A S P

Surgi-Pharm

Advanced

“Successful labour induction is clearly related to the state of the cervix. Women with an unfavorable cervix who have not experienced cervical ripening phase before labor present the greatest challenge with regard to labor induction”�3

“Labour should only be induced if the Bishop Score is 5 or higher — this indicates sufficient cervical ripening”�2

Hygroscopic dilators (like Dilapan–S®) signifi cantly enhance cervicalripening and increase the Bishop Score enabling smootherlabour induction�4,�5

Dilator group (N =�214)

Dilator group (N =�112)

Dilator group (N =�214)

Dilapan (N =�90)

PGE2 group (N =�202)

Control group (N =�128)

PGE2 group (N =�202)

PGE2 gel (N =�95)

Uterine contraction during ripening phase�5

Uterine hyperstimulation and abnormal fetal heart rate changes�10

% of patients

Bishop score after 12 h

Post-ripening cervical score

Initial Bishop score

Admission cervical score

Deceleration of fetal heart rate (%)Uterine hyperstimulation (%)

p = 0,001

p = 0,001

Non-signifi cant diff erence

Gentle and predictable preinduction of labour Gentle and predictable preinduction of labour

47,1

3,15

0 1 2 3 4 5 6 0 1 2 3 4

5,26

Key benefi ts of Dilapan–S® in preinduction of labour:

• signifi cant increase in cervical ripening and Bishop Score�4,�5

• minimal risk of uterine hypestimulation and impact on the fetal heart rate�5,�6

• no pharmacological side eff ect• very high patient acceptability• accentuates the physiological processes of labour• easy application�3

Comparison with control group�4

Comparison with PGE�2�5

24,9

5,0

6,2

3,0

4,1

0 % 0 %

Dilapan–S®

“Onset of regular uterine activity as a result of preinductionis negative and unwanted side eff ect”�1

“The principal role of the agents used for cervical ripeningis to soften an unripe cervix independent of uterine activity”�3

3,0 3,0

0

0

1

1

2

2

3

3

4

4

5

5

6

6

7

7

7

7

6

6

5

5

4

4

3

3

2

2

1

1

0

0

6,54,2

Gentle. Predictable.

Dilapan–S®

Hygroscopic dilators produce minimal uterine activity during the ripeningprocess�5,�7

Recommendation for use:

4 mm x 55 mm

4 mm x 65 mm

3 mm x 55 mm

Type Indication

Cervical ripening prior to the induction of labour

Cervical preparation prior to the termination of pregnancy

When Dilapan–S® 4 mm can not be inserted in earlypregnancy, or when removal is to be accomplishedin less then 4 hours

Indications for use:

• cervical ripening prior to the induction of labour• cervical dilation prior to instrumentation of the uterine cavity, eg. termination of pregnancy, ERPC, fetal demise, etc.

Contra-Indications:

• clinically evident genital infection• menstruation

Gentle and predictable cervical preparationprior to the termination of pregnancy

Key benefi ts of Dilapan–S® in cervical preparation priorto the termination of pregnancy

• gradual atraumatic dilation

• signifi cantly reduces the risk of cervical injury and suture repair�8

• preserves full functionality of the cervix for future pregnancy

• no pharmacological side eff ects• minimising risk of uncontrolled abortions, eg. during the night• the greatest cervical dilation in the shortest timeframe of any osmotic dilators�8

• very high patient acceptability

RCOG* Evidence-based Clinical Guidelines, No 7, Nov 2011:�7

• After 14 weeks of gestation, osmotic dilators provide superior dilatation to medical methods (grade B)

Society for Family Planning Clinical Guidelines, 2008:�8

• Osmotic dilators are safe and eff ective for preoperative cervical preparation prior to D�&�E�** (level A)

* RCOG — Royal College of Obstetricians and Gynaecologists *�* D�&�E — dilation and evacuation

Required cervical dilation (according to the stage of pregnancy)

Cervical dilation

Number of dilators (type)

Time in situ

< 8. week 10. week 14. week > 18. week

6–8 mm

1 (3 mm)

2 hours

10 mm

1 (4 mm)

4 hours

13–15 mm

2 (4 mm)

6–10 hours

20�–24 mm

4 (4 mm)

Overnight

Dilapan–S®

Dilapan–S® is an osmotic hygroscopic dilator produced from a patented Aquacryl hydrogel that guarantees consistency of action. It is a rigid gel rod that increases in volume by absorbing fl uids so gradually dilating the cervix. After 4 to 6 hours, the 3 mm rod will have expanded to 8.3–10 mm and the 4 mm rod up to 10–12,5 mm.Simultaneously, Dilapan–S® initiates endogenous prostaglandin release causing collagen degradation which softens the cervix.

