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Abortion, InducedDSREGISTRYIANCT02318212

Dilapan-S / Dilasoft E-Registry in Induced Abortion

An observational study of Abortion, Induced, run by Medicem International CR s.r.o..

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 osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Abortion, Induced
What is being tested?
Dilapan-S
Type of treatment
Medical device
How many people
439 participants
Where
No sites listed yet
Study dates
Mar 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 patients indicated for cervical priming with Dilapan-S or Dilasoft prior to induced abortion and meet all inclusion and exclusion criteria in centres involved in data collection.

Who may be able to join

  • Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation
  • Patients who are capable of giving consent and sign the form
  • Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)

Who cannot join

  • Clinical signs of uterine, vaginal or vulvar infection
  • Acute bleeding

About this study

Official title: International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion

International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.

Read the detailed description

International, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of Dilapan-S or Dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.

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 or Dilasoft for cervical priming prior to induced abortion

What is being measured

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

  1. Number of inserted osmotic dilators

    Measured: max. up to 24 hrs; estimated average 6 hrs

  2. Total time taken for cervical priming with Dilapan-S/Dilasoft

    Duration of leaving osmotic dilators in situ

    Measured: max. up to 24 hrs; estimated average 6 hrs

Secondary outcomes (9)

  1. Type of synthetic osmotic dilator used

    Dilapan-S or Dilasoft

    Measured: max. up to 24 hrs; estimated average 6 hrs

  2. Complications during cervical priming

    pre-operative bleeding, fever, pain, nausea, vomiting, diarrhoea, premature passage of foetal or chorionic tissue

    Measured: up to 24 hrs; estimated average 6 hrs

  3. Other observed undesirable effects uf use of synthetic osmotic dilators

    Measured: up to 24 hrs; estimated average 6 hrs

  4. Need of additional mechanical dilation

    In cases, when surgical abortion is performed

    Measured: up to 10 minutes after osmotic dilators extraction

  5. Surgical operative time

    Period from speculum insertion in to speculum extraction out

    Measured: estimated max. up to 10 min, estimated average 8 min.

  6. Initiation-to-delivery time

    In case of medical abortion

    Measured: hrs

  7. Induction-to-delivery time

    In case of medical abortion

    Measured: up to 72 hrs; estimated average 48 hrs

  8. Complications related to induced abortion procedure

    Measured: up to 24 hrs; estimated average 12 hrs

  9. Infectious complication and its relation to the use of Dilapan-S/Dilasoft

    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 startMar 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
439 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02318212
Sponsor's protocol ID
DIS-2014-010
Acronym
DSREGISTRYIA
Status last verified
May 2017
First submitted
9 Dec 2014
Last updated
19 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • 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

  • Newmann S, Dalve-Endres A, Drey EA; Society of Family Planning. Clinical guidelines. Cervical preparation for surgical abortion from 20 to 24 weeks' gestation. Contraception. 2008 Apr;77(4):308-14. doi: 10.1016/j.contraception.2008.01.004. Epub 2008 Mar 4.

    PubMed 18342657

  • Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9.

    PubMed 6133988

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

    PubMed 15199271

  • 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

  • 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

  • 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

  • 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

  • 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

  • Poon LC, Parsons J. Audit of the effectiveness of cervical preparation with Dilapan prior to late second-trimester (20-24 weeks) surgical termination of pregnancy. BJOG. 2007 Apr;114(4):485-8. doi: 10.1111/j.1471-0528.2006.01257.x. Epub 2007 Feb 19.

    PubMed 17309543

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Abortion, Induced, run by Medicem International CR s.r.o..

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 3 inclusion and 2 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.

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?

Number of inserted osmotic dilators (time frame: max. up to 24 hrs; estimated average 6 hrs). The study lists 2 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 NCT02318212, which also lists 12 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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