The Cook Cervical Ripening Balloon Preinduction Cervical Dilation

1. The Cook Cervical Ripening BalloonPreinduction Cervical Dilation Erich Fl�gel, MD Dear Auditorium. My name is Erich, this presentation is focused on medical associated staff.Dear Auditorium. My name is Erich, this presentation is focused on medical associated staff.

2. What do you think about Cooks Balloon?What do you think about Cooks Balloon?

3. Medicine has no 0 to 1 discrimination like technics or the computers.Medicine has no 0 to 1 discrimination like technics or the computers.

4. Medicine is dealing with �unsure� knowledge. We read and interprete clinical parameters, we look for smptoms. All together they get called syndroms, finally we think about a disease. This is the work of medical doctors.Medicine is dealing with �unsure� knowledge. We read and interprete clinical parameters, we look for smptoms. All together they get called syndroms, finally we think about a disease. This is the work of medical doctors.

5. Doctors use a kind of �Holy Bible� for right decison making: The Internetlink �PUBMED�. This is a summary of published former medical associated experiences. A empiric medical �Wikipedia� � or like potential stem cells of new inventions. These are some PubMed rated publications, like: Doctors use a kind of �Holy Bible� for right decison making: The Internetlink �PUBMED�. This is a summary of published former medical associated experiences. A empiric medical �Wikipedia� � or like potential stem cells of new inventions. These are some PubMed rated publications, like:

6. You get thousands of publications with the serch string �preinduction cervical dilation�� or �cervical ripening� of �unfavourable cervix� or �induction of labor�. There is some evidence: Many publications are from 2004-2006 and there is sometimes mixture of the terms: ripening-dilation-induction of labor.You get thousands of publications with the serch string �preinduction cervical dilation�� or �cervical ripening� of �unfavourable cervix� or �induction of labor�. There is some evidence: Many publications are from 2004-2006 and there is sometimes mixture of the terms: ripening-dilation-induction of labor.

7. Is the Mechanical Ripening Era Over ? Since 15 years I am in contact with Gynaecologists: First for drugs like contraceptives and hormone replacement therapy, later for infections and for oncology, then selling medical devices for ESTECH LINVATECH, last 2 years for collecting umbilical cord blood � placenta residual blood for stemcells for the future. A general statement of Austrian Gynaecologic KOLs is: This is a ancient method, but less dangerous regarding drug sideeffects. We have 1700 Gyns in Austria, about 30% are �A-rated� about this indication.Since 15 years I am in contact with Gynaecologists: First for drugs like contraceptives and hormone replacement therapy, later for infections and for oncology, then selling medical devices for ESTECH LINVATECH, last 2 years for collecting umbilical cord blood � placenta residual blood for stemcells for the future. A general statement of Austrian Gynaecologic KOLs is: This is a ancient method, but less dangerous regarding drug sideeffects. We have 1700 Gyns in Austria, about 30% are �A-rated� about this indication.

8. Is PubMed evidence really a mirror of our dayly medical challenges?Is PubMed evidence really a mirror of our dayly medical challenges?

9. Let�s talk about �the baby The baby sleeps in the uterus. The funktion of the cervix is: to close the uterus and to hold back the baby. The uterus predominant consists of contractile smooth muscle cells. The cervix has less cells, but more connective tissue, mainly collagen fibers-less elastic fibers. The intercellular matrix has high concentration of glycanes and hyaluronic acid with high water binding affinity.The baby sleeps in the uterus. The funktion of the cervix is: to close the uterus and to hold back the baby. The uterus predominant consists of contractile smooth muscle cells. The cervix has less cells, but more connective tissue, mainly collagen fibers-less elastic fibers. The intercellular matrix has high concentration of glycanes and hyaluronic acid with high water binding affinity.

