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Labour Onset and Length AbnormalitiesDSREGISTRYILNCT02318173

Dilapan-S/Dilasoft E-Registry in Induction of Labor

An observational study of Labour Onset and Length Abnormalities and Labor; Forced or Induced, Affecting Fetus or Newborn, run by Medicem International CR s.r.o. at 11 sites in 7 countries.

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

International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Dilapan-S
Type of treatment
Medical device
How many people
444 participants
Where
11 sitesin 7 countries
Study dates
May 2015to Dec 2016
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 the patients in whom the use of osmotic dilators Dilapan-S or Dilasoft is indicated by the Investigator after a thorough Medical examination will be included in the study unless that the patient disagree.

Who may be able to join

  • Indication for induction of labor
  • Unfavourable cervix

Who cannot join

  • Presence of overt genital tract infection

Trial locations and contacts

11 sites in 7 countries.

11 sites in 7 countries

India3 sites

  • Sri Ramachandra Medical Center

    Chennai, Tamil Nadu, 600116

  • Fernandez Hospital

    Hyderabad, Telangana, 500001

  • Guru Teg Bahadur Hospital

    New Delhi, National Capital Territory of Delhi, 110095

Other trials in India

United States2 sites

  • University of Texas Medical Branch Galveston

    Galveston, Texas, 77555

  • Bellevue Hospital

    New York, New York, 10016

Other trials in United States

Germany2 sites

  • Vivantes Klinikum im Friedrichshain

    Berlin, 10249

  • Buerger Hospital

    Frankfurt am Main, 60318

Other trials in Germany

Czechia1 site

  • Masaryk University

    Brno, 625 00

Other trials in Czechia

Russia1 site

  • Federal State Budget Institution "Research Center for Obstetrics, Gynecology and Perinatology" of the Ministry of Healthcare of Russian Federation

    Moscow, 117997

Other trials in Russia

Slovakia1 site

  • University Hospital Trnava

    Trnava, 917 75

Other trials in Slovakia

United Kingdom1 site

  • Birmingham Women´s Hospital

    Birmingham, West Midlands, B15 2TG

Other trials in United Kingdom

About this study

Official title: International Observational E-Registry on the Use of Dilapan-S / Dilasoft Osmotic Dilators for Cervical Ripening Prior to Labour Induction

International Observational E-Registry on the use of DILAPAN-S® osmotic dilator / DILASOFT® osmotic dilator for cervical ripening prior to labour induction.

Read the detailed description

International Observational E-Registry to monitor current common clinical practice of use of Dilapan-S / Dilasoft for cervical ripening and following procedures of labour induction with the main focus on the duration of induced labor procedure .

Being tested
Dilapan-S
Keywords
Cervical dilatation

What participants receive

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

  • Dilapan-SDevice

    Also called Dilasoft

    Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix

What is being measured

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

  1. Duration of Dilapan-S/Dilasoft insertion

    duration of cervical ripening

    Measured: max. up to 24 hrs; estimated average 12 hrs)

  2. Induction - delivery interval

    Overall duration of induced labor procedure

    Measured: estimated maximum up to 72 hrs

  3. Rate of vaginal deliveries within 24 hours

    Rate of vaginal deliveries achieved within 24 hours from the beginning of induced labor procedure

    Measured: up to 24 hrs

Secondary outcomes (12)

  1. Type of osmotic dilator used: Dilapan-S or Dilasoft

    Measured: up to 24 hrs; estimated average 12 hrs

  2. Number of dilators inserted

    Measured: up to 24 hrs; estimated average 12 hrs

  3. Bishop Score increase after extraction of osmotic dilators

    Measured: up to 24 hrs; estimated average 12 hrs

  4. Complications during pre-induction

    uterine contractions, uterine hypersensitivity, effect on the foetus

    Measured: up to 24 hrs; estimated average 12 hrs

  5. Agents / procedures used for induction of labour, if any

    which, total dosage

    Measured: estimated maximum up to 72 hrs

  6. % of spontaneous vaginal deliveries following immediately after pre-induction

    Measured: up to 24 hrs

  7. % of total spontaneous vaginal deliveries

    Measured: estimated maximum up to 72 hrs

  8. % of instrumented vaginal deliveries

    Measured: estimated maximum up to 72 hrs

  9. % of Caesarean sections

    Measured: estimated maximum up to 72 hrs

  10. Foetal status

    Apgar score at 0, 5 and 10 minutes after delivery, venous and arterial cord pH and base excess measurements

    Measured: 0, 5 and 10 minutes after delivery (estimated maximum up to 72 hrs)

  11. Maternal infectious complication and its relation to the use of Dilapan-S/Dilasoft

    Clinical signs of maternal infection found at patient´s examination are defined as follows:

    1. Body temperature > 37.8°C
    2. Increased pain
    3. Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection:
    4. CRP levels > 8 mg/l
    5. Leukocyte count > 18 x 109/l
    6. Positive microbiological testing

    Measured: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.

