Dilapan-S Osmotic Dilator in Pre-induction of Labor

July 28, 2015 updated by: Medicem International CR s.r.o.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dilapan-S
125 Patients with / without caesarean section in their medical history
Device: Dilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Other Names:
  • synthetic osmotic dilator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervix (Bishop) score
Time Frame: 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.
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
Time Frame: From Dilapan-S rods insertion up to 24 hours
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
Time Frame: 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.
At the moment of Dilapan-S insertion up to 24 hours until their removal
Uterine contractions
Time Frame: 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).
From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase
The course of delivery (vaginally or Caesarean section)
Time Frame: 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.
From active phase of labor up to 1 day after delivery
Apgar score
Time Frame: At 1st, 5th and 10th minute after delivery
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
Time Frame: 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.
Up to 10 minutes after delivery
Infection complications of mother / fetus
Time Frame: 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
Up to 5 days from the birth

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of removal of Dilapan-S rods after pre-induction
Time Frame: 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.
At the moment of removal of Dilapan-S rods after labor pre-induction phase up to 1 day after delivery
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
Time Frame: From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase
From Dilapan-S rods insertion up to 24 h of duration of labor pre-induction phase
Patients´evaluation of pre-induction of labor with Dilapan-S
Time Frame: 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
From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medicem International CR s.r.o.

Investigators

  • Principal Investigator: Ondrej Simetka, AssProf,PhD, Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
  • Principal Investigator: Lukas Hruban, M.D., Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic
  • Principal Investigator: Igor Michalec, M.D., Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
  • Principal Investigator: Radovan Vlk, M.D., Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 28, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIS2013-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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