10. Efface AND Dilate Every ripening has always the same TWO steps: FIRST Effacement, SECOND Dilation. Effacement is: Cervix length decreases from 4cm towards zero cm Dilatation is: Opening of the cervix from 1-10cm.Every ripening has always the same TWO steps: FIRST Effacement, SECOND Dilation. Effacement is: Cervix length decreases from 4cm towards zero cm Dilatation is: Opening of the cervix from 1-10cm.

11. Efface AND Dilate Here you see again: FIRST the cervix gets shorter and shorter, from lenght 4cm downward towars zero cm. Finally the cervix wall looks like: disappeared. This is the �full effaced stadium�. After this the second step starts: Opening of the cervix, opening of the os externum (in same place with os internum). From diameter 1cm to 10cm: This is end of the second step: Stadium of �full dilated�.Here you see again: FIRST the cervix gets shorter and shorter, from lenght 4cm downward towars zero cm. Finally the cervix wall looks like: disappeared. This is the �full effaced stadium�. After this the second step starts: Opening of the cervix, opening of the os externum (in same place with os internum). From diameter 1cm to 10cm: This is end of the second step: Stadium of �full dilated�.

12. Efface AND Dilate Effacement is Ex-facing of the cervix Os internum is at the same place as os externum cervicis �Thinning out� like Disappearing of cervix Dilatation / Dilation is Opening of the os externum cervicis From Diameter 1cm to diameter 10cm In summaryIn summary

13. Will you act like that ? When the cervix is not fully ripped, the insertion of a catheter would hurt. Inflating a balloon would hurt. Here Dilation of the cervixchannel starts BEFORE effacement is finished! This is not according to our physiological experiences.When the cervix is not fully ripped, the insertion of a catheter would hurt. Inflating a balloon would hurt. Here Dilation of the cervixchannel starts BEFORE effacement is finished! This is not according to our physiological experiences.

14. Amniotic Sac �Opposite� of the cervix the baby swims in his amniotic balloon.�Opposite� of the cervix the baby swims in his amniotic balloon.

15. PROMpremature rupture of membrans A dilatation of the cervix without fully effacement has high risk of a prolaps of the amniotic sac into the cervic channel. This is high risk for prom and following fast cesarian scetio.A dilatation of the cervix without fully effacement has high risk of a prolaps of the amniotic sac into the cervic channel. This is high risk for prom and following fast cesarian scetio.

16. Bishop Score All these parameters are counted together in the so called �Bishop score�. High score indicates a favourable cervix. Further: CTG Cardio Toco Gramm: recording the fetal heartbeat and the uterine contractions during pregnancy, typically in the third trimester. The machine used to perform the monitoring is called a cardiotocograph, more commonly known as an electronic fetal monitor (EFM). All these parameters are counted together in the so called �Bishop score�. High score indicates a favourable cervix. Further: CTG Cardio Toco Gramm: recording the fetal heartbeat and the uterine contractions during pregnancy, typically in the third trimester. The machine used to perform the monitoring is called a cardiotocograph, more commonly known as an electronic fetal monitor (EFM).

17. Physiology of cervical ripeningand dilatation Maturation of the cervix is the result of a coordinated biochemical process, which at least initially is independent of uterine contractions. During maturation,water is retained within the cervical tissue with reorganization of collagen fibrils. Humoral mediators such as prostaglandins, estrogen,and nitric oxide activate proteases, which digest collagen matrix. An abacterial or bacterial inflammatory reaction accelerates this process. Invading inflammatory cells release cytokines, nitric oxide, and proteases,which contribute to the loosening of the collagen structure. Finally, the mechanical influence of contractions - increasing pressure - results in dilatation of the cervix. In cases of early maturation of the cervix, this cascade of events is initiated prematurely and is irreversible so that the cervix loses its function as a closure and support structure at the lower end of the uterus.

