INTRA UTERINE CONDOM BALLOON TAMPONADE-A LIFE SAVING MEASURE IN ATONIC PPH

Objective-To assess the effectiveness of intrauterine condom balloon tamponade in achieving haemostasis, in cases of atonic post partum haemorrhage. Design-Prospective observational study Setting-Emergency labour room of Obstetrics and Gynaecology Department of a tertiary care hospital & teaching institution Study periodJanuary 2013-December 2015 Material & methods-Thirty women having atonic PPH in whom active management of third stage of labour and uterotonics were not effective, were selected for this study. With full aseptic and antiseptic precautions a condom was tied on a nasogastric tube and was inserted into the uterine cavity, the distal end of the tube was connected to an IV set through which 250-500cc normal saline was instilled to inflate the condom so as to achieve haemostasis. Observation-46.6% women were between 25-30 yrs of age, 53.3% were multigravida. The gestational age was between 37-40 weeks in 80% cases. In 53.3% cases, there was some associated risk factor for PPH. In 72.72% cases placenta took alonger time to separate. In 66.6% women 250-500ml saline was instilled to inflate the condom balloon. It took 10-15 minutes time from insertion of the condom balloon catheter to achieve haemostsis in 73.3% women. The condom balloon catheter was kept in situ for 12-24 hrs in 73% women. Success rate of balloon tamponade was 90%. There was no infection in any case. Conclusion-Intrauterine condom balloon tamponade is effective, cheap and requires little skill. It can be used as a second line intervention in the management of atonic PPH. Skilled birth attendants in remote areas can use this technique and then transfer the woman to tertiary care unit. This will help in saving many maternal lives.


INTRODUCTION
Post partum haemorrhage accounts for a quarter of maternal deaths 1 . Death from PPH can largely be avoided through proper prevention, diagnosis and management 2,3 . 80% of maternal deaths can be prevented through actions that are effective and affordable in developing country settings [WHO, UNICEF & UNFPA -2001]. Active management of third stage of labour can prevent up to 60% cases of PPH 4 . But it still accounts for 31% of maternal deaths in Asia 5 .
Uterine atony is the commonest cause of PPH accounting for 70-80% of cases 6,7 . If bleeding is controlled immediately severe PPH can be prevented and we can save the patient from severe morbidity and mortality. Unfortunately many women in resource scarce settings do not have access to good quality care for the delivery. They are therefore at high risk of morbidity or death consequent to PPH 8,9 . Uterotonic agents are the first line of management. If they fail, intrauterine balloon tamponade has been used as a second line procedure in women with PPH 10 .
WHO has recommended the use of balloon tamponade for the treatment of PPH due to uterine atony in its updated guidelines [2012]. FIGO included uterine balloon tamponade as a recommended second line intervention for the treatment of PPH in their updated guidelines 2012 11 . In 1983 Goldrath published evidence that inserting foley's catheter in uterine cavity and inflating it with water could achieve tamponade 12 . Among the type of balloons used to produce tamponade are Sengstaken-Blackmore tube 13,14 -the Rush catheter 15 , the Bakri tamponade balloon catheter 16,17 and the male condom balloon catheter 18,19,20 .
Dr. Sayeba Akhtar introduced a novel device the male condom tied to the rubber catheter and used it forintrauterine balloon tamponade in 2001. This is very cost effective and easy to use method which requires minimum skill.
This study was carried out to find out the efficacy of intrauterine condom balloon tamponade in controlling atonic PPH.

METHODS
Male latex condom which is available in hospital was used in the study.
The patient was put in lithotomy position and with full aseptic and antiseptic precautions this procedure was done. Indwelling catheterization was done. Condom was tied on the nasogastric tube with a thread 4-5cm from the tip. With the help of two Sims speculum the cervix was visualized. Anterior lip of the cervix was held by the sponge holder. The condom which was tied on the nasogastric tube was inserted inside the uterine cavity with the help of sponge holder or digitally for up to 14-15cm. IV transfusion set was attached to the distal end of the tube and the condom was slowly filled with normal saline. After filling the condom with 250ml of fluid we watched for the bleeding [tamponade test]. If there was no bleeding or the bleeding reduced we waited and observed. If the bleeding continued the condom was inflated with more fluid. The minimum amount of fluid which we used for this study was 250ml and maximum 500ml. We waited for 5-15 minutes to see the response, if the bleeding was controlled we clipped the nasogastric tube at 6-7cm from the cervix and cut the remaining portion of the distal end. Stopper was applied on the distal end of the vaginal portion.
A tight vaginal pack was done to keep the condom catheter in position. Oxytocin drip was given for 6 hours and prophylactic antibiotics were given. When the woman became stable and vital parameters improved we kept this condom balloon in situ for a minimum of 12-24 hrs. Then we slowly deflated the condom over 10-15 minutes and if there was no bleeding we removed it from the uterus and vagina. Close monitoring of the woman's vital was done for 24 hrs. In three patients, in which bleeding was not controlled by this method, surgical intervention had to be done.  The duration of time in achieving hemostasis was from 5 to 8 minutes in 60% cases & 9 to 15 minutes in 40%

