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A prospective randomized comparative study of Misoprostol and balloon tamponade using condom catheter to prevent postpartum hemorrhage at M. Y. H., Indore, India in vaginal delivered patients

Postpartum hemorrhage may occur in 1-5% of deliveries in developed countries and is still the most significant cause of maternal morbidity and mortality. The WHO estimates that PPH accounts for nearly 30% maternal deaths worldwide with an estimated 20 million cases annually. Classically, PPH has been defined as a blood loss greater than 500ml after a vaginal delivery and greater than 1000ml after a cesarean section. Underestimation of post-delivery blood loss is not uncommon, and is likely contributed to, at least in part, by the ability of healthy pregnant women to lose up one liter of blood acutely without a noticeable drop in hemoglobin or significant hemodynamic change.

delivery of the fetus), abnormal placentation (placenta previa, accreta or increta), oxytocin use, maternal obesity, and a distended uterus (from a large baby, multifetal gestation or excessive amniotic fluid). [6][7][8] In developed countries, the maternal mortality of such hemorrhage has been reported to be on the order of 0.1% of all deliveries. 8 The aim of this study is to prevent maternal death at a primary health care center. The objective is to study the outcome among the medical method i.e. misoprostol and interventional method i.e. CC CG Balloon for preventing postpartum hemorrhage; to study the association of highrisk factors and the postpartum hemorrhage; to study the association of parity status and postpartum hemorrhage and to study the efficiency and time responsiveness of the interventions used for prevention of postpartum hemorrhage.

METHODS
It was a randomized prospective study carried out from 1 st March 2016 to 31 st August 2017 (18 months). Number of cases were 200.

Inclusion criteria
• All the vaginal delivered patients with atonic PPH at MYH after active management of third stage of labour during the duration of study.

Exclusion criteria
• Rule out causes due to traumatic PPH.
• Arterial bleeding requiring exploration and ligation or angiofigureic embolization. • Cases indicating hysterectomy or when uterine rupture is suspected. • Non gynaecological causes like cervical cancer.
All the cases were divided into two groups: one receiving 800 microgram misoprostol per rectally/sublingually and other group receiving CC. In around 105 cases Misoprostol was used and in another 95 cases CC was used. Cases were allocated using randomization by alternately allocating the cases to Misoprostol and CC group. After AMTSL wherever Misoprostol was used, authors watched for 10 minutes for bleeding to stop but if it did not stop authors insert CC to prevent deterioration of the cases. Further, if CC fails after 30-40 minutes cases are shifted to operation theatre and planned for sequential devascularization. Further when either of the options failed i.e. even after failure of stepwise devascularisation, authors proceed for hysterectomy. Table 1 showing distribution of cases with booked cases 77% and unbooked cases 23%.   Table 3 showing distribution of cases depending upon parity status; most commonly affected were third gravida group contributing 35% cases followed by second gravida 24% cases and primi gravida and more than or equal to four gravida contributing 29.5% and 11.5 % cases, respectively. The parity status with most common being third gravida group with 34 cases managed using Misoprostol and 47 cases managed using CC and 2 cases However, 3 cases underwent hysterectomy among primigravida after failure of either method.   Some cases may belong to superimposed category. Table 4 showing distribution of cases depending upon the pregnancy outcome with most cases belonging to category of Term pregnancy (59%) followed by preterm pregnancy (20%), postnatal cases (11%) and post term pregnancy (10%). And modality of treatment used with 35% of the cases of term pregnancy managed using CC and around 26% of the cases managed using Misoprostol. However, with failure of either method Hysterectomy was done in 2% cases.   Table 6 showing distribution of cases depending on intervention used; The Pearson chi square test was applied to see the association between whether PPH was controlled and the procedure used to do so. The value of this test was 47.028 and p value for this was 0.00 which was found to be clinically significant as p value is less than 0.05. Misoprostol was used successfully in 36% cases and CC was used successfully in 56.5% but misoprostol failed in 13.5% cases and CC failed in 2.5% cases. Table 7 showing Fischer's exact test was applied to see the association between PPH controlled and the high-risk factor associated with it. The p value for Fischer's exact test was 0.000 and this is less than 0.05 hence found to be clinically significant. Thus, there is positive association between PPH controlled and the associated high-risk factor. Some cases may belong to superimposed category. Table 8 showing distribution of cases according to booking status and modality of treatment used. The Fischer's Exact test was applied to see the association between PPH controlled and the Booking status of the cases. The p value for the test was 0.047 and it is less than 0.05 which is found to be clinically significant.  Table 9 showing independent t tests were applied and it was observed that the PPH to CG balloon interval, CG balloon inflation to hemostasis interval and hemostasis interval was found to be significant with the p value of 0.000 (<0.05). Thus, whether PPH is controlled or not is affected by the hemostasis interval, PPH to CG balloon Insertion interval and CG balloon inflation to hemostasis interval.  Table 10 showing distribution of cases receiving blood transfusion; 53% cases received blood transfusion while 47% cases did not receive blood transfusion.  Transfused  106  53  Not transfused  94  47  Total  200  100   Table 11 showing quantification of amount of blood loss on whether PPH was controlled or not; The amount of blood loss affects whether PPH was controlled or not. Independent t test was applied, and its p value was 0.000 (<0.05) which is found to be significant. In present study the mean amount of blood loss is 663.80ml in the cases in which PPH was controlled i.e. in 86.5% cases and 1100.00ml in the cases in which PPH was not controlled i.e. 13.5% cases. The minimum amount of blood loss was 400ml and the maximum was 1500ml. In study by Sheikh L et al, the mean blood loss was 2431±1817ml (range:1500-9000ml while in study by Tort J et al, the mean amount of blood loss is 800ml and in the study conducted by Martin et al, the mean blood loss before putting CC was 1343±223ml while mean blood loss after condom balloon insertion was 308±83.42ml. 9,13,14 Mean comparison of blood loss before and after condom balloon insertion was done and found to be statistically significant (p<0.001). The same result was found in my study that the PPH to CG balloon interval, CG Balloon inflation to hemostasis interval and Hemostasis interval was found to be significant with the p value of 0.00 which is less than 0.05 and was found to be significant. In study by Thapa K et al, CC was applied to fourteen cases with varying degrees of PPH, not controlled with pharmacologic measures. 15 Average amount of blood loss was 1221ml and it was 1480ml in study conducted by Ahmad SN et al. 16 In a study of case series by Mishra N et al, the mean blood loss was 1611ml. 12 In the study by Ahmad SN et al, the mean time taken to arrest bleeding after the application of the CC was 6.66 minutes. 16

CONCLUSION
Outcome is affected by the booking status of cases. Age has no significant association with whether PPH is controlled or not. Parity status does not affect whether PPH is controlled or not. Outcome is significantly affected by the hemostasis interval, PPH to CG balloon insertion interval and CG balloon inflation to hemostasis interval. CC was found to be more cost effective, being cheaper and easily available at primary health care centre. Misoprostol can be misused for MTP and unwanted pregnancies, so we can aptly use CC for saving life.