NCT02098382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

July 29, 2015

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 10, 2014

Last Update Submit

July 28, 2015

Conditions

Uterine Cervical Incompetence

Keywords

Cervical ripening

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

  • Total duration of pre-induction

    From Dilapan-S rods insertion up to 24 hours

  • Number of dilators inserted

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

  • Uterine contractions

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

  • The course of delivery (vaginally or Caesarean section)

    From active phase of labor up to 1 day after delivery

  • Apgar score

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

  • +2 more secondary outcomes

Other Outcomes (3)

  • Course of removal of Dilapan-S rods after pre-induction

    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

    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

    From Dilapan-S insertion up to 24 h of duration of labor pre-induction phase

Study Arms (1)

Dilapan-S

125 Patients with / without caesarean section in their medical history

Device: Dilapan-S

Interventions

Dilapan-SDEVICE

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

Also known as: synthetic osmotic dilator
Dilapan-S

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Brno, 625 00, Czechia

Location

Related Publications (13)

  • 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.

    PMID: 14645181BACKGROUND

  • 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.

    PMID: 17980952BACKGROUND

  • 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.

    PMID: 17656184BACKGROUND

  • 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.

    PMID: 19126319BACKGROUND

  • 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.

    PMID: 21570547BACKGROUND

  • 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.

    PMID: 22114527BACKGROUND

  • 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.

    PMID: 22898362BACKGROUND

  • 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.

    PMID: 24331860BACKGROUND

  • 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.

    PMID: 23743471BACKGROUND

  • 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.

    PMID: 22682721BACKGROUND

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

    PMID: 9172116BACKGROUND

  • 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.

    PMID: 24402587BACKGROUND

  • 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.

    PMID: 9650373RESULT

MeSH Terms

Conditions

Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 28, 2014

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2014

Last Updated

July 29, 2015

Record last verified: 2014-03

Locations

CZ(1)