Health TrialsbyHealthPanel

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

ConditionsDelivery, ObstetricCesarean SectionObstetric Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorInsel Gruppe AG, University Hospital Bern

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

More than 1 CS

Premature rupture of membranes

Vaginal infection

Intrauterine fetal demise

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

137 Participants
are divided into 2 treatment groups
Group A: Double balloon deviceActive comparator 1 intervention
Group B: Hygroscopic cervix dilatorsActive comparator 1 intervention

Trial outcomes

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

Time frame
72 hours

Secondary outcomes

1

Cesarean delivery rate

How many women will get at the end a C-section after inducing the labour

Time frame
72 hours
2

Neonatal outcomes

The cord arterial pH (\< 7.10)

Time frame
2 hours
3

Neonatal outcomes

5 minutes APGAR-Score (\< 7)

Time frame
2 hours
4

Neonatal outcomes

Transfer to the ICU

Time frame
2 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Source ClinicalTrials.gov
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