as bleeding heavier than normal 2 Any reported bleeding, including during brushing teeth, irrespective of whether bleeding is always present or new-onset gingival bleeding 3 i.e. at site of epidural catheter or spinal needle insertion 4 surgical incision, episiotomy or perineal tear

25

Appendix 1 – Questionnaire for women after a vaginal delivery (translated from

Hebrew)

Date of delivery:

Age:

Pregnancy #:

Birth #:

Course of delivery: Epidural anesthesia – yes/no

Episiotomy – yes/no

Perineal Tear – yes/no

Hemoglobin level at time of admission:

Lowest hemoglobin level during hospitalization:

Reason for Clexane™ administration:

Home and/or cell phone number (for follow-up phone call):

Parameter Day 1 post-partum Day 2 post-partum Day 3 post-partum

Complication at

site of

episiotomy/stitches

(if present)

Self-reported

degree of vaginal

bleeding (light,

normal, heavy)

Complication at

site of epidural

catheter (if present)

Epistaxis present

Gingival bleeding

present

Complications during hospitalization:

26

Appendix 2 - Questionnaire for women after a Caesarean delivery (translated from

Hebrew)

Date of delivery:

Age:

Pregnancy #:

Birth #:

Emergency surgery – yes/no

Indication for surgery:

Method of anesthesia:

Hemoglobin level at time of admission:

Lowest hemoglobin level during hospitalization:

Reason for Clexane™ administration:

Home and/or cell phone number (for follow-up phone call):

Parameter Day 1 post-

partum

Day 2 post-

partum

Day 3 post-

partum

Day 4

post-

partum

Day 5

post-

partum

Complication at

site of incision

Self-reported

degree of vaginal

bleeding (light,

normal, heavy)

Complication at

site of anesthesia

(if present)

Epistaxis present

Gingival bleeding

present

Complications during hospitalization:

27

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