18. Cervical ripening and dilatation asa molecular process During pregnancy the main function of the uterine cervix is to close the uterus to maintain pregnancy.This is biochemically characterized by anabolic processes such as increasing synthesis of proteins,proteoglycans, and glycoproteins within the cervical extracellular matrix. In contrast to the phase of cervical ripening in late pregnancy, cervical dilatation during parturition at term requires the rapid synthesis and action of catabolic enzymes leading mainly to collagen degradation and changes in collagen architecture. These changes together with degradation of other fundamental matrix proteins are the cause for the impressive metamorphosis of the uterine cervix during parturition. Investigations concerning the control of these processes suggest that an increased production of proinflammatory cytokines (e.g., interleukin-1�) induces a rise in the expression of endothelial adhesion molecules with subsequent extravasation and degranulation of neutrophils. Increasing concentrations of chemotactic cytokines (e.g., interleukin- 8) lead to liberation of matrix metalloproteinases by these neutrophils, which encounter an already destabilized collagenous fiber network. Concomitantly increasing interleukin- 6 concentration stimulates prostaglandin and leukotriene synthesis, causing dilatation of cervical capillaries and further inducing extravasation of neutrophils.

19. Biochemistry of cervical ripening and dilatation The biochemical mechanisms of cervical ripening and its regulation are yet not fully understood. The cervical ripening phase, which begins 4 weeks prior to the delivery (up to a cervical dilatation of 2�3 cm), is characterized by acatabolic metabolism of proteoglycans and glycosaminoglycans, mainly by a dramatic increase in the hyaluronan concentration associated with increased water uptake and by a significant reduction of collagen concentration within the extracellular matrix.These catabolic transformation processes of the cervix are regulated via cervical fibroblasts by steroid hormones, prostaglandin E2, cytokines and the NO system. The role of neutrophils and macrophages, which are accumulated in and around cervical vessels at that time, still remains unclear.The cervical dilatation during parturition has been compared to an inflammatory reaction and is characterized by migration, infiltration and degranulation of neutrophils with subsequent release of proteases and collagenases and enzymatic degradation of fundamental matrix proteins, in particular collagen.The increased synthesis of cytokines, in particular IL-1� and IL-8, and the increased expression of vascular endothelial adhesion molecules play a crucial role in these processes.

20. Tissue Ripening Factors First one step behind: In Cervical tissue there are contractile muscle cells, there are collagen and elastin fasern and there is fluid matrix. There are receptors for endocrine stimulation for estrogen and progesteron signaling pathways. This is the target for all these oral or vaginal or cervical applied tablets and gels. All these substances are potential targets for drugs: Dinoprostone PGE2 PREPIDIL Gel intracervical 3g with 0,5mg every 6h (max.3 times) CERVIDIL net fornix post, retard: 12h ex +/- Oxytocin SYNTHOCINON iv/vag 1-4mU/min Misoprostol PGE1 CYTOTEC 1/4Tabl 25� every 4h intracerv (oral) cave: hyperstimulation, prior cesarean, +/- Oxytocin Antiprogesterone+Antiglucocorticoid Mifepristone RU-486 Abortio First one step behind: In Cervical tissue there are contractile muscle cells, there are collagen and elastin fasern and there is fluid matrix. There are receptors for endocrine stimulation for estrogen and progesteron signaling pathways. This is the target for all these oral or vaginal or cervical applied tablets and gels. All these substances are potential targets for drugs: Dinoprostone PGE2 PREPIDIL Gel intracervical 3g with 0,5mg every 6h (max.3 times) CERVIDIL net fornix post, retard: 12h ex +/- Oxytocin SYNTHOCINON iv/vag 1-4mU/min Misoprostol PGE1 CYTOTEC 1/4Tabl 25� every 4h intracerv (oral) cave: hyperstimulation, prior cesarean, +/- Oxytocin Antiprogesterone+Antiglucocorticoid Mifepristone RU-486 Abortio

21. Tissue Ripening Factors But there is iduction of tissue ripening by mechanical pressure and traction, too. This leads to freisetzung of prostaglandines from membranes, of stimulation of cytokines. In toto it looks like mimikring a infammation process. This could be a explanation, why infected genital tract would lead to preterm birth. But there is iduction of tissue ripening by mechanical pressure and traction, too. This leads to freisetzung of prostaglandines from membranes, of stimulation of cytokines. In toto it looks like mimikring a infammation process. This could be a explanation, why infected genital tract would lead to preterm birth.

