Ho Chi Minh Ville, April 2013 Working group : Vietnam: Dr To Van Trung

1. Intra-uterinetamponade for post-partum hemorrhage managementA controlledrandmised trial in Vietnam ? Ho Chi Minh Ville, April 2013 Working group: Vietnam: Dr To Van Trung - France: Dr Alexandre Dumont

2. Background • Maternalmortality • Global healthproblem • OMD for 2015 (1990-2015) ↘ ¾ maternalmortality in the World

3. Post-partum hemorrhage • First cause of maternalmortality • Maternalmortalityremain stable • In countries withhigh MM ratios • Despite the standardization of treatments • « New technology»: intra-uterinetamponade • WHO2009 • « Shouldintrauterineballoon or condom tamponade beoffered in the treatment of PostPartumHaemorrhage? » • Review of observationalstudies • Success rate : 71% à 100%

4. Intra-uterinetamponade

5. GEORGIOU C. Intraluminal pressure readings during the establishment of a positive 'tamponade test' in the management of postpartum haemorrhage. BJOG 2010;117:295-303.

6. Problem • The device «condom-catheter »mayhave the sameeffectivness as « Bakri » and lessexpensive • Observationalstudies show a highsuccess rate, but: • lowlevel of evidence • Publication biais • Need to compare with a standard of care (control)

7. Trial in Benin and Mali (Africa) • Objective • Méthodology • Key data • How shouldbeincluded? • How shouldweinclude? Randomization • Outcomes • After inclusion ?

8. Objective • Test the effectivness of the intra-uterinetamponade in term of reducingseverematernalmorbidity • 2 countries: Benin et Mali • 3hospitals by country

9. Methods • Multicentriccontrolledrandomized trial. • ArmA :Misoprostol (5 tablets - 200 µg) sub-lingualor intra-rectal + « condom-catheter » intra-uterinetamponade. • ArmB :Misoprostol (5 tablets - 200 µg) sub-lingual or intra-rectal.

10. Key data • Studyduration: 12 months • Studyattending for each patient : between24 hoursand15days. • Number of patients needed: 55 patients in each arm

11. Whoshouldweinlcude? • Patients withuterineatonyresistant to oxytocin • Are not inlcuded: • Cesareandelivery • Contraindication or allergy to prostaglandins • Allergy to latex • Chorioamniotis • Uterine rupture • Placenta accreta

12. How shouldweinclude? • The mostdifficultstep +++++ • Randomization in emergency situation • Verbal consent (written consent after) • Management of PPH simultaneously • Need: • a thirdperson (to assist the clinician) a coordinator to centralize the randomization

13. Outcomes • Primaryoutcome Recourse to surgery intervention: uterinearetryligation via laparotomy and/or hysterectomy. • Secondaryoutcomes • Hemorrhage > 1000 mL. • Transfusion. • Referral to adult ICU. • Maternaldeath

14. What’shappenafter inclusion? • The sameday: • The management of the PPH is the priority • Note eachstep of the management in the clinical record • Collect the data using the standardized the questionnaire

16. Patient monitoring • Duringhospitalization • Then 15 daysafterhospitaldischrage (phone call) • Collect information on PPH, treatment, adverse effects of the treatments, maternal and perinataloutcomes

17. Declaresevere adverse effects Severe adverse effects are : - life-threatening complications - Sustainableinacapacity -choc (allergy) - endometritis - new hospitalization -maternaldeath

18. Questions • Do you use intra-uterinetamponade inVietnam? • « condom-catheter » is relevant in Vietnam? • A controlledrandomized trial isfeasible?

19. Training group

20. material • Foley catheter • Condom • One-liter bag of solute • Needleless suture • 50-mL syringe • Obturator

22. Assembly of the condom-catheter

23. Steps to assemble 1. Place the condom on the catheter. 2. Attachthis the condom to the catheterusing a thread 3. Connectthe seringue to the catheter. 4. Test the seal. 5. Place the catheter in the intra-uterine position. 6. Begin fillingmanually the condom untilbleeding stops. 7. Hold the catheter in place in the uterususing a vaginal pack.

24. Place the condom on the catheter

25. Attachthe condom to the catheter 1 2 3 4

26. Place the catheter in the intra-uterine position

27. Fill the condom:The condom is inflated in increments of 250 mL of solute using a 50 mL syringe without exceeding 1000 mL.After each increment was added, if bleeding continued after five minutes, the clinician continued filling the condom until the maximum level was reached.If successful, vaginal packing to prevent accidental removal of the condom catheter, and the Foley catheter is clamped.

28. Practical aspects • 1 person « aspectic » • Assmble the device • Place the catherter in the intra-uterin position • Keep the catheter in the good position duringfilling • Vaginal packing • 1 person non « aseptic » • Fillingmanually the condom • Team coordination

29. Monitoring • Success in 15 minutes • Sucesscriteria+++ • Good hemodynamic (Aterial pressure, heart rate) • Vaginal bleeding • DO NOT PRESS THE FUNDAL OF THE UTERUS

30. Stop the tamponade. When? • Duration of the tamponade • Minimum 6 hours • Maximum 12 hours (to prevent the sepsis) • Stop the tamponadewhen the team iscomplete • How shouldwe stop the tamponade • Deletehalf of the volume • Wait1 hour • Thendelete the remainingsolute and the balloon

31. Condom-catehter Let us go …