EVERY SECOND MATTERS FOR MOTHERS AND BABIES UTERINE

EVERY SECOND MATTERS FOR MOTHERS AND BABIES UTERINE BALLOON TAMPONADE (ESM-UBT) IN WOMEN WITH PPH FROM ATONIC UTERUS A MULTICENTRIC STUDY MAHATMA GANDHI INSTITUTE OF MEDICAL SCIENCES, SEVAGRAM

GREETINGS FROM MGIMS AND HARVARD UNIVERSITY

THE BRAIN BEHIND………. . DR THOMES BURKE ALONG WITH HIM, DR MOYATREE AND TEAM

Introduction • PPH is the world’s greatest cause of maternal death • Atonic uterus is the most common cause of PPH • Medical methods are first choice, however, worldwide between 1. 5% to 4. 5% of the time uterotonics fail • Surgical approaches to atonic PPH are the last option but may include various brace sutures to stepwise ligation to finally hysterectomy. • Additional advanced procedures such as uterine artery embolization are not available at most facilities and do indeed require considerable expertise Several mechanical methods may be tried to reduce the bleeding such as bimanual compression and aortic compression however, UBT is more effective Potential Solution UTERINE BALLOON TEMPONADE As easy to use, no expertise required, non doctors can also use it. Evidence based research has proved its efficacy in several countries

Preliminary work done Dr Thomas Burke, Harvard University has performed several studies and published papers on the utility of UBT in PPH to save every woman, the studies have been conducted in developing countries where PPH is a killer Additional evidence from urban populations in India (high risk) and other developing countries where UBT has been implemented, show very promising results RECOMMENDED BY FOGSI AND GOVT OF INDIA Before promoting the ESM – UBT A multicentric study was needed to be conducted in urban as well as rural areas

Why did we take up this project? -PPH STILL A MAJOR KILLER IN RURAL AREAS -THE UBT IS A RECOMMENDED METHOD -THE COST WAS SO AFFORDABLE AS COMPARED TO EXISTING UBTS - 150 evidence – 200 Rs AS COMPARED TO 7000 Rs Additional from urban populations in India (high risk) and other developing countries where UBT has been -Dr Thomas implemented, Burke, Global Health show very Chiefpromising of Emergency results Division, Harvard RECOMMENDED University was ready to give his. GOVT patent. OFand wanted BY FOGSI AND INDIA Indian Government to scale up in India -His studies have shown benefits of UBT in lower settings and during transits -

Goals and Objectives Goal To assess the utility , acceptance, efficacy and compliance of ESM - UBT balloon for managing Atonic PPH and evaluate for reduction of maternal mortality Objectives To assess the efficacy of a simple, cost effective management of PPH To demonstrate the feasibility and acceptability of using this EBM - UBT in a lowresource rural setting

Methodology • Study Design : Prospective study of delivered women with ATONIC PPH and follow them up in postpartum period for final outcome • Study Period: 6 months initially and then for 2 years • Study Area: 10 medical colleges – MGIMS SEVAGRAM, JNMC SAWANGI, IGMC NAGPUR, NPK SALVE MEDICAL INSTITUTE NAGPUR, GMC AURANGABAD, GMC BHOPAL, PRAVARA INSTITUTE OF MEDICAL SCIENCES LONI, GMC CHANDRAPUR AND PDMC AMRAVATI • Study key – ESM - UBT • Data Analysis: SPSS version 22. 0 or as per need

Parts of ESM-UBT • A wide bore catheter with single channel valves • Two high quality condoms • Two threads • 60 cc syringe • Catheter holder • Data and procedure demonstration cards Tracking tool is DATA MONITORING CARD

Methodology • All the women who had ATONIC PPH who did not respond to the medical management were the subjects • All the women who gave their consent were included in the study, where the women were incapable to give consent relative gave the consent • ESM – UBT balloon was used • UBT was done as described in the training in which the kit was opened , condom was placed on the foley’s catheter and tied with the provided thread and this prepared uterine balloon was inserted in the uterus

Methodology • First foley’s catheter bulb was inflated to place it in the uterus, the port was identified with red mark and then the fluid in the form of N/S or R/L or Water can be instilled in the second port to inflate condom, the amount of fluid instilled will be varying patient to patient and was filled until bleeding reduces or stops. Upper limit - 1000 cc and lower limit - 300 cc • As bleeding stops, the woman was shifted to ICU and monitored and after 12 to 24 hours the balloon was slowly decompressed. Gradual removal of fluid ranging from 50 cc to 100 ml was done. UBT can be kept till 24 hrs and antibiotics cover was the decision of the obstetrician

