Dilapan-S Osmotic Dilator in Pre-induction of Labor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Dilapan-S 125 Patients with / without caesarean section in their medical history |
Device: Dilapan-S
Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
Other Names:
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Outcome Measures
Primary Outcome Measures
- Cervix (Bishop) score [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 Outcome Measures
- Total duration of pre-induction [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 [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 [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) [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 [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 [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 [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
Other Outcome Measures
- 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]
The evaluation of the course of removal of Dilapan-S after termination of preinduction by physician as very easy, easy, standard, with some complications or very complicated.
- 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]
Subjective satisfaction Pain experienced during Dilapan-S insertion and pre-induction phase Quality of relax and sleep Frequency and intensity of uterine contractions during pre-induction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Single pregnancy
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Pregnancy more than 36 weeks
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Vertex presentation of the fetus
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Cervix Score less than 4 points
Exclusion Criteria:
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Contraindication to vaginal delivery
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Pathological fetal station
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States after uterine body surgery - except for Caesarean section
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Clinical signs of uterine, vaginal or vulvar infection
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Fetus hypoxia (KTG recording evaluated as pathological prior to pre-induction initiation)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinic of Gynecology&Obstetrics, University hospital in Brno and Masaryk University Medical School | Brno | Czech Republic | 625 00 |
Sponsors and Collaborators
- Medicem International CR s.r.o.
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
None provided.More Information
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. Epub 2007 Jul 10.
- 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, Lopatinsky I, Shaw FM. Overcoming unsatisfactory colposcopy. Use of osmotic dilators. J Reprod Med. 1997 May;42(5):271-5.
- 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.
- 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.
- 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. Epub 2007 Nov 5.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- DIS2013-002