22. Tissue Ripening Factors Here you can see that mechanical stimulation is coexistent with hormonal, lipid based and protein based ripening factors. High pressure of twins pregnancy effects a shift toward hormonal stimulation, final in acceleration of ripening. Here you can see that mechanical stimulation is coexistent with hormonal, lipid based and protein based ripening factors. High pressure of twins pregnancy effects a shift toward hormonal stimulation, final in acceleration of ripening.

23. Medical Safety ?A stimulation for review of common practise Last slide you saw the cooperational network of the ripening factors. Application of a drug (e.g. Prostaglandine E2) into vagina or into the cervix is comarable with overexposition of just ONE ripening factor. All other factors stay at the same level. The accumulation of the drug and its metabolites at high concentration level could be reason of side effects, as for example: Excessive uterine activity, induced labor contractions, fever or heartbeat acceleration at mother and baby. Especially when a 1oo�g tablet has no lines for breaking into 4 pieces � eg. to get 25�g Prostaglandin dosis. (Recommendation: 25� every 3h, 50� every 5h, 100� every 6-12h. Be aware of potential dosis accumulation).�There is a possibility that an unacceptably high number of serious adverse events such as uterine rupture and asphyxial fetal deaths may occur if sufficient numbers are studied.(5)� Provocative PolarisationLast slide you saw the cooperational network of the ripening factors. Application of a drug (e.g. Prostaglandine E2) into vagina or into the cervix is comarable with overexposition of just ONE ripening factor. All other factors stay at the same level. The accumulation of the drug and its metabolites at high concentration level could be reason of side effects, as for example: Excessive uterine activity, induced labor contractions, fever or heartbeat acceleration at mother and baby. Especially when a 1oo�g tablet has no lines for breaking into 4 pieces � eg. to get 25�g Prostaglandin dosis. (Recommendation: 25� every 3h, 50� every 5h, 100� every 6-12h. Be aware of potential dosis accumulation).�There is a possibility that an unacceptably high number of serious adverse events such as uterine rupture and asphyxial fetal deaths may occur if sufficient numbers are studied.(5)� Provocative Polarisation

24. Common Used Drugs! NO dosing evidence ! Dinoprostone PGE2 (+/- Oxytocin iv/vag 1-4mU/min ) PREPIDIL Gel intracervical 3g with 0,5mg every 6h (max.3 times) CERVIDIL net fornix post, retard: 12h ex Misoprostol PGE1 CYTOTEC 1/4Tabl 25� every 4h intracerv (oral) cave: hyperstimulation, prior cesarean, +/- Oxytocin Antiprogesterone+Antiglucocorticoid Mifepristone RU-486 Abortio Just for survey information !Just for survey information !

25. Ripen the Cervix, Induction of labor. Mechanical methods Mechanical methods (single or double balloon catheter, osmotic acting dilators, amniotomy, digital stripping of the cervix channel ) are the oldest methods to ripen the cervix or to induce labor. Synthetic prostaglandins have,however, increasingly replaced the use of mechanical methods in industrialized countries while in developing countries these methods are still the most frequently used as they are cheap, reversible, and usually do not require fetal monitoring. The mechanical methods in use today usually employ a single- or double ballooncatheter. Compared with prostaglandins or oxytocin, catheters are equally safe and effective. Moreover, in women with unfavorable cervix, cervical ripening with a ballooncatheter seems to be more effective and associated with a lower operative delivery rate. In women with a previous cesarean delivery, the use of the intracervical balloon catheter must be considered the method of choice for maturation of the cervix, since it is safe with a uterine rupture rate similar to that associated with spontaneous labor.

