Comparison Between Two Medical Devices for Labor Induction After Previous C-section
Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial
Insel Gruppe AG, University Hospital Bern
137 participants
Dec 29, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria21
- 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
- Abnormal fetal heart rate pattern
- Breech presentation
- Maternal heart disease
- Polyhydramnios
- Presentic part above the pelvic inlet
- Severe maternal hypertension
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Interventions
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.
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.
Locations(1)
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NCT06506721