THE USE OF NEW INSERTER (R_INSERTER) FOR DELIVERING CuT-380A IUD DURING POSTPARTUM PERIOD PHASE II CLINICAL TRIAL

Siswosudarmo, Risanto; Kurniawan, Kadek Agus; Suwartono, Herdhana; Alkaff, T. R.; Anggraeni, Maria

doi:10.22146/jkr.5750

Cited by 2 publications

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“…The same for the expulsion rate, the present study was 4.3%, much lower than our previous study which was 9.9% until three months follow up and then increased to 10.6% at six months. 11 Other study reported that PID rate was 1.6 per 1000 women per year 8 , while expulsion rate was 4%. 12,13 A multicenter study using CuT 380A IUD inserted by forceps ring during postpartum period reported expulsion rate 13.8%, 16.6% and20.5% each for the fi rst, third and sixth months follow up, respectively.…”

Section: Discussionmentioning

confidence: 97%

“…It was higher compared with expulsion rate reported during interval insertion, but it was not different compared with another study of postpartum IUD insertion. 11 The primary objective of the present study was to compare the safety of CuT 380A IUD inserted by R-inserter and ring forceps during postpartum period, or during the fi rst two hours after delivery of placenta. The secondary objective was to fi nd out the effectiveness (pregnancy rate), and its continuation of use.…”

Section: Abstrakmentioning

confidence: 99%

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CuT 380A IUD Inserted by R-Inserter and Ring Forceps during Postpartum Period A Randomized Clinical Trial, Twelve Months Follow Up

Siswosudarmo¹,

Nugroho

Kurniawan

et al. 2020

Indones J Obstet Gynecol

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Abstract Objective: To compare the safety and effectiveness of CuT 380A IUD use inserted by R-inserter compared with those inserted by ring forceps during the postpartum period.Methods: The study was conducted in three puskesmas (community health centre) as affiliated of Sardjito Hospital. Subjects meeting the inclusion and exclusion criteria were recruited to get a 10% proportion expulsion rate difference, type one error 0.05 and type two error 0.20. Insertion using R-inserter was treated while using ring forceps belonged to the control groups. Follow up was carried out one week after the insertion, one month and then monthly for 12months. Rate of the following events i.e.infection, expulsion, pain, bleeding, removal and continuation of use were primary outcomes of interest.Results: A total of 208 eligible subjects were recruited, consisting of 104 subjects using R-inserter and 104 subjects using ring forceps. Cumulative event rates during 12 months follow up were 1%, 4.3%, 3.4%, 10.1% and 4.8% each for infection, expulsion, bleeding, pain, and removal respectively. There was no difference in the rate of infection between the two groups, i.e. 1,0% for each group. There was one pregnancy over 208 subjects giving the overall failure rate of 0.5%. The overall results showed that there were no differences among those events rates (pain, bleeding, removal and continuation) between R-inserter and ring forceps groups. Continuations rate were 93.7%, 93.2%, 90.8%, and 90.8% each for three, six, nine and 12 months follow up respectively.Conclusions: There were no differences in terms of event rates between the use of CuT 380A IUD inserted by R-inserter and ring forceps.Keywords: continuation rate, expulsion, infection, postpartum IUD, R-inserter AbstrakTujuan: Membandingkan keamanan dan keefektifan pemakaian IUD CuT 380A pascasalin yang dipasang dengan R-inserter vs klem cincin.Metode: Penelitian dilakukan di 3 puskesmas di provinsi DIY. Pasien yang memenuhi kriteria kelayakan dimasukkan dalam penelitian ini untuk memenuhi beda proporsi ekspulsi 10%, kesalahan tipe satu 0,05 dan kesalahan tipe dua 0,20. Kelompok uji adalah mereka yang dipasang IUD dengan R-inserter dan kelompok control adalah mereka yang dipasang dengan klem cincin.Follow up dikerjakan setelah satu minggu, satu bulan dan setiap bulan sampai 12 bulan. Infeksi, ekspulsi, nyeri, perdarahan, pelepasan dan kelangsungan pemakaian adalah hasil utama yang diteliti.Hasil: Sebanyak 208 subyek penelitian memenuhi kriteria kelayakan, terdiri atas 104 subyek dipasang dengan R-inserter dan 104 subyek dengan klem cincin. Kejadian kumulatif pada seluruh kasus selama 12 bulan follow up adalah 1%, 4,3%,3,4%, 10,1%, 4,8% masing-masing untuk infeksi, ekspulsi, perdarahan, nyeri, dan pelepasan. Angka infeksi masing-masing sebesar 1% pada kedua kelompok. Terdapat satu kehamilan (0,5%) dari seluruh kasus. Angka kejadian yang lain (nyeri, perdarahan, pelepasan dan kelangsungan pemakaian) tidak menunjukkan perbedaan yang bermakna. Angka kelangsungan pemakaian kumulatif adalah 93,7%, 93,2% 90,8%, dan 90,8% masing-masing pada follow up tiga, enam, Sembilan dan 12 bulan pascapasang.Kesimpulan: Tidak ada perbedaan dalam hal kejadian efek samping antara pemakaian IUD CuT 380A yang dipasang pada masa pascasalin denganR-inserter dan klem cincin.Kata kunci: Angka kelangsungan, ekspulsi, infeksi, IUD pascasalin, pelepasan, R-inserter.

