Prevention Of Primary Postpartum Haemorrhage Research Articles

Intrauterine Misoprostol plus Oxytocin versus Oxytocin only in Prevention of Primary Postpartum Hemorrhage: Randomized Controlled Trial

Intrauterine Misoprostol plus Oxytocin versus Oxytocin only in Prevention of Primary Postpartum Hemorrhage: Randomized Controlled Trial

Effect of Intravenous Tranxenamic Acid On Incidence of Postpartum Haemorrhage Among Parturients in Ekiti State

Post-partum haemorrhage (PPH) contributes to approximately 25% of maternal death globally. Tranexamic acid (TXA) has been confirmed to be effective in reducing post-partum blood loss, thereby preventing PPH and its possible sequelae. This clinical controlled trial compared the efficacy of a single dose of 0.5g of intravenous TXA to a single dose of 1g of intravenous TXA in prevention of primary PPH among high-risk parturient women in a teaching hospital. A total of 308 women served as the study sample; 154 women were randomly selected to be administered with 0.5g of tranexamic acid (study group), while the remaining 154 respondents were administered with 1g of tranexamic acid (control group). Post-partum blood loss was monitored immediately. All results were recorded in a proforma. Data were coded and entered into Statistical Package for the Social Sciences (SPSS) version 23. Continuous variables were presented as mean ± Standard deviation while categorical data such as frequency tables and percentages. Student’s t-test was used as appropriate for statistical significance. Results were considered statistically significant when P< 0.05. The mean blood loss of 475.79ml was higher in the study group compared to the mean blood loss of 430.18ml in the control group, this was statistically significant, (t=2.401, p<0.05). In conclusion, the 1g of tranexamic acid is more effective in the prevention of PPH compared to the 0.5g of tranexamic acid. It was recommended that 0.5g of tranexamic can be administered in the face of challenges at obtaining the standard 1g doses of tranexamic acid. However, the 1g standard dose of tranexamic acid is still the recommended dose especially for high-risk patients

Comparative Study of Sublingual versus Rectal Route of Misoprostol Administration in Prevention of Primary Post-partum Haemorrhage in Women with Risk Factors in ESUT Teaching Hospital, Enugu, Nigeria

Background: Post-partum haemorrhage is a major cause of maternal death globally but more in low-income countries. While various studies recognized the efficacy of misoprostol in decreasing intraoperative blood loss, there is no consensus on the most effective route of administration of misoprostol. 
 Objective: This study compared the effect of sublingual misoprostol with rectal misoprostol in preventing primary post-partum haemorrhage in women with risk factor(s) to PPH. 
 Methodology: This is a comparative study that involved 200 participants who were randomized to two groups by 1:1 computer-based randomization (group A & group B). Each participant in group A received a 600mcg sublingual misoprostol plus rectal placebo, and participants in group B received a 600mcg rectal misoprostol plus sublingual placebo after delivery. The delivery mat already in use and soaked with liquor was removed once delivery was imminent, a new pre-weighed mat was replaced under the patient's buttocks, and also a pre-weighed sanitary pad was placed in her vulva to collect all the blood loss. The need for additional uterotonics and blood transfusion was assessed, and findings were documented appropriately in the proforma. Blood loss throughout a period of 24 hours after the delivery was measured by the gravimetric method. Weight gain from the sanitary pad/ delivery mat was calculated as 1g = 1 ml. The sanitary pad/mat was weighed in triplicate, and the mean of the three weights was entered into the database. The difference was the amount of blood loss, assuming 1g to be equivalent to 1 ml of blood. 
 Result: The median 24-hour post-partum blood loss was less in sublingual group when compared with the rectal group (110ml vs 170ml) P=0. 001.The mean post-partum Hb was higher in sublingual group 10.00±1.21 vs 9.00± 0.61 P=0.30. Both sublingual and rectal routes of misoprostol administration were effective in preventing PPH, P-value=1.0 and there was no indication for extra-uterotonic or blood transfusion.
 Conclusion: It is concluded that even though sublingually and rectally administered misoprostol showed equal efficacy in preventing PPH, sublingual route is associated with less blood loss.

