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| ID | Type | Description | Link |
|---|---|---|---|
| 10000993 | Other Identifier | Swissmedic | |
| 2019-02112 | Other Identifier | Cantonal Ethics Committee of Bern | |
| CIV-21-12-038486 | Other Identifier | EUDAMED |
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The objective of the study ist to compare the Dilapan-S and the Cook Ballon device for the mechanical induction of labour in women with a previous C-section. There is currently lack of data regarding this comparison of the two methods for mechanical labour induction in this patient collective. Any method used for labour induction is therefore off-label. The primary outcome is the time between placement of the device and delivery. Ad secondary outcomes are among others the cesarean delivery rate and patient satisfaction with the induction method.
The cesarean section (CS) rate is increasing worldwide, with previous CS being an important factor contributing to this trend. The investigators think that VBAC may be safe, provided a careful selection of the patients is performed. The individual birth management is particularly important if labour has to be induced, as in case of approximately 25% of women attempting VBAC. Counselling patients about labour induction can be challenging, as they should be offered not only a safe, but also an effective method. Labor induction can be achieved by using several approaches: administration of drugs, which induce uterine contractions, such as prostaglandins or oxytocin, performing an amniotomy, or using mechanical methods. In Switzerland and implicitly in the investigators' institution, PGE after CS are rarely employed in carefully selected cases. Oxytocin administration after performing amniotomy is considered to be a safe method, but may be less effective with an unfavorable BISHOP score (<6).
An possible alternative in case of unripe cervix is induction of labour by use of mechanical methods: balloon catheters and laminaria stents. The investigators currently use the double balloon catheter device (Cook Inc) for this purpose. This device is inserted transcervically and both ballons are inflated with sterile 0.9% saline solution. The catheter remains in place until spontaneously expelled or until start of active labour. If neither happens, it will be removed after 12 hours, followed by oxytocin administration and amniotomy.
Recently, an alternative method for mechanical induction is gaining increased attention: the use of hygroscopic cervical dilators. The method seems to be equally effective and safe as directly compared to a single device catheter in a low risk population of women without uterine scar. When used in patients with previous cesarean section, the rate of spontaneous labour seems to resemble existent data for induction with balloon catheter, this including the investigators' collective.
One of the advantages of Dilapan-S® could be the lack of vaginal protrusion and the fact that it does not have to be fixated under tension. Women seem to feel more mobile with Dilapan®, the perception of relaxation moments between contractions as well as sleep periods during the induction seem to be improved with Dilapan®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double balloon device | Active Comparator | In this group of patients, the labour will be induced using the Cook double balloon device |
|
| Hygroscopic cervix dilators | Active Comparator | In this group of patients, the labour will be induced using the hygroscopic cervix dilators Dilapan-S |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double ballon device, Cook | Device | Cook double balloon will be introduced transcervically. The double balloon will be inflated with sterile 0-9% saline solution (maximum 80 ml in each balloon of the double device), then the catheter will be fixed with a tape at the women's thigh without traction. The catheter will remain in place until spontaneously expelled or start of active labour. If neither happens, the device will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Induction-to-delivery interval (IDI) after induction of labour (COOK catheter or Dilapan) in women with previous CS. | The time between placement of the device and delivery | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean delivery rate | How many women will get at the end a C-section after inducing the labour | 72 hours |
| Neonatal outcomes | The cord arterial pH (< 7.10) |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anda P Radan, PD Dr. med. | Contact | +41/0316321010 | Anda-Petronela.Radan@insel.ch | |