Inclusion and Exclusion Criteria Inclusion Criteria: § Women who give the consent , if in case the women are not in the state of giving consent then consent of relatives have to be taken § Women who have atonic PPH where uterotonics have been given and she is not responding Exclusion criteria • Traumatic PPH • Cases where surgery is mandatory as retained placental tissues, invasive moles, morbid adhesions of placenta etc • Consent not given

Ethical Considerations ØInformed consent ØData Management and confidentiality Ø Risk and protection ØCompensation

Workshops at all 10 centres

Advantages of ESM- UBT • Technique of insertion is simple, even a nurse and midwives can insert • Worked very well , saves women’s life and surgery avoided • Needs head low position while inflating balloon, watch for fundal height and it fits nicely • Controls uterine bleeding immediately/ with in 15 mins • User friendly • Effective tool for management of all variety of PPH • Very useful in Atonic PPH with c- section • Success is because of catheter holder device placed on medial aspect of thigh • It falls back and probably makes uterus retroverted and kinks uterine artery

Results Ø 70 successful UBT, saved many lives ØAmount of fluid requires on an average 550 cc ØMaximum amount of fluid required 900 cc and minimum required 350 cc ØInsertion to cessation of bleeding interval – Average of all the cases in all the centres came – 37 mins ØMaximum time UBT placed in the uterus was 32 hours and minimum was 6 hrs when bleeding ceased

Results ØEXPULSION OF BALLOON OCCURED IN 6 CASES BUT NONE OF THEM BLED AFTER THAT ØSlow deflation was done in all the cases ØTotal deflation time was 5 hrs in UBT with maximum fluid instilled and 2 hrs with minimum fluid ØReinsertion was needed only in 2 cases as balloon came out

Results Ø 64 were put by doctors and 6 by nurses Ø No one had any problem in insertion Ø All were of opinion that CATHETER HOLDER IS A DEVICE WHICH HELPS A LOT IN RETAINING THE BALLOON IN THE UTERUS Ø 2 Maternal mortality in GMC Aurangabad, first one was Jaundice with bilirubin 18 mg% and other wwas in irreversible shock with no pulse and BP, both cases were referred cases with more than 10 hrs delayed in reaching the medical college Ø In 3 cases till now UBT was placed but bleeding was so much and maternal deterioration was there so they were taken for postpartum hysterectomy Ø I Case had ARF ---- Dialysis ------ 29 days creatinine was back to 1. 2 mg%

SR. NO NAME OF CENTRES NO. OF CASES INDICATIONS OF ESM –UBT USE ESM- UBT DETAILS OF ALL CENTERS AT PPH TR PM PA POST PP SEC PPH EVAC RPR MATERNAL OUTCOME PPH 1 MGIMS SEVAGRAM 11 7 2 - 1 - - 1 ALL SURVIVED 2 PRAVARA INSTITUTE OF MEDICAL SCIENCES 09 8 - - - 1 - - ALL SURVIVED 3 GMC CHANDRAPUR 05 5 - - - ALL SURVIVED 4 GMC NAGPUR 04 3 - - 1 - - ALL SURVIVED 5 IGGMC NAGPUR 07 7 - - - ALL SURVIVED 6 JNMC SAWANGI 08 7 1 - - - ALL SURVIVED 7 LMHRC NAGPUR 05 4 - -1 - - 1 - ALL SURVIVED 8 PDM MEDICAL COLLAGE AMRAVATI 04 3 - - - 1 - ALL SURVIVED 9 GMC BHOPAL 05 5 - - - ALL SURVIVED- 10 GMC AURANGABAD 12 12 - - - TWO DIED

JAN 2016 TO JUNE 2016 JULY 2016 TO DECEMBER 2016 JAN 2017 TO JUNE 2017 Total Number Of Deliveries 2, 344 2, 292 2, 4 55 Number Of Cases Of PPH 24 26 18 PPH Cases With Surgical Intervention Done 2 3 0 PPH Cases In Which UBT Used 0 0 11 Number Of Deaths Due To PPH 2 2 0

Future of ESM - UBT – Definite change in unnecessary surgical interventions and their risks – UBT can be used in lower settings due to its simple technique of insertion – Can be used in transit instead of packing which is very deceptive and not a recommended technique – Needs to be manufactured in India – Government needs to adopt it as a National policy – It will reduce MM AND CFR

Thank you !