26. Let�s have a look at Cook Now: Can keep your Cook Balloons their promises? Full management of ripening, with effacement and induction of dilation?Now: Can keep your Cook Balloons their promises? Full management of ripening, with effacement and induction of dilation?

27. Cook Application Step 1 Advance the Cervical Ripening Balloon through the cervix until both balloons have entered the cervical canal. Now talking about Cook: Can you keep your promises? For verification you have to put Cook into right place: Step1Now talking about Cook: Can you keep your promises? For verification you have to put Cook into right place: Step1

28. Cook Application Step 2 abut = ansto�enabut = ansto�en

29. Cook Application Step 3 The vaginal balloon is now visible outside the external cervical os and is inflated with 20 mL of saline.

30. Cook Application Step 4 Once the balloons are situated on either side of the cervix, saline is added to a maximum of 80 mL per balloon. Placement of the balloon should be timed so that it is in place no longer than 12 hours before active labor is induced.

31. The Perfect Cook

32. Cooks Reference Nr.1 Ripening and dilatation of the unfavourable cervix for induction of labour by a double balloon device: experience with 250 cases: Jack Atad MD et al. British Journal of Obstetrics and Gynaecology January 1997, Vol. 104, pp. 29-32 Objective To determine the efficacy of the double balloon device (the Atad Ripener Device) in ripening and dilatation of the unfavourable cervix for induction of labour. Methods Two hundred and fifty women with unfavourable cervices (Bishop score 5 4) underwent induction of labour with the Atad Ripener Device. Indications were pregnancy induced hypertension (n = 11 8), post-dates (n = 69), elective inductions (n = 23), other reasons including nonreassuring nonstress test, intrauterine growth retardation, previous caesarean section and diabetes mellitus (n = 40). The Atad Ripener Device was inserted into the cervix, the uterine balloon inflated in the internal os, and the cervico-vaginal balloon in the external 0s of the cervix (100 mL of normal saline to each balloon). Pressure produced by the inflated balloons caused gradual dilatation and effacement of the cervix. The Atad Ripener Device was removed 12 h after insertion, the cervix assessed again, and labour managed according to obstetrical criteria. Results The Atad Ripener Device caused an increase in the Bishop score in all subgroups with a mean change of 4.6 (from 2.0 prior to induction to 6.6 upon removal of the Atad Ripener Device; P < 0.05). The mean time interval from insertion of the Atad Ripener Device to delivery was 18.9 h, and from removal to delivery was 6-9 h. Caesarean section was performed in 39/250 patients (1 6%), and the others had a normal vaginal delivery. Conclusions 1. The double balloon device induces significant ripening and dilatation of the unfavourable cervix. 2. Induction of labour was successfully achieved following removal of the Atad Ripener Device. 3. Our caesarean section rate was low compared with rates reported for women with an unfavourable cervix induced by other methods.

33. Cooks Reference Nr.2 A Randomized Comparison of Prostaglandin E2, Oxytocin, and the Double-Balloon Device in Inducing Labor. Atad J. et al. Obstet Gynecol. 1996;87(2):223-27 The Atad Ripener Device had a significantly better success rate for cervical dilation and lower failure rate than those for PGE2 and Atad Ripener Device groups had better results than the oxytocin group in regard to Bishop score change and induction-to-delivery interval. The Atad Ripener Device may be a superior method for cervical ripening and labor induction in patients with unfavorable cervices.

34. Cooks Reference Nr.3 Ripening of the unfavorable cervix with extraamniotic catheter balloon: clinical experiences and review. Sherman et al. Obstet Gynecol Surv.1996;51(10):621-7 The effectiveness of this ripening technique and the relatively low rate of complications and side effects strongly advocates ist routine use.