| Mihaela M Fluri, Dr. med.univ. | Contact | +41/0316321010 | mihaela-madalina.fluri@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Surbek, Prof. Dr. | Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Obstetrics and Gynäkologie, Inselspital | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16880321 | Background | American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG Committee Opinion No. 342: induction of labor for vaginal birth after cesarean delivery. Obstet Gynecol. 2006 Aug;108(2):465-8. doi: 10.1097/00006250-200608000-00045. | |
| 17011392 | Background | Menacker F, Declercq E, Macdorman MF. Cesarean delivery: background, trends, and epidemiology. Semin Perinatol. 2006 Oct;30(5):235-41. doi: 10.1053/j.semperi.2006.07.002. |
| Label | URL |
|---|---|
| Surbek D, Rath W. Vaginale Geburt nach vorausgegangener Sectio - riskant? | View source |
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Open (unblinded) prospective randomized trial
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due to nature of the induction method, blinding of women an/ or doctors is considered non-feasible
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| Hygroscopic cervix dilators, Dilapan-S | Device | A maximum number of 5 hygroscopic cervical dilator rods will be inserted transcervically, after humidification with sterile 0.9% saline solution. They will be fixed in this position by inserting a humidified compress into the vagina. They will remain in place until spontaneously expelled or until start of active labour. In neither happens, the devices will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed. |
|
| 2 hours |
| Neonatal outcomes | 5 minutes APGAR-Score (< 7) | 2 hours |
| Neonatal outcomes | Transfer to the ICU | 2 hours |
| Maternal infection rate | To asses the maternal infection status the investigators use the temperature (fever >38.0°), Leucocytosis (> 16.000 G/l), CRP (> 50) | 96 hours |
| Patient satisfaction | All participant will receive a questionnaire after birth regarding the time from induction initiation until active phase of labour, covering questions such as convenience of the induction method (multiplicity of vaginal manipulation, comfort and pain experience) | 96 hours |
| 15598961 | Background | Greene MF. Vaginal birth after cesarean revisited. N Engl J Med. 2004 Dec 16;351(25):2647-9. doi: 10.1056/NEJMe048277. Epub 2004 Dec 14. No abstract available. |
| 24565430 | Background | American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026. |
| 15943001 | Background | Martel MJ, MacKinnon CJ; Clinical Practice Obstetrics Committee, Society of Obstetricians and Gynaecologists of Canada. Guidelines for vaginal birth after previous Caesarean birth. J Obstet Gynaecol Can. 2005 Feb;27(2):164-88. doi: 10.1016/s1701-2163(16)30188-8. English, French. |
| 11084562 | Background | Ravasia DJ, Wood SL, Pollard JK. Uterine rupture during induced trial of labor among women with previous cesarean delivery. Am J Obstet Gynecol. 2000 Nov;183(5):1176-9. doi: 10.1067/mob.2000.109037. |
| 17267822 | Background | Grobman WA, Gilbert S, Landon MB, Spong CY, Leveno KJ, Rouse DJ, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM. Outcomes of induction of labor after one prior cesarean. Obstet Gynecol. 2007 Feb;109(2 Pt 1):262-9. doi: 10.1097/01.AOG.0000254169.49346.e9. |
| 30790569 | Background | Saad AF, Villarreal J, Eid J, Spencer N, Ellis V, Hankins GD, Saade GR. A randomized controlled trial of Dilapan-S vs Foley balloon for preinduction cervical ripening (DILAFOL trial). Am J Obstet Gynecol. 2019 Mar;220(3):275.e1-275.e9. doi: 10.1016/j.ajog.2019.01.008. Epub 2019 Feb 18. |
| 29120029 | Background | Radan AP, Amylidi-Mohr S, Mosimann B, Simillion C, Raio L, Mueller M, Surbek D. Safety and effectiveness of labour induction after caesarean section using balloon catheter or oxytocin. Swiss Med Wkly. 2017 Nov 8;147:w14532. doi: 10.4414/smw.2017.14532. eCollection 2017. |
| 30107363 | Background | Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3. |
| 34333894 | Background | Koenigbauer JT, Schalinski E, Jarchau U, Gauger U, Brandt K, Klaucke S, Scharf JP, Rath W, Hellmeyer L. Cervical ripening after cesarean section: a prospective dual center study comparing a mechanical osmotic dilator vs. prostaglandin E2. J Perinat Med. 2021 Aug 2;49(7):797-805. doi: 10.1515/jpm-2021-0157. Print 2021 Sep 27. |
| 24554332 | Result | Mueller M, Kolly L, Bauman M, Imboden S, Surbek D. Analysis of caesarean section rates over time in a single Swiss centre using a ten-group classification system. Swiss Med Wkly. 2014 Feb 19;144:w13921. doi: 10.4414/smw.2014.13921. |
| 26727629 | Result | Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64. |
| 26980229 | Result | Christmann-Schmid C, Raio L, Scheibner K, Muller M, Surbek D. Back to "once a caesarean: always a caesarean"? A trend analysis in Switzerland. Arch Gynecol Obstet. 2016 Nov;294(5):905-910. doi: 10.1007/s00404-016-4055-4. Epub 2016 Mar 15. |
| Geburtseinleitung bei Zustand nach Sectio | View source |
| Dilapan Information for patients | View source |