Dilapan-S Osmotic Dilator in Pre-induction of Labor
- Conditions
- Uterine Cervical Incompetence
- Interventions
- Device: Dilapan-S
- Registration Number
- NCT02098382
- Lead Sponsor
- Medicem International CR s.r.o.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 125
- Single pregnancy
- Pregnancy more than 36 weeks
- Vertex presentation of the fetus
- Cervix Score less than 4 points
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dilapan-S Dilapan-S 125 Patients with / without caesarean section in their medical history
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Apgar score At 1st, 5th and 10th minute after delivery To compare these results in patients with/without Caesarean 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.
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).
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
Trial Locations
- Locations (1)
Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School
🇨🇿Brno, Czech Republic