35. Ultrasound for Cervix Lenght

36. Can You Follow Cooks Description out of this Powerpoint? The Cook Cervical Ripening Balloon offers a safe, simple method for cervical ripening in unfavorable cervical conditions, without the potential side effects of other ripening methods. Induction of labor in patients with unfavorable cervical conditions is a challenging obstetrical process, and may be complicated by the cervical ripening method used. Certain medical therapies such as the use of prostaglandins may lead to potentially inconvenient side effects, higher failed induction rates, and may still result in undesired cesarean section deliveries. The Cook Cervical Ripening Balloon is engineered to naturally and gradually dilate the cervix and facilitate labor induction. Ripening and dilation are accomplished by the balloons' gentle and constant pressure at the level of the cervix from both the internal and external ostia. Safely ripens and dilates the cervix without pharmaceuticals Eliminates the potential side effects of repeat medications Silicone balloons adapt to the contour of the cervical canal Easily placed and quickly removed For more information on labor management using the Cook Cervical Ripening Balloon, please refer to the Instructions for Use. accomplished: wird vollendet, wird vervollst�ndigt, wird zu Ende gebrachtaccomplished: wird vollendet, wird vervollst�ndigt, wird zu Ende gebracht

37. Mechanical or Medical RipeningSynergy or Antagonism

38. Marketingplan Compare target vs. actual performance Our position on market / marketshares Product � Competitor � Client Strategy � Realisation SWOT Tools � Trends Positioning � Profile Activities � Actions � ReActions Matrix of Success Teamwork Logistic � Timemanagement TARGETs Future Perspectives