DISCUSSION
Thirty cases of atonic PPH were selected for this study to know the effect of intrauterine condom balloon tamponade in controlling atonic PPH in which the 1 st line management of utertonic drugs had failed. The presumed mechanism of action of the tamponade in stopping the bleeding is by creating an intrauterine pressure which exerts hydrostatic pressure on the capillaries and veins in the uterus. The pressure does not necessarily have to be higher than the systemic arterial pressure.
In addition, hydrostatic pressure effect of the balloon on the uterine arteries has been proposed and stimulation of uterine contractions by balloon in the cervix has also been demonstrated.
Majority of our patient 46.6% were in the age group of 25-30 years and 53.3% cases were multipara. In Tindell review 21 women who underwent UBT for PPH ranged in parity from 1 to 10 and were aged 18-40 years.
The gestational age was 37 to 40 weeks in our series. Active management of labour was done in 73.3% of our cases. In Tindells review 21  The estimated blood loss in our study was from 500-1000 ml. The highest reported estimated blood loss successfully managed by UBT was 5000 ml in Thapas study reviewed by Tindell. In our series we had selected all cases of atonic PPH where as in the review by Tindell 21 additional causes of PPH included coagulopathy, placenta accreta and placenta previa. The third stage of labour was prolonged >15-20% in 12 cases (72.72%). In those cases in which the third stage of labour was prolonged there was atonic PPH.
We inserted the condom catheter in the uterine cavity manually and in some cases by sponge holding forceps. We used gravity inflation and an intravenous infusion set to inflate the condom.
Once inside the uterus we used 250-500 ml of saline to inflate the condom and inflation was stopped when bleeding ceased or there was resistance to saline.
The time required for PPH to be controlled after placement of condom catheter ranged from 5-15 minutes in our study. This had similarity with other studies reviewed by Tindell 21 . We packed the vagina with gauze dressings to prevent catheter from falling out of the uterus once bleeding had ceased. Seven of the eight studies (n=191) reviewed by Tindell 21 used a vaginal pack to prevent condom catheter from falling out of the uterus.
We had given oxytocin drip for six hours from the time of insertion of the condom catheter. Tindell 21 in his review has observed that in six studies (n=118 women) an oxytocin drip was given upto 6 hours from the time of insertion of catheter. Shivkar et al 26 did not report the use of any uterotonics concurrent with condom catheter (n=73). In one successful case reported by Rathore, Manaktala et al 27 oxytocin was administered only during the removal of condom catheter.
The catheter was kept in situ for 12-24 hours in our study. In Tindell review 21 the length of time reported between insertion of condom catheter and removal ranged from 6 hours to 72 hours. We deflated the catheter slowly from 10-30 minutes.
The time taken to deflate the UBT varied from 10 minutes to 6 hours in Tindells review 21 .
We did not have infection in any case. In eight studies reviewed by Tindell 21 (n=193) in women using the condom catheter there were no reports of increased infection rate. Seven of the studies (n=120) reported prophylactic use of broad spectrum antibiotics. Shivkar et al 26 did not report using any antibiotic and reported no case of infection or fever in their series (n=73). We used prophylactic antibiotic Ceftriaxone 1 gm IV twice, Amikacin 500mg IM twice daily and Metronidazole I.V infusion.
We had three failures for which surgical intervention was done. Rathore et al 27 reported success in 25 of 26 women with one failure for which emergency hysterectomy was done. Shivkar et al reported 5 failures in their study for which surgical intervention was done.
In our study UBT was successful in 90% of cases in the review by Tindell 21 the success rate of UBT varied from 93% to 100% in various studies.

CONCLUSION
Intrauterine condom balloon tamponade has been found to be effective in managing atonic post partum haemorrhage. It is easy, safe and effective and preserves fertility. It should be an integral part of labour ward protocols for management of post partum hemorrhage. It can be used by the skilled birth attendants for transferring the patient from remote periphery to tertiary care centres.
Hence, we conclude that intrauterine condom balloon tamponade is an effective method in saving maternal lives from PPH.