  12. Neonatal infectious complication and its relation to the use of Dilapan-S/Dilasoft

    Clinical signs of neonatal infection found at patient´s examination are defined as follows:

    1. Body temperature > 37.8°C
    2. Increased pain
    3. Other overt clinical signs of infection e.g. vaginal discharge Laboratory test results that need to be correlated with clinical signs of infection:
    4. CRP levels > 8 mg/l
    5. Leukocyte count > 18 x 109/l
    6. Positive microbiological testing

    Measured: up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.

Timeline

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

  1. First posted17 Dec 2014 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
Case only
Time perspective
Prospective
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318173
Sponsor's protocol ID
DIS-2014-009
Acronym
DSREGISTRYIL
Status last verified
May 2017
First submitted
9 Dec 2014
Last updated
19 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Sanchez-Ramos L. Induction of labor. Obstet Gynecol Clin North Am. 2005 Jun;32(2):181-200, viii. doi: 10.1016/j.ogc.2004.12.004.

    PubMed 15899354

  • Tenore JL. Methods for cervical ripening and induction of labor. Am Fam Physician. 2003 May 15;67(10):2123-8.

    PubMed 12776961

  • Ten Eikelder ML, Neervoort F, Oude Rengerink K, van Baaren GJ, Jozwiak M, de Leeuw JW, de Graaf I, van Pampus MG, Franssen M, Oudijk M, van der Salm P, Woiski M, Pernet PJ, Feitsma AH, van Vliet H, Porath M, Roumen F, van Beek E, Versendaal H, Heres M, Mol BW, Bloemenkamp KW. Induction of labour with a Foley catheter or oral misoprostol at term: the PROBAAT-II study, a multicentre randomised controlled trial. BMC Pregnancy Childbirth. 2013 Mar 19;13:67. doi: 10.1186/1471-2393-13-67.

    PubMed 23506128

  • Jozwiak M, ten Eikelder M, Oude Rengerink K, de Groot C, Feitsma H, Spaanderman M, van Pampus M, de Leeuw JW, Mol BW, Bloemenkamp K; PROBAAT Study Group. Foley catheter versus vaginal misoprostol: randomized controlled trial (PROBAAT-M study) and systematic review and meta-analysis of literature. Am J Perinatol. 2014 Feb;31(2):145-56. doi: 10.1055/s-0033-1341573. Epub 2013 Apr 5.

    PubMed 23564065

  • Sciscione AC, McCullough H, Manley JS, Shlossman PA, Pollock M, Colmorgen GH. A prospective, randomized comparison of Foley catheter insertion versus intracervical prostaglandin E2 gel for preinduction cervical ripening. Am J Obstet Gynecol. 1999 Jan;180(1 Pt 1):55-60. doi: 10.1016/s0002-9378(99)70149-3.

    PubMed 9914578

  • Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.

    PubMed 22704766

  • Suffecool K, Rosenn BM, Kam S, Mushi J, Foroutan J, Herrera K. Labor induction in nulliparous women with an unfavorable cervix: double balloon catheter versus dinoprostone. J Perinat Med. 2014 Mar;42(2):213-8. doi: 10.1515/jpm-2013-0152.

    PubMed 24096438

  • Lichtenberg ES. Complications of osmotic dilators. Obstet Gynecol Surv. 2004 Jul;59(7):528-36. doi: 10.1097/00006254-200407000-00022.

    PubMed 15199271

  • Chua S, Arulkumaran S, Vanaja K, Ratnam SS. Preinduction cervical ripening: prostaglandin E2 gel vs hygroscopic mechanical dilator. J Obstet Gynaecol Res. 1997 Apr;23(2):171-7. doi: 10.1111/j.1447-0756.1997.tb00828.x.

    PubMed 9158305

  • Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.

    PubMed 30107363

Questions about this trial

What is this clinical trial studying?

An observational study of Labour Onset and Length Abnormalities and Labor; Forced or Induced, Affecting Fetus or Newborn, run by Medicem International CR s.r.o. at 11 sites in 7 countries.

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 2 inclusion and 1 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in India, United States, Germany, Czechia, Russia and 2 more countries. 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?

Duration of Dilapan-S/Dilasoft insertion (time frame: max. up to 24 hrs; estimated average 12 hrs)). The study lists 3 primary outcomes in all. 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 NCT02318173, which also lists 10 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 19 May 2017.

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