39. Recommended Literature Part 1feel free downloading from idisk: www.floegel.info Laughon SK, Zhang J, Troendle J, Sun L, Reddy UM. Using a simplified Bishop score to predict vaginal delivery. Obstet Gynecol. Apr 2011;117(4):805-11. [Medline]. Crane JM, Hutchens D. Transvaginal sonographic measurement of cervical length to predict preterm birth in asymptomatic women at increased risk: a systematic review. Ultrasound Obstet Gynecol. May 2008;31(5):579-87. [Medline]. Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and induction of labour. Cochrane Database Syst Rev. Oct 7 2009;CD003246. [Medline]. Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. Oct 6 2010;CD000941. [Medline]. Austin SC, Sanchez-Ramos L, Adair CD. Labor induction with intravaginal misoprostol compared with the dinoprostone vaginal insert: a systematic review and metaanalysis. Am J Obstet Gynecol. Jun 2010;202(6):624.e1-9. [Medline]. ACOG Committee on Obstetric Practice. ACOG Committee Opinion No. 342: induction of labor for vaginal birth after cesarean delivery. Obstet Gynecol. Aug 2006;108(2):465-8. [Medline]. Christensen FC, Tehranifar M, Gonzalez JL, et al. Randomized trial of concurrent oxytocin with a sustained-release dinoprostone vaginal insert for labor induction at term. Am J Obstet Gynecol. Jan 2002;186(1):61-5. [Medline]. Mullin PM, House M, Paul RH, Wing DA. A comparison of vaginally administered misoprostol with extra-amniotic saline solution infusion for cervical ripening and labor induction. Am J Obstet Gynecol. Oct 2002;187(4):847-52. [Medline]. Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. Feb 2006;107(2 Pt 1):234-9. [Medline]. Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor induction: a systematic review and metaanalysis. Am J Obstet Gynecol. Nov 2010;203(5):418-29. [Medline]. Ferguson JE 2nd, Head BH, Frank FH, et al. Misoprostol versus low-dose oxytocin for cervical ripening: a prospective, randomized, double-masked trial. Am J Obstet Gynecol. Aug 2002;187(2):273-9; discussion 279-80. [Medline]. Hapangama D, Neilson JP. Mifepristone for induction of labour. Cochrane Database Syst Rev. 2009;(3):CD002865. [Medline]. Boulvain M, Stan C, and Irion O. Membrane sweeping for induction of labor. Cochrane Database Sys Rev. January 2005;25(1):[Medline]. Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. Jul 2010;116(1):121-6. [Medline]. Abdellah MS, Hussien M, Aboalhassan A. Intravaginal administration of isosorbide mononitrate and misoprostol for cervical ripening and induction of labour: a randomized controlled trial. Arch Gynecol Obstet. Jun 26 2010;[Medline]. Promsonthi P, Preechapornprasert D, Chanrachakul B. Nitric oxide donors for cervical ripening in first-trimester surgical abortion. Cochrane Database Syst Rev. 2009;(4):CD007444. [Medline]. Byers BD, Bytautiene E, Costantine MM, et al. Hyaluronidase modifies the biomechanical properties of the rat cervix and shortens the duration of labor independent of myometrial contractility. Am J Obstet Gynecol. Dec 2010;203(6):596.e1-5. [Medline]. Sanchez-Ramos L, Olivier F, Delke I, Kaunitz AM. Labor induction versus expectant management for postterm pregnancies: a systematic review with meta-analysis. Obstet Gynecol. Jun 2003;101(6):1312-8. [Medline]. ACOG Practice bulletin no. 115: Vaginal birth after previous cesarean delivery. Obstet Gynecol. Aug 2010;116(2 Pt 1):450-63. [Medline]. Mozurkewich E. 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Nitric oxide as the final metabolic mediator of cervical ripening. Hum Reprod. Feb 1998;13(2):245-8. [Medline]. Cook CM, Ellwood DA. The cervix as a predictor of preterm delivery in 'at-risk' women. Ultrasound Obstet Gynecol. Feb 2000;15(2):109-13. [Medline]. Dede FS, Haberal A, Dede H, et al. Misoprostol for cervical ripening and labor induction in pregnancies with oligohydramnios. Gynecol Obstet Invest. 2004;57(3):139-43. [Medline]. Denison FC, Calder AA, Kelly RW. The action of prostaglandin E2 on the human cervix: stimulation of interleukin 8 and inhibition of secretory leukocyte protease inhibitor. Am J Obstet Gynecol. Mar 1999;180(3 Pt 1):614-20. [Medline]. Friedman MA. Manufacturer's warning regarding unapproved uses of misoprostol. N Engl J Med. Jan 4 2001;344(1):61. [Medline]. Goldberg AB, Greenberg MB, Darney PD. Misoprostol and pregnancy. N Engl J Med. Jan 4 2001;344(1):38-47. [Medline].

