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Uterine Cervical IncompetenceNCT02098382

Dilapan-S Osmotic Dilator in Pre-induction of Labor

An observational study of Uterine Cervical Incompetence, run by Medicem International CR s.r.o. at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Uterine Cervical Incompetence
What is being tested?
Dilapan-S
Type of treatment
Medical device
How many people
125 participants
Where
1 siteCzechia
Study dates
May 2013to Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • Single pregnancy
  • Pregnancy more than 36 weeks
  • Vertex presentation of the fetus
  • Cervix Score less than 4 points

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School

    Brno, 625 00

Other trials in Czechia

About this study

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

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.

Read the 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.

Being tested
Dilapan-S
Keywords
Cervical ripening
Medical subject headings
Uterine Cervical Incompetence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dilapan-SDevice

    Also called synthetic osmotic dilator

    Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction

Study groups in NCT02098382
Study groupRoleWhat they receive
Dilapan-S125 Patients with / without caesarean section in their medical history
Receives: Device: Dilapan-S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before pre-induction of labor performance and up to 24 h after pre-induction of labor

Secondary outcomes (7)

  1. Total duration of pre-induction

    To compare these outcomes in patients with and without a history of Caesarean section.

    Measured: From Dilapan-S rods insertion up to 24 hours

  2. 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.

    Measured: At the moment of Dilapan-S insertion up to 24 hours until their removal

  3. 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).

    Measured: From Dilapan-S rods insertion up to 24 h during pre-induction of labor phase

  4. 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.

    Measured: From active phase of labor up to 1 day after delivery

  5. Apgar score

    To compare these results in patients with/without Caesarean section in their medical history.

    Measured: At 1st, 5th and 10th minute after delivery

  6. 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.

    Measured: Up to 10 minutes after delivery

  7. 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

    Measured: Up to 5 days from the birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2014 (estimated)
  2. Study startMay 2013
  3. Primary completionOct 2013
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098382
Sponsor's protocol ID
DIS2013-002
Status last verified
Mar 2014
First submitted
10 Mar 2014
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Serhal P, Ranieri DM, Khadum I, Wakim RA. Cervical dilatation with hygroscopic rods prior to ovarian stimulation facilitates embryo transfer. Hum Reprod. 2003 Dec;18(12):2618-20. doi: 10.1093/humrep/deg477.

    PubMed 14645181

  • Chen FC, Bergann A, Krosse J, Merholz A, David M. Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan-S for cervical ripening before first trimester curettage. Eur J Obstet Gynecol Reprod Biol. 2008 Jun;138(2):176-9. doi: 10.1016/j.ejogrb.2007.09.009. Epub 2007 Nov 5.

    PubMed 17980952

  • Allen RH, Goldberg AB; Board of Society of Family Planning. Cervical dilation before first-trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception. 2007 Aug;76(2):139-56. doi: 10.1016/j.contraception.2007.05.001. Epub 2007 Jul 10.

    PubMed 17656184

  • Samuel MI, Parsons JH. Hygroscopic dilator (Dilapan-S) and misoprostol combination for the early first-trimester termination of pregnancy: a pilot study. J Fam Plann Reprod Health Care. 2009 Jan;35(1):45-7. doi: 10.1783/147118909787072234.

    PubMed 19126319

  • Wilson LC, Meyn LA, Creinin MD. Cervical preparation for surgical abortion between 12 and 18 weeks of gestation using vaginal misoprostol and Dilapan-S. Contraception. 2011 Jun;83(6):511-6. doi: 10.1016/j.contraception.2010.10.004. Epub 2010 Dec 3.

    PubMed 21570547

  • Chambers DG, Willcourt RJ, Laver AR, Baird JK, Herbert WY. Comparison of Dilapan-S and laminaria for cervical priming before surgical pregnancy termination at 17-22 weeks' gestation. Int J Womens Health. 2011;3:347-52. doi: 10.2147/IJWH.S25551. Epub 2011 Oct 20.

    PubMed 22114527

  • Lyus R, Lohr PA, Taylor J, Morroni C. Outcomes with same-day cervical preparation with Dilapan-S osmotic dilators and vaginal misoprostol before dilatation and evacuation at 18 to 21+6 weeks' gestation. Contraception. 2013 Jan;87(1):71-5. doi: 10.1016/j.contraception.2012.07.006. Epub 2012 Aug 13.

    PubMed 22898362

  • Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.

    PubMed 24331860

  • Bartz D, Maurer R, Allen RH, Fortin J, Kuang B, Goldberg AB. Buccal misoprostol compared with synthetic osmotic cervical dilator before surgical abortion: a randomized controlled trial. Obstet Gynecol. 2013 Jul;122(1):57-63. doi: 10.1097/AOG.0b013e3182983889.

    PubMed 23743471

  • Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6.

    PubMed 22682721

  • Borgatta L, Lopatinsky I, Shaw FM. Overcoming unsatisfactory colposcopy. Use of osmotic dilators. J Reprod Med. 1997 May;42(5):271-5.

    PubMed 9172116

  • Newmann SJ, Sokoloff A, Tharyil M, Illangasekare T, Steinauer JE, Drey EA. Same-day synthetic osmotic dilators compared with overnight laminaria before abortion at 14-18 weeks of gestation: a randomized controlled trial. Obstet Gynecol. 2014 Feb;123(2 Pt 1):271-278. doi: 10.1097/AOG.0000000000000080.

    PubMed 24402587

  • Roztocil A, Pilka L, Jelinek J, Koudelka M, Miklica J. A comparison of three preinduction cervical priming methods: prostaglandin E2 gel, Dilapan S rods and Estradiol gel. Ceska Gynekol. 1998 Feb;63(1):3-9.

    PubMed 9650373

Questions about this trial

What is this clinical trial studying?

An observational study of Uterine Cervical Incompetence, run by Medicem International CR s.r.o. at 1 site in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cervix (Bishop) score (time frame: Before pre-induction of labor performance and up to 24 h after pre-induction of labor). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098382, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.

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