Comparison the Effectiveness of Oxytocin and Misoprostol in Prevention of Primary Post-Partum Haemorrhage

Introduction: Postpartum haemorrhage is one of the leading causes of maternal mortality. Maternal Mortality globally is estimated as 599.00 deaths per year, a ratio of 400 maternal deaths per 10,000 live births. The aim of this study was to compare the effectiveness of oxytocin and misoprostol in prevention of primary post-partum haemorrhage Material and Method: It was Randomized Controlled Trial, which was conducted in the department of Obstetrics and Gynaecology, Hospital, Peshawar, between 14th March 2020 to 22 April 2022). The sample size was 100(50 in each group) Using 4% of PPH in misoprostol group, 24% of PPH in oxytocin group, 95% confidence level and 90% power of test under WHO software for sample size determination. Results: A total of 100 patients of primary post-partum haemorrhage were observed, which were divided in two equal groups A & B. Patients in Group A were managed with misoprostol while patients in group B will be subjected to oxytocin. Gravida wise distribution shows that out of 50 patients 22(44%) were gravid less than or equal to one,18(36) patient have 2-5 and 10(20%) were more than 5 while group B contains 25(50%) less than or equal to one, 17(34%) patients 2-5 and 8(16%) have gravid more than 5. Gravida distribution among the groups was insignificant with p-value=0.802. Average age was 27.82 years+4.56SD with range of 20-36 years. Group A contained 13(26%) patients in less than or equal to 25 years, 30(60%) patients 26-35 years and 7(14%) patients having ages of more than 35 years. While group B contained 18(36%) patients in less than or equal to 25 years, 28(56%) in 26-35 years and 4(8%) patients with age more than 35 years. The age distribution among the group was also insignificant with p-value 0.429. Efficacy wise distribution was significant with p-value = 0.021. Group A showed 47(94%) efficacy while non-effective in 3(6%) patients. Similarly, Group B showed 39 (78%) efficacy while non effective in 11(22%) patients. The misoprostol has greater efficacy than oxytocin. Age wise distribution of drug-efficacy shows that efficacy was almost same in all age groups. The patients having less than or equal to 25 years of age have shown efficacy in 12(92.3%) patients while 1(7.7%) patients being non-effective. Patients with 26-35 years of age have shown efficacy in 28(93.3%) of patients and 2(6.7%) have shown no efficacy. Similarly, 7(100%) patients have shown efficacy and no patients have no efficacy, with age more than 36 years of age. The same pattern was followed in group B, although age wise efficacy was insignificant in both the groups with p-value=0.765 and 0.987 respectively. The prevention of PPH, particularly in resource poor settings, where PPH is the leading cause of maternal mortality The enormity of postpartum haemorrhage and the limitations in the use of oxytocin for the adequate preventive therapy were the basic rationales behind this study. Secondarily, our cultural setups of home deliveries have a marked role in grave morbidity as well as lack a consensus protocol for the choice of adequate preventive treatment of haemorrhage. Keeping in view the above mentioned factors, this study was conducted to compare the effectiveness of the per rectal misoprostol medication to the intramuscular oxytocin to control the blood loss as adequate preventive therapy. Conclusion: Misoprostol is more effective as compared to oxytocin in prevention of primary postpartum hemorrhage. Keywords: Primary Postpartum haemorrhage, Cervical tears, Vaginal tears, oxytocin, Misoprostol, efficacy

Comparison of Oral Misoprostol with Intravenous Oxtocin in the Prevention of Primary Postpartum Haemorrhage in ESUT Teaching Hospital: A Randomized Controlled Trial

