Delivery, ObstetricDiBalNCT06506721
Comparison Between Two Medical Devices for Labor Induction After Previous C-section
A study testing Double ballon device, Cook and Hygroscopic cervix dilators, Dilapan-S in people with Delivery, Obstetric and Cesarean Section, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Obstetric, Cesarean Section, Obstetric Delivery
- What is being tested?
- Double ballon device, Cook and Hygroscopic cervix dilators, Dilapan-S
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Dec 2023to 28 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All women >= 18years old with a previous CS and an indication of labour induction, between 24-42 weeks of pregnancy.
- Modified Bishop-Score < 6
- Informed consent
Who cannot join
- More than 1 CS
- Premature rupture of membranes
- Vaginal infection
- Intrauterine fetal demise
- Twin pregnancy
- Contraindication against labour induction or vaginal delivery
Show all 21Show fewer
- Vaginal bleeding
- Simultaneous external administration of prostaglandins planned
- Placenta praevia, vasa praevia or placenta accreta spectrum
- Transverse fetal orientation
- Prolapsed umbilical cord
- Prior hysterotomy, classic uterine incision, myomectomy or any other full thickness uterine incision (except C-section)
- Pelvic structural anomaly
- Active genital herpes infection
- Invasive cervical cancer
- Abnormal fetal heart rate pattern
- Breech presentation
- Maternal heart disease
- Polyhydramnios
- Presentic part above the pelvic inlet
- Severe maternal hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Obstetrics and Gynäkologie, Inselspital
Bern, 3010
Anda P Radan, PD Dr. med., 0041/ 0316321010, Anda-Petronela.Radan@insel.ch
Mihaela M Fluri, Dr. med. univ., 0041/ 0316321010, mihaela-madalina.fluri@insel.ch
About this study
Official title: Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial
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.
Read the detailed description
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®.
- Conditions
- Delivery, Obstetric, Cesarean Section, Obstetric Delivery
- Being tested
- Double ballon device, Cook, Hygroscopic cervix dilators, Dilapan-S
- Keywords
- Trial of Labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double ballon device, CookDevice
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.
Hygroscopic cervix dilators, Dilapan-SDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Double balloon device | Active comparator | In this group of patients, the labour will be induced using the Cook double balloon device Receives: Device: Double ballon device, Cook |
| Hygroscopic cervix dilators | Active comparator | In this group of patients, the labour will be induced using the hygroscopic cervix dilators Dilapan-S Receives: Device: Hygroscopic cervix dilators, Dilapan-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours
Secondary outcomes (6)
Cesarean delivery rate
How many women will get at the end a C-section after inducing the labour
Measured: 72 hours
Neonatal outcomes
The cord arterial pH (< 7.10)
Measured: 2 hours
Neonatal outcomes
5 minutes APGAR-Score (< 7)
Measured: 2 hours
Neonatal outcomes
Transfer to the ICU
Measured: 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)
Measured: 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)
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start29 Dec 2023
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Delivery, ObstetricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open (unblinded) prospective randomized trial
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Surbek, Prof. Dr., Principal investigator, Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506721
- Sponsor's protocol ID
- 1650
- Other IDs
- 10000993, 2019-02112, CIV-21-12-038486, 2019
- Acronym
- DiBal
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16880321Menacker 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.
PubMed 17011392Greene 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.
PubMed 15598961American 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.
PubMed 24565430Martel 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.
PubMed 15943001Ravasia 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.
PubMed 11084562Grobman 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.
PubMed 17267822Saad 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.
PubMed 30790569Radan 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.
PubMed 29120029Gupta 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.
PubMed 30107363Koenigbauer 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.
PubMed 34333894Mueller 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.
PubMed 24554332Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
PubMed 26727629Christmann-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.
PubMed 26980229
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06506721
- Acronym / sponsor ID
- DiBal / 1650
- Conditions
- Delivery, Obstetric, Cesarean Section, Obstetric Delivery
- Keywords
- Trial of Labour
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Dec 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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®.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open (unblinded) prospective randomized trial
| Arm | Type | Receives |
|---|---|---|
| Double balloon device | Active comparator | Device: Double ballon device, CookIn this group of patients, the labour will be induced using the Cook double balloon device |
| Hygroscopic cervix dilators | Active comparator | Device: Hygroscopic cervix dilators, Dilapan-SIn this group of patients, the labour will be induced using the hygroscopic cervix dilators Dilapan-S |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All women >= 18years old with a previous CS and an indication of labour induction, between 24-42 weeks of pregnancy.
- Modified Bishop-Score < 6
- Informed consent
Key exclusion criteria (21 listed)
- More than 1 CS
- Premature rupture of membranes
- Vaginal infection
- Intrauterine fetal demise
- Twin pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double ballon device, CookCook 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. | Device | Double balloon device |
| Hygroscopic cervix dilators, Dilapan-SA 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. | Device | Hygroscopic cervix dilators |
Primary outcome
Induction-to-delivery interval (IDI) after induction of labour (COOK catheter or Dilapan) in women with previous CS.
Time frame: 72 hours
The time between placement of the device and delivery
6 secondary outcomes
Cesarean delivery rate
Time frame: 72 hours
Neonatal outcomes
Time frame: 2 hours
Neonatal outcomes
Time frame: 2 hours
Neonatal outcomes
Time frame: 2 hours
Maternal infection rate
Time frame: 96 hours
Patient satisfaction
Time frame: 96 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Background: PubMed 16880321American 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.
- Background: PubMed 17011392Menacker 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.
- Background: PubMed 15598961Greene 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.
- Background: PubMed 24565430American 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.
- Background: PubMed 15943001Martel 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.
- Background: PubMed 11084562Ravasia 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.
- Background: PubMed 17267822Grobman 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.
- Background: PubMed 30790569Saad 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.
- Background: PubMed 29120029Radan 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.
- Background: PubMed 30107363Gupta 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.
- Background: PubMed 34333894Koenigbauer 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.
- Results publication: PubMed 24554332Mueller 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.
- Surbek D, Rath W. Vaginale Geburt nach vorausgegangener Sectio - riskant?Link provided by the sponsor.
- Geburtseinleitung bei Zustand nach SectioLink provided by the sponsor.
- Dilapan Information for patientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Surbek, Prof. Dr. principal investigator
Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double ballon device, Cook and Hygroscopic cervix dilators, Dilapan-S in people with Delivery, Obstetric and Cesarean Section, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anda P Radan, PD Dr. med. (+41/0316321010, Anda-Petronela.Radan@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction-to-delivery interval (IDI) after induction of labour (COOK catheter or Dilapan) in women with previous CS. (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506721, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.