Dilapan-S Osmotic Dilator in Pre-induction of Labor

Study Overview
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Brief Summary
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Non-interventional prospective data collection designed to evaluate clinical outcome on the efficacy of the use of Dilapan-S in the indication of labor pre-induction in women with/without a history of Caesarean section. The evaluation will be based on prospective data collection in at least four obstetrics centers in the Czech Republic.

Detailed Description
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Nowadays there is a rising need for non-pharmacological cervical ripening methods as the use of prostaglandins is frequently limited by various contraindications. Dilapan-S is a hygroscopic uterine neck dilator. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of Dilapan-S sticks which subsequently exert radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results not only in its mechanical dilatation but pressure on endocervical structures also stimulates the production of endogenous prostaglandins, which promote cervical ripening through its collagenolytic action. Although Dilapan-S is widely used in labor pre-induction, published study data comparing its clinical efficacy and safety in females with/without caesarean section in medical history are lacking.

Official Title
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Prospective Collection of Data About the Use of the Dilapan-S Osmotic Dilator in Pre-induction of Labor in Women With/Without Caesarean Section in Their History

Conditions
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Uterine Cervical Incompetence

Intervention / Treatment
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* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single pregnancy Pregnancy more than 36 weeks Vertex presentation of the fetus Cervix Score less than 4 points Exclusion Criteria: Contraindication to vaginal delivery Pathological fetal station States after uterine body surgery - except for Caesarean section Clinical signs of uterine, vaginal or vulvar infection Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dilapan-S<br>125 Patients with / without caesarean section in their medical history | Device: Dilapan-S<br>* Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction<br>* Other names: synthetic osmotic dilator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervix (Bishop) score | To evaluate, based on the value obtained in the Cervix Score, the efficacy of use of the Dilapan-S device in the indication labor pre-induction, and to compare outcomes in patients with/without a history of Caesarean section. | Before pre-induction of labor performance and up to 24 h after pre-induction of labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of pre-induction | To compare these outcomes in patients with and without a history of Caesarean section. | From Dilapan-S rods insertion up to 24 hours | 
| Number of dilators inserted | Expected the insertion from 2 to 5 Dilapan-S rods. To compare these results in patients with/without Cesarean section in their medical history. | At the moment of Dilapan-S insertion up to 24 hours until their removal | 
| Uterine contractions | To compare these results in patients with/without Caesearean section in their medical history. Uterine hypertonus is diagnosed, when the number of uterine contractions is higher than 5 within 10 minutes (during pre-induction). | From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase | 
| The course of delivery (vaginally or Caesarean section) | To compare the rate of vaginal delivery/Caesarean sections in patients with/without Caesarean section in their medical history. | From active phase of labor up to 1 day after delivery | 
| Apgar score | To compare these results in patients with/without Caesarean section in their medical history. | At 1st, 5th and 10th minute after delivery | 
| pH of the fetus | To compare the results in patients with/without caesarean section in their medical history. The rate of ceses with pH below 7,1. | Up to 10 minutes after delivery | 
| Infection complications of mother / fetus | Clinical signs of infection are defined as follows: CRP levels > 8 mg/l Leukocyte count > 18 x 109/l Body temperature > 37.5°C | Up to 5 days from the birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical ripening