Dilapan-S Osmotic Dilator in Pre-induction of Labor

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2013

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.

Interventions

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

Arms, Groups and Cohorts

  • Dilapan-S
    • 125 Patients with / without caesarean section in their medical history

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • Infection complications of mother / fetus
    • Time Frame: Up to 5 days from the birth
    • Clinical signs of infection are defined as follows: CRP levels > 8 mg/l Leukocyte count > 18 x 109/l Body temperature > 37.5°C

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medicem International CR s.r.o.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ondrej Simetka, AssProf,PhD, Principal Investigator, Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
    • Lukas Hruban, M.D., Principal Investigator, Clinic of gynecology and obstetrics, University hospital of Brno, Czech Republic
    • Igor Michalec, M.D., Principal Investigator, Clinic of gynecology and obstetrics, University hospital of Ostrava, Czech Republic
    • Radovan Vlk, M.D., Principal Investigator, Clinic of gynecology and obstetrics, University hospital of II. Medicine college of Charles University in Prague, Czech Republic

References

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

Citations Reporting on Results

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.

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