Uterine Cervical Incompetence
Conditions
Keywords
Cervical ripening
Brief summary
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
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.
Interventions
DEVICEDilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Sponsors
Medicem International CR s.r.o.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervix (Bishop) score | Before pre-induction of labor performance and up to 24 h after pre-induction of labor | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine contractions | From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase | 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). |
| Apgar score | At 1st, 5th and 10th minute after delivery | To compare these results in patients with/without Caesarean section in their medical history. |
| pH of the fetus | Up to 10 minutes after delivery | To compare the results in patients with/without caesarean section in their medical history. The rate of ceses with pH below 7,1. |
| Infection complications of mother / fetus | Up to 5 days from the birth | 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 |
| Total duration of pre-induction | From Dilapan-S rods insertion up to 24 hours | To compare these outcomes in patients with and without a history of Caesarean section. |
| Number of dilators inserted | At the moment of Dilapan-S insertion up to 24 hours until their removal | Expected the insertion from 2 to 5 Dilapan-S rods. To compare these results in patients with/without Cesarean section in their medical history. |
| The course of delivery (vaginally or Caesarean section) | From active phase of labor up to 1 day after delivery | To compare the rate of vaginal delivery/Caesarean sections in patients with/without Caesarean section in their medical history. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients´evaluation of pre-induction of labor with Dilapan-S | From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase | Subjective satisfaction Pain experienced during Dilapan-S insertion and pre-induction phase Quality of relax and sleep Frequency and intensity of uterine contractions during pre-induction |
| Course of removal of Dilapan-S rods after pre-induction | At the moment of removal of Dilapan-S rods after labor pre-induction phase up to 1 day after delivery | The evaluation of the course of removal of Dilapan-S after termination of preinduction by physician as very easy, easy, standard, with some complications or very complicated. |
| Occurance of complication of rupture of fetal sac due to the use of Dilapan-S or other complications related to the use of Dilapan-S | From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase | — |
Countries
Czechia
Outcome results
None listed