ABSTRAK Latar Belakang
Perdarahan pascasalin adalah penyebab 25% kematian ibu diseluruh dunia,
bahkan mencapai 60% pada beberapa negara. Sekitar 60-90% disebabkan oleh
atonia uteri. Berbagai alat ditemukan dan digunakan seperti tamponade balon
uterus, NASG (Nonpneumatic Anti Shock Garment), Bakri Balloon dan The
Glenveigh Medical Complete Tamponade System namun memiliki efektifitas
sekitar 65-87,5% dan potensi komplikasi. Oleh sebab itu diperkenalkanlah suatu
metode baru untuk mengontrol perdarahan pascasalin.
Metode
Tujuan dari penelitian ini adalah untuk melihat keamanan, kemudahan dan
efektifitas alat InPress mengatasi perdarahan pascasalin karena atonia uteri. Alat
InPress menggunakan mesin vakum bertekanan rendah untuk menurunkan
tekanan atmosfer dalam kavum uteri sehingga uterus menjadi kolaps dan
membuat tamponade sehingga perdarahan berhenti. Selain itu secara fisiologis,
dapat merangsang kontraksi uterus pascasalin yang normal dan retraksi uterus ke
bentuk dan ukuran semula.
Hasil
Dari sepuluh subyek penelitian menunjukkan bahwa mesin vakum dengan cepat
menciptakan tamponade yang efektif melalui balon pengunci yang berada di
ostium uteri eksterna. Jumlah perdarahan yang dievakuasi dari kavum uteri sekitar
100-250 cc, tertampung dalam kanister. Uterus kolaps dan terjadi tamponade
dalam waktu 1-2 menit sehingga perdarahan berhenti. Alat InPress dipasang
selama minimal 1 jam dan maksimal 6,5 jam. Repair luka robekan perineum dan
vagina dapat dilakukan dengan mudah saat alat InPress terpasang di dalam uterus.
Pada sepuluh subyek tidak ada tindakan lanjutan untuk mengatasi perdarahan
setelah alat InPress dipasang. Tidak ditemukan adanya kelainan pada uterus,
serviks dan vagina pada saat dan sesudah pemasangan alat InPress.
Kesimpulan
Tamponade uterus yang berasal dari tekanan negatif mesin vakum terbukti aman dan efektif untuk mengatasi perdarahan pascasalin karena atonia uteri.
ABSTRACT Background
the Treatment of Postpartum Hemorrhage Due To Uterine
Atonia
Postpartum Hemorrhage (PPH) is responsible for +/- 25% of maternal mortality
worldwide, reaching as high as 60% in some countries. Approximately 60-90%
caused by uterine atonia. Many devices were invented and applied such as uterine
balloon tamponade, NASG (Nonpneumatic Anti Shock Garment), Bakri Balloon
dan The Glenveigh Medical Complete Tamponade System but the effectiveness
only about 65-87,5% control hemorrhage and have potential complications.
Therefor a new method to control PPH has been introduced.
Method
The purpose of this study was to demonstrate patient safety, device efficiency, and
ease of use, as an overall Proof of Concept with a new device, the InPress Device,
for the treatment of primary postpartum hemorrhage (PPH) due to atony.
The InPress device uses gentle vacuum force to lower the atmospheric pressure
within the uterine cavity to collapse the uterus into and onto itself to stop
hemorrhage through tamponade. It also stimulates normal postpartum uterine
contractions, to effect hemostasis. In this hemostatic state the atonic uterus
recovers, physiologically, and retracts down to its? normal hemostatic postpartum
size.
Results
Results from our ten trial patients showed that: the vacuum created an immediate
effective tamponade confined to the uterus by our seal situated at the external
cervical ostium, 100-250 milliliters of residual blood were evacuated from the
uterine cavity into the vacuum canister. The uterus collapsed and regained tone
within 1-2 minutes, and hemorrhaging stopped, in all cases. The device stayed in
place while vaginal and perineal lacerations, which occurred during delivery, were
easily repaired. The device was left in for one-hour minimum up to 6,5 hours.
There were no further operative procedures required to stop hemorrhaging in any
of these cases. There was no abnormality of uterus, cervix and vagina while and
after InPress procedur performed.
