1. Intra-uterine tamponade for post- partum hemorrhage management A controlled randmised trial in Vietnam ? Ho Chi Minh Ville, April 2013 Working group: -Vietnam: Dr To Van Trung - France: Dr Alexandre Dumont

2. Background Maternal mortality – Global health problem OMD for 2015 (1990-2015) ↘ ¾ maternal mortality in the World

3. Post-partum hemorrhage First cause of maternal mortality Maternal mortality remain stable – In countries with high MM ratios – Despite the standardization of treatments « New technology »: intra-uterine tamponade – WHO 2009 – « Should intrauterine balloon or condom tamponade be offered in the treatment of PostPartum Haemorrhage? » – Review of observational studies – Success rate : 71% à 100%

4. Intra-uterine tamponade

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 » may have the same effectivness as « Bakri » and less expensive Observational studies show a high success rate, but: – low level 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 should be included? How should we include? Randomization Outcomes After inclusion ?

8. Objective Test the effectivness of the intra-uterine tamponade in term of reducing severe maternal morbidity 2 countries: Benin et Mali 3 hospitals by country

9. Methods Multicentric controlled randomized trial. Arm A :Misoprostol (5 tablets - 200 µg) sub- lingual or intra-rectal + « condom-catheter » intra-uterine tamponade. Arm B :Misoprostol (5 tablets - 200 µg) sub- lingual or intra-rectal.

10. Key data Study duration: 12 months Study attending for each patient : between 24 hours and 15 days. Number of patients needed : 55 patients in each arm

11. Who should we inlcude? Patients with uterine atony resistant to oxytocin Are not inlcuded: – Cesarean delivery – Contraindication or allergy to prostaglandins – Allergy to latex – Chorioamniotis – Uterine rupture – Placenta accreta

12. How should we include? The most difficult step +++++ Randomization in emergency situation Verbal consent (written consent after) Management of PPH simultaneously Need: – a third person (to assist the clinician) a coordinator to centralize the randomization

13. Outcomes Primary outcome Recourse to surgery intervention: uterine aretry ligation via laparotomy and/or hysterectomy. Secondary outcomes – Hemorrhage > 1000 mL. – Transfusion. – Referral to adult ICU. – Maternal death

14. What’s happen after inclusion? The same day: – The management of the PPH is the priority – Note each step of the management in the clinical record – Collect the data using the standardized the questionnaire

16. – During hospitalization – Then 15 days after hospital dischrage (phone call) – Collect information on PPH, treatment, adverse effects of the treatments, maternal and perinatal outcomes Patient monitoring

17. Declare severe adverse effects Severe adverse effects are : - life-threatening complications - Sustainable inacapacity -choc (allergy) - endometritis - new hospitalization - maternal death

18. Questions Do you use intra-uterine tamponade in Vietnam? « condom-catheter » is relevant in Vietnam? A controlled randomized trial is feasible?

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.Attach this the condom to the catheter using a thread 3.Connect the seringue to the catheter. 4.Test the seal. 5.Place the catheter in the intra-uterine position. 6.Begin filling manually the condom until bleeding stops. 7.Hold the catheter in place in the uterus using a vaginal pack.

24. Place the condom on the catheter

25. Attach the condom to the catheter 1234

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. Alternative method to fill the condom End of the Foley catheter Adapter to the solute pack End of the infusion tubing

29. Manual filling with the solute pack 1 minute OpenClosed

30. Practical aspects 1 person « aspectic » – Assmble the device – Place the catherter in the intra-uterin position – Keep the catheter in the good position during filling – Vaginal packing 1 person non « aseptic » – Filling manually the condom – Team coordination

31. Monitoring Success in 15 minutes Sucess criteria +++ – Good hemodynamic (Aterial pressure, heart rate) – Vaginal bleeding – DO NOT PRESS THE FUNDAL OF THE UTERUS

32. Stop the tamponade. When? Duration of the tamponade – Minimum 6 hours – Maximum 12 hours (to prevent the sepsis) – Stop the tamponade when the team is complete How should we stop the tamponade – Delete half of the volume – Wait 1 hour – Then delete the remaining solute and the balloon

33. Condom-catehter Let us go …