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Section: Discussionmentioning

confidence: 97%

Section: Abstrakmentioning

confidence: 99%

CuT 380A IUD Inserted by R-Inserter and Ring Forceps during Postpartum Period A Randomized Clinical Trial, Twelve Months Follow Up

Siswosudarmo¹,

Nugroho

Kurniawan

et al. 2020

Indones J Obstet Gynecol

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“…Pada penelitian tersebut penggunaan IUD pascasalin dinyatakan aman, dengan angka infeksi sebesar 1%, keluhan perdarahan 10.1%, dan angka diskontinyu sebanyak 4.8%. 7,8 Konseling IUD pascasalin idealnya dilakukan saat periode asuhan antenatal (AAN). Bila konseling saat AAN tidak kerjakan, maka konseling dapat dilakukan pada: 1) saat memasukkan pasien ke rawat inap 2) saat fase fase laten, 3) saat hari pertama pascasalin, 4) sebelum operasi sesar yang terjadwal.…”

Section: Pendahuluanunclassified

Pengaruh Konseling Antenatal terhadap Tingkat Penerimaan IUD Pasca Salin:Non RCT

Kurniawan¹,

Siswosudarmo²

2019

Jurnal Kespro

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Background: Postpartum period is a period where a woman has a great motivation to use a contraceptive. The present data showed that the use of IUD was only about 7,75% of all mixed contraceptive use. Counseling carried out during the antenatal care period continued during early labor is believed be able to increase its acceptance. Objective: To compare the effect of antenatal counseling continued during the early labor versus counseling in the early labor only on the acceptance of postpartum IUD use.Method: The study was carried out in Sardjito Hospital and several Puskesmas in the province of Yogyakarta during six months period from January to June 2015. A non-randomized controlled trial (quasi experimental design) was used. Pregnant women meeting the inclusion and exclusion criteria that are counseled during their antenatal visit continued during their early labor were assigned as the exposed group. Those who are counseled during the early labor only were assigned to the control group. Counseling was done using a specific designed card introduced by BKKBN. The main outcome of interest is the real insertion of postpartum IUD. Chi square test, relative risk and logistic regression were used for statistical analysis.Result and Discussion: A total of 144 subjects were recruited consisting of 72 subjects as the exposed group and 72 as the control. Both groups were comparable in terms of age, parity, education, mode of delivery, and history of previous IUD use. The rate of IUD insertion on the exposed group was 52.8% compared to 26.4% in the control (RR 2.00; 95% CI 1.28-3.12). Other factors contributing to the acceptance of postpartum IUD were mode of delivery and previous IUD use. Logistic regression showed that the most dominant factor contributing to the acceptance of postpartum IUD was history of previous IUD use, (OR 8,42; 95% CI 1,68–42,27) followed by mode of delivery (OR 4.96; 95% CI 1.86–13.26), while timing of counseling was the third (RR 2.93; 95% CI 1.36–6.32).Conclusion: Counseling carried out during ANC continued in the period of early labor increased significantly the acceptance of postpartum IUD. Other factors contributing to the acceptance of IUD use were history of previous IUD use and mode of delivery.Key words: Postpartum IUD; Time of Counseling; Antenatal Care; Rate of Acceptance; IUD pasca salin; waktu konseling

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THE USE OF NEW INSERTER (R_INSERTER) FOR DELIVERING CuT-380A IUD DURING POSTPARTUM PERIOD PHASE II CLINICAL TRIAL

Cited by 2 publications

References 4 publications

CuT 380A IUD Inserted by R-Inserter and Ring Forceps during Postpartum Period A Randomized Clinical Trial, Twelve Months Follow Up

CuT 380A IUD Inserted by R-Inserter and Ring Forceps during Postpartum Period A Randomized Clinical Trial, Twelve Months Follow Up

Pengaruh Konseling Antenatal terhadap Tingkat Penerimaan IUD Pasca Salin:Non RCT

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