Conclusion
Vacuum induced uterine tamponade using physiologic force, is a safe and
effective way to achieve rapid control of PPH due to atony.
;Background
the Treatment of Postpartum Hemorrhage Due To Uterine
Atonia
Postpartum Hemorrhage (PPH) is responsible for +/- 25% of maternal mortality
worldwide, reaching as high as 60% in some countries. Approximately 60-90%
caused by uterine atonia. Many devices were invented and applied such as uterine
balloon tamponade, NASG (Nonpneumatic Anti Shock Garment), Bakri Balloon
dan The Glenveigh Medical Complete Tamponade System but the effectiveness
only about 65-87,5% control hemorrhage and have potential complications.
Therefor a new method to control PPH has been introduced.
Method
The purpose of this study was to demonstrate patient safety, device efficiency, and
ease of use, as an overall Proof of Concept with a new device, the InPress Device,
for the treatment of primary postpartum hemorrhage (PPH) due to atony.
The InPress device uses gentle vacuum force to lower the atmospheric pressure
within the uterine cavity to collapse the uterus into and onto itself to stop
hemorrhage through tamponade. It also stimulates normal postpartum uterine
contractions, to effect hemostasis. In this hemostatic state the atonic uterus
recovers, physiologically, and retracts down to its? normal hemostatic postpartum
size.
Results
Results from our ten trial patients showed that: the vacuum created an immediate
effective tamponade confined to the uterus by our seal situated at the external
cervical ostium, 100-250 milliliters of residual blood were evacuated from the
uterine cavity into the vacuum canister. The uterus collapsed and regained tone
within 1-2 minutes, and hemorrhaging stopped, in all cases. The device stayed in
place while vaginal and perineal lacerations, which occurred during delivery, were
easily repaired. The device was left in for one-hour minimum up to 6,5 hours.
There were no further operative procedures required to stop hemorrhaging in any
of these cases. There was no abnormality of uterus, cervix and vagina while and
after InPress procedur performed.
Conclusion
Vacuum induced uterine tamponade using physiologic force, is a safe and
effective way to achieve rapid control of PPH due to atony.
;Background
the Treatment of Postpartum Hemorrhage Due To Uterine
Atonia
Postpartum Hemorrhage (PPH) is responsible for +/- 25% of maternal mortality
worldwide, reaching as high as 60% in some countries. Approximately 60-90%
caused by uterine atonia. Many devices were invented and applied such as uterine
balloon tamponade, NASG (Nonpneumatic Anti Shock Garment), Bakri Balloon
dan The Glenveigh Medical Complete Tamponade System but the effectiveness
only about 65-87,5% control hemorrhage and have potential complications.
Therefor a new method to control PPH has been introduced.
Method
The purpose of this study was to demonstrate patient safety, device efficiency, and
ease of use, as an overall Proof of Concept with a new device, the InPress Device,
for the treatment of primary postpartum hemorrhage (PPH) due to atony.
The InPress device uses gentle vacuum force to lower the atmospheric pressure
within the uterine cavity to collapse the uterus into and onto itself to stop
hemorrhage through tamponade. It also stimulates normal postpartum uterine
contractions, to effect hemostasis. In this hemostatic state the atonic uterus
recovers, physiologically, and retracts down to its? normal hemostatic postpartum
size.
Results
Results from our ten trial patients showed that: the vacuum created an immediate
effective tamponade confined to the uterus by our seal situated at the external
cervical ostium, 100-250 milliliters of residual blood were evacuated from the
uterine cavity into the vacuum canister. The uterus collapsed and regained tone
within 1-2 minutes, and hemorrhaging stopped, in all cases. The device stayed in
place while vaginal and perineal lacerations, which occurred during delivery, were
easily repaired. The device was left in for one-hour minimum up to 6,5 hours.
There were no further operative procedures required to stop hemorrhaging in any
of these cases. There was no abnormality of uterus, cervix and vagina while and
after InPress procedur performed.
Conclusion
Vacuum induced uterine tamponade using physiologic force, is a safe and
effective way to achieve rapid control of PPH due to atony.
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