Clinical trial NCT02098382: Dilapan-S Osmotic Dilator in Pre-induction of Labor
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Cervical Incompetence
Keywords: Cervical ripening
Lead sponsor: Medicem International CR s.r.o.
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 125
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients indicated in the centres involved in data collection for pre-induction of labor with Dilapan-S who meet all inclusion and exclusion criteria.

In the above period, the Investigator will include consecutive patients in such a manner that the numbers of those with and without a history of Caesarean section be balanced.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cervix (Bishop) score
timeFrame: Before pre-induction of labor performance and up to 24 h after pre-induction of labor
Secondary outcomes:
measure: Total duration of pre-induction
timeFrame: From Dilapan-S rods insertion up to 24 hours
measure: Number of dilators inserted
timeFrame: At the moment of Dilapan-S insertion up to 24 hours until their removal
measure: Uterine contractions
timeFrame: From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase
measure: The course of delivery (vaginally or Caesarean section)
timeFrame: From active phase of labor up to 1 day after delivery
measure: Apgar score
timeFrame: At 1st, 5th and 10th minute after delivery
measure: pH of the fetus
timeFrame: Up to 10 minutes after delivery
measure: Infection complications of mother / fetus
timeFrame: Up to 5 days from the birth
Other outcomes:
measure: Course of removal of Dilapan-S rods after pre-induction
timeFrame: At the moment of removal of Dilapan-S rods after labor pre-induction phase up to 1 day after delivery
measure: 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
timeFrame: From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase
measure: Patients´evaluation of pre-induction of labor with Dilapan-S
timeFrame: From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase
Locations:
city: Brno
country: Czech Republic
facility: Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School
Study officials:
affiliation: Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
name: Ondrej Simetka, AssProf,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic
name: Lukas Hruban, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
name: Igor Michalec, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic
name: Radovan Vlk, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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