Dilapan–S® is sterilized by irradiation. It is manufactured in an ISO 9001 Certifi ed facility and is fully CE Certifi ed under the Medical Device Directive (EN46002). Approved by FDA for sale in the United States.

Gentle. Predictable.

Sources:

�1. Roztočil et al.: Kontroverze a chyby v indukci porodu, Moderní gynekologie a porodnictví 16/2007, str. 38–462. Roztočil A.: Preindukce a indukce porodu — Doporučený postup. Revize doporučeného postupu 20103. Ramos, L. S. et al.: Induction of Labor, Obstetrics and Gynecology Clinics of North America, 32 (2005), p. 181–2004. Gilson, J. et al: A prospective randomised evaluation of hygroscopiccervical dilator, DILAPAN, in the pre- induction ripening of patients undergoing induction of labor, American Journal of Obstetrics and Gynecology, July 1996, Vol. 175, No 15. Krammer, J. et al.: Pre-induction cervical ripening: A randomised comparison of two methods, Obstetrics and Gynecology, Vol 85, No 4, April 1995, p. 614–�6186. Jozwiak, M. et al.: mechanical methods for induction of labor (review), Cochrane review, The Cochrane Library 2012, Issue 37. Royal Colleqe of Obstetricians and Gynaecologists: The Care of Women Requesting Induced Abortion: Summary. Evidence-based Clinical Guideline, No 7, November 20118. Society of Family Planning: Clinical Guidelines — Cervical preparation for trimester surgical abortion prior to 20 weeks of gestation, Contraception 76, 20079. Society of Family Planning: Clinical Guidelines: Guidelines — Cervical preparation for surgical abortion from 20 to 24 weeks gestation, Contraception 77, 200810. Chua, S. et al.: Preinduction Cervical Ripening: Prostaglandine E2 Gel vs Hygroscopic Mechanical Dilator, J. Obstet. Gynaecol. Res., Vol 23, No 2, 1997, 171–177

Dilation achieved, depending on the time in situ and number of dilatorsinserted (approximate range):

1

1

1

1

Number of dilators (4 mm) Time in situ (hours) Expected dilation (mm +/– 0.5)

2 7.8�–�10.0

10.0�–�11.2

10.1�–�12.5

12.7�–�14.6

4

6

24

Dilation will be less if the 3�mm Dilapan–S® is used.

Tips for insertion:

• Moisten Dilapan–S® with sterile water or saline to lubricate the surface prior to insertion.

• A tenaculum may be used to stabilise the cervix and to straighten the cervical canal.

• Grasp Dilapan–S® at the handle. Gradually and without undue force, insert Dilapan–S® until it traverses the external and internal os.

• Do not insert Dilapan–S® past the handle. The border of the handle should rest at the external os.

• If inserting multiple Dilapan–S®, repeat the above steps for each one.

• Do not leave Dilapan–S® in place more than 24 hours.

• To remove Dilapan–S®, grasp the handle only with forceps and apply steady downward traction, in line with the long axis of the dilator. Do not twist excessively and do not use the marker string.

• For detailed instructions for use, please read the leafl et in each pack.

Dilapan–S®

Gentle. Predictable.

Gentle and predictable cervical ripening in labour preinduction

• signifi cant increase in cervical ripening and Bishop score enabling

• minimal risk of uterine hyperstimulation

• ects

• very high patient acceptability

• accentuates the physiological processes of labour

DILAPAN–S is an osmotic cervical

dilator made of a patented AQUACRYL

hydrogel. It is a rigid hygroscopic

gel rod that increases its volume by

absorbing fl uids and gradually dilates

the following dilation is reached — from

respectively. Indications for use: cervical

ripening prior to the induction of labour. Cervical

dilation prior to the instrumental procedures

in the uterine cavity, such as pregnancy termination.

Advanced Surgi-Pharm Inc

850 Halpern Ave., Dorval, Qc, H9P 1G6

www.surgmed.com www.dilapan.com

Sources: 1. Gilson,J. et al: A prospective

randomised evaluation of hygroscopic cervical dilator,

DILAPAN, in the pre-induction ripening of pa-

tients undergoing induction of labor, American Journal of Obstetrics and Gyneco-

logy, July 1996, Vol. 175, No 1.2. Krammer, J. et al.: Pre-

induction cervical ripening: A randomised comparison

of two methods, Obstetrics and Gynecology, Vol 85, No

3. Jozwiak, M. et al.: mecha-nical methods for induction of labor (review), Cochrane

review, The Cochrane Library 2012, Issue 3 Re

v 01

. Oct

201

2

A S P

Surgi-Pharm

Advanced