40. Recommended Literature Part 2 feel free downloading from idisk: www.floegel.info Hale RW, Zinberg S. Use of misoprostol in pregnancy. N Engl J Med. Jan 4 2001;344(1):59-60. [Medline]. Hughes EG, Kelly AJ, Kavanagh J. Dinoprostone vaginal insert for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. May 2001;97(5 Suppl 1):847-55. [Medline]. Kashanian, M. Akbarian A. Baradaran H. Samiee MM. Effect of membrane sweeping at term pregnancy on duration of pregnancy and labor induction: a randomized trial. Gynecologic and Obstetric Investigation. 2006;62(1):41-44. [Medline]. Kniss DA, Iams JD. Regulation of parturition update. Endocrine and paracrine effectors of term and preterm labor. Clin Perinatol. Dec 1998;25(4):819-36, v. [Medline]. Leppert PC. Anatomy and physiology of cervical ripening. Clin Obstet Gynecol. Jun 1995;38(2):267-79. [Medline]. Levey KA, MacKenzie AP, Stephenson C, et al. Increased rates of chorioamnionitis with extra-amniotic saline infusion method of labor induction. Obstet Gynecol. Apr 2004;103(4):724-8. [Medline]. Luoma L, Herrg�rd E, Martikainen A, Ahonen T. Speech and language development of children born at < or = 32 weeks' gestation: a 5-year prospective follow-up study. Dev Med Child Neurol. Jun 1998;40(6):380-7. [Medline]. Luque EH, Mu�oz de Toro MM, Ramos JG, et al. Role of relaxin and estrogen in the control of eosinophilic invasion and collagen remodeling in rat cervical tissue at term. Biol Reprod. Oct 1998;59(4):795-800. [Medline]. Lydon-Rochelle M, Holt VL, Easterling TR, Martin DP. Risk of uterine rupture during labor among women with a prior cesarean delivery. N Engl J Med. Jul 5 2001;345(1):3-8. [Medline]. Moore, Lisa; Rayburn, William. Elective induction of labor. Clinical Obstetrics and Gynecology. September/2006;49(3):698-704. [Medline]. Nicholson WK, Frick KD, Powe NR. Economic burden of hospitalizations for preterm labor in the United States. Obstet Gynecol. Jul 2000;96(1):95-101. [Medline]. Nielsen PE, Howard BC, Hill CC, Larson PL, Holland RH, Smith PN. Comparison of elective induction of labor with favorable Bishop scores versus expectant management: a randomized clinical trial. J Matern Fetal Neonatal Med. Jul 2005;18(1):59-64. [Medline]. Norman JE, Thomson AJ, Greer IA. Cervical ripening after nitric oxide. Hum Reprod. Feb 1998;13(2):251-2. [Medline]. [Best Evidence] Nunes FP, Campos AP, Pedroso SR, Leite CF, Avillez TP, Rodrigues RD. Intravaginal glyceryl trinitrate and dinoprostone for cervical ripening and induction of labor. Am J Obstet Gynecol. Apr 2006;194(4):1022-6. [Medline]. [Best Evidence] Osman I, MacKenzie F, Norrie J, Murray HM, Greer IA, Norman JE. The "PRIM" study: a randomized comparison of prostaglandin E2 gel with the nitric oxide donor isosorbide mononitrate for cervical ripening before the induction of labor at term. 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41. A Baby for COOK Austria ?

42. The Cook Cervical Ripening BalloonPreinduction Cervical Dilation Dear Auditorium. My name is Erich, this presentation is focused on Medical Staff.Dear Auditorium. My name is Erich, this presentation is focused on Medical Staff.

43. Cook� ZervixreifungskatheterStudienerkl�rung B.Jatzko, H.Helmer

44. Cook Ballonkatheter Silikon Doppelballonkatheter Bereits zugelassenes Medizinprodukt Mechanische Zervixreifung zur Geburtsseinleitung Platzierung in den Zervikalkanal Stufenweises F�llen der Ballone mit je max. 80ml NaCl

45. Cook Ballonkatheter Mechanische Zervixreifung durch Aussch�ttung proinflammatorischer Zytokine ? Synthese k�rpereigener Prostaglandine Vorteile: Reversibel Keine systemische Komplikationen/Nebenwirkungen keine schweren Nebenwirkungen bekannt

46. Cook Ballonkatheter Einschlusskriterien: Patientinnen mit Zervix- oder beginnendem MM-Befund medizinische Indikation zur Geburtseinleitung Terminschwangerschaft Fetale Sch�dellage Einlingsschwangerschaft Alter >18 Jahre intakte Fruchtblase

47. Cook Ballonkatheter Ausschlusskriterien: Blasensprung Fetale Fehlbildungen Z.n. Uterusoperationen Pathologische Plazentation

48. Cook Ballonkatheter Durchf�hrung: Rekrutierung der Patientinnen aus der CTG Ambulanz Ausf�hrliche Aufkl�rung + Unterschreiben der Einverst�ndniserkl�rung Legen des Ballonkatheters Max. Liegedauer: 12 h Reevaluierung des Zervixbefundes Pause f�r bis zu 24h bei fehlendem Geburtsfortschritt: ? PGE2-Vaginaltablette oder Synthocinon i.v.

49. Cook Ballonkatheter Abbruchkriterien: Blasensprung Blutung Pathologisches CTG