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.
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.
Study Type
OBSERVATIONAL
Enrollment
125
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School
Brno, Czechia
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.
Time frame: Before pre-induction of labor performance and up to 24 h after pre-induction of labor
Total duration of pre-induction
To compare these outcomes in patients with and without a history of Caesarean section.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At 1st, 5th and 10th minute after delivery
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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.
Time frame: Up to 10 minutes after delivery
Infection complications of mother / fetus
Clinical signs of infection are defined as follows: 1. CRP levels \> 8 mg/l 2. Leukocyte count \> 18 x 109/l 3. Body temperature \> 37.5°C
Time frame: Up to 5 days from the birth