Comparison Between Two Medical Devices for Labor Induction After Previous C-section

NCT06506721 | Recruiting DMC

• 4 other identifiers: 1650100009932019-02112CIV-21-12-038486
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Delivery, Obstetric; Cesarean Section; Obstetric Delivery

Keywords

Trial of Labour

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Cesarean delivery rate

  72 hours

• Neonatal outcomes

  2 hours

• Neonatal outcomes

  2 hours

• Neonatal outcomes

  2 hours

• Maternal infection rate

  96 hours

Study Arms (2)

Double balloon device

ACTIVE COMPARATOR

In this group of patients, the labour will be induced using the Cook double balloon device

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

Device: Hygroscopic cervix dilators, Dilapan-S

Interventions

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.

Double balloon device

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.

Hygroscopic cervix dilators

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• More than 1 CS
• Premature rupture of membranes
• Vaginal infection
• Intrauterine fetal demise
• Twin pregnancy
• Contraindication against labour induction or vaginal delivery
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital of Obstetrics and Gynäkologie, Inselspital

Bern, 3010, Switzerland

RECRUITING

Related Publications (14)

• 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.

  PMID: 16880321 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.

  PMID: 17011392 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.

  PMID: 15598961 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.

  PMID: 24565430 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.

  PMID: 15943001 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.

  PMID: 11084562 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.

  PMID: 17267822 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.

  PMID: 30790569 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.

  PMID: 29120029 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.

  PMID: 30107363 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.

  PMID: 34333894 BACKGROUND

• 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.

  PMID: 24554332 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.

  PMID: 26727629 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.

  PMID: 26980229 RESULT

Related Links

• Surbek D, Rath W. Vaginale Geburt nach vorausgegangener Sectio - riskant?
• Geburtseinleitung bei Zustand nach Sectio
• Dilapan Information for patients

Study Officials

• Daniel Surbek, Prof. Dr.

  Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: due to nature of the induction method, blinding of women an/ or doctors is considered non-feasible
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open (unblinded) prospective randomized trial

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 17, 2024
• Study Start: December 29, 2023
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)