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Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study

R. Chodankar, J. Gupta, D. Gdovinova, MJ. Bovo, J. Hanacek, N. Kan, J. Roizin, V. Tyutyunnik,

. 2018 ; 228 (-) : 249-254. [pub] 20180711

Language English Country Ireland

Document type Journal Article, Multicenter Study, Observational Study

Persistent link   https://www.medvik.cz/link/bmc19000534

OBJECTIVES: To evaluate the outcomes with the use of Dilapan-S for cervical preparation prior to medical or surgical abortion. STUDY DESIGN: International, multicentre, prospective observational study in women between 6 + 0-24 + 0 weeks' gestation. The study was conducted across 7 study sites in 4 countries, between 1/5/2015 to 31/12/2016. The primary outcomes studied were the number of dilators used and the duration required for cervical preparation prior to abortion. Secondary outcomes were complications of dilator use and infection. Participants were followed-up for 4 weeks post procedure to capture any delayed complications. RESULTS: A total of 483 women were enrolled with 439 women eligible for analysis. Medical abortion was performed in 38% (n = 165) women and surgical abortion in 62% (n = 274). For medical abortions and surgical abortions, an average of 3 osmotic dilators for time interval of 4-7 hours provided effective cervical preparation. Medical abortions were performed as day-case procedures (<12 h) in 81% of women. There was no difference in using either adjunctive misoprostol or Dilapan-S followed by misoprostol for cervical ripening effect to achieve complete medical abortion. Dilapan-S permitted surgical abortions to be performed as same-day procedures (<12 h), in 85% of women regardless of gestational age and without the need to use adjunctive or additional misoprostol. There were no serious adverse events reported with the use of Dilapan-S, including in women with a previous caesarean section. The overall infectious morbidity was 0.9% of cases with no causal relationship with the use of synthetic osmotic dilator use (for a length <24 h). In addition, Dilapan-S was reported as easy to insert and remove in over 90% of women. CONCLUSION: Dilapan-S is a safe and effective method for cervical preparation for medical and surgical abortions up to 24 weeks' gestation. It allows medical and surgical abortions to be performed as day case procedures and is associated with a low complication rate. Future research should aim at directly comparing Dilapan-S and preferred pharmacological agents in a randomised controlled trial.

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$a Chodankar, Rohan $u Royal Infirmary of Edinburgh, Scotland, United Kingdom. Electronic address: rohan.chodankar@nhs.net.
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$a OBJECTIVES: To evaluate the outcomes with the use of Dilapan-S for cervical preparation prior to medical or surgical abortion. STUDY DESIGN: International, multicentre, prospective observational study in women between 6 + 0-24 + 0 weeks' gestation. The study was conducted across 7 study sites in 4 countries, between 1/5/2015 to 31/12/2016. The primary outcomes studied were the number of dilators used and the duration required for cervical preparation prior to abortion. Secondary outcomes were complications of dilator use and infection. Participants were followed-up for 4 weeks post procedure to capture any delayed complications. RESULTS: A total of 483 women were enrolled with 439 women eligible for analysis. Medical abortion was performed in 38% (n = 165) women and surgical abortion in 62% (n = 274). For medical abortions and surgical abortions, an average of 3 osmotic dilators for time interval of 4-7 hours provided effective cervical preparation. Medical abortions were performed as day-case procedures (<12 h) in 81% of women. There was no difference in using either adjunctive misoprostol or Dilapan-S followed by misoprostol for cervical ripening effect to achieve complete medical abortion. Dilapan-S permitted surgical abortions to be performed as same-day procedures (<12 h), in 85% of women regardless of gestational age and without the need to use adjunctive or additional misoprostol. There were no serious adverse events reported with the use of Dilapan-S, including in women with a previous caesarean section. The overall infectious morbidity was 0.9% of cases with no causal relationship with the use of synthetic osmotic dilator use (for a length <24 h). In addition, Dilapan-S was reported as easy to insert and remove in over 90% of women. CONCLUSION: Dilapan-S is a safe and effective method for cervical preparation for medical and surgical abortions up to 24 weeks' gestation. It allows medical and surgical abortions to be performed as day case procedures and is associated with a low complication rate. Future research should aim at directly comparing Dilapan-S and preferred pharmacological agents in a randomised controlled trial.
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$a Gupta, Janesh $u Birmingham Women's and Children's Hospital, Birmingham, England, United Kingdom. Electronic address: J.K.GUPTA@bham.ac.uk.
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$a Gdovinova, Daniela $u Ex-Medicem International, Prague, Czech Republic. Electronic address: daniela.gdovinova@centrum.cz.
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$a Bovo, Mary Jane $u Choices Women´s Medical Center, New York, United States. Electronic address: gstatuto@choicesmedical.com.
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$a Hanacek, Jiri $u Institute of Care for Mother and Child of 3rd Medical College, Prague, Czech Republic. Electronic address: Jhanacek@seznam.cz.
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$a Kan, Natalia $u Federal State Budget Institution «National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov» of the Ministry of healthcare of Russian Federation, Moscow, Russian Federation. Electronic address: kan-med@mail.ru.
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$a Roizin, John $u Allentown Women´s Center, Bethlehem, Pennsylvania, United States. Electronic address: jonesob@verizon.net.
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$a Tyutyunnik, Victor $u Federal State Budget Institution «National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov» of the Ministry of healthcare of Russian Federation, Moscow, Russian Federation. Electronic address: tioutiounnik@mail.ru.
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