Background: Postpartum haemorrhage (PPH) is one of the major causes of maternal mortality globally. About 14 million patients suffer from postpartum haemorrhage annually worldwide, of which about 140,000 die. The active management of third stage of labour with the use of uterotonic drugs has reduced the risk of postpartum haemorrhage significantly. The most common uterotonic drug currently in use is oxytocin but the problem of insufficient skilled manpower for its administration, inadequacy of electric power supply to ensure the stability of the drug at appropriate temperature, and its high cost have made widespread use of oxytocin difficult in the resource-poor countries. This has made the search for an effective, affordable, stable and available alternative necessary. Misoprostol, an analogue of prostaglandin-E1, has a good uterotonic activity, is highly affordable, does not require specialized skill to administer and is very stable at room temperature. It also has multiple routes of administration, which makes its use in resource-poor countries indispensable. Aim: To determine if there is any difference in the efficacy of intravenous oxytocin over oral misoprostol in the prevention of primary postpartum haemorrhage. Study Design: This was a prospective, double-blinded, randomized study of uncomplicated pregnant women who had vaginal delivery in ESUT Teaching Hospital, Enugu. Sample Size: Two hundred (200) pregnant women who satisfied the inclusion criteria were recruited in this study with each arm of the study accommodating 100 participants. Methodology: The eligible women were recruited on presentation to the labour ward after giving their consent. They were randomly allocated into 2 groups: A and B. Group A received 2 tablets (400mcg) of oral misoprostol and 1mililtre (ml) of sterile water intravenously while group B received 2 tablets of white vitamin c and 1ml (10iu) of intravenous oxytocin immediately after cord clamping and cutting following the delivery of the baby. Pre-weighed delivery mats and vulval pads were used to collect the blood at delivery and for the first 24 hours for weighing and estimation of blood loss. A proforma was used to record the necessary data. Statistical Analysis: Data collected from the study was analyzed with the Statistical Package for Social Sciences (SPSS) computer software version 20.0 for windows. Statistical analysis was both descriptive and inferential at 95% confidence level. The socio-demographic variables were used to categorize the data and this was subjected to comparative statistical evaluation to yield frequencies, means, and percentages. Test of significance between class differences was by Pearson’s Chi-square test for categorical variables and student’s t-test for continuous variables. All P<0.05 at one degree of freedom (df=1) was considered statistically significant. Results: Two hundred pregnant women were recruited into the study with 100 women on each arm and all completed the study. The amounts of blood loss (in mililitre) in the misoprostol and oxytocin arms were 339.36 ± 122.28 and 378.52 ± 148.24, respectively. Forty-three women had PPH (blood loss ≥ 500ml) but there was no significant difference in the amount of blood loss and occurrence of PPH on both arms of the study. Conclusion: There was no difference in the efficacy of oxytocin over misoprostol in the management of the 3rd stage of labour for preventing PPH. We therefore, recommend that misoprostol can be adopted as an alternative/substitute to oxytocin in the management of the third stage of labour especially in the developing countries for prevention of PPH.

Intraoperative Blood Loss Reduction During Caesarean Delivery- Rectal Misoprostol Versus Oxytocin Infusion- A Randomized Controlled Trial

The first drug of choice recommended by the World Health Organization (WHO) for the prevention of primary postpartum haemorrhage during caesarean section is oxytocin. However, when oxytocin’s efficacy is questionable due to poor transportation, suboptimal storage and or adulteration as seen in developing countries, an adjunctive, synergistic and cheaper as well as temperature-stable, uterotonic such as misoprostol would be needed. The study was aimed at comparing the effectiveness of rectal misoprostol with that of oxytocin infusion in intraoperative blood loss reduction during caesarean section. The trial involved one hundred and forty pregnant women who had unequivocal indications for caesarean section and had risk factors for primary postpartum haemorrhage were randomized equally into two study groups, after informed consent. One study arm received adjunctive 40 IU of oxytocin infusion and the other arm received adjunctive 600 ug of rectally administered misoprostol, after clamping of the edges of the uterine wound with Green-Armytage forceps at caesarean section. The primary outcome measure was intraoperative blood during caesarean section. The statistical significance was set at p-value of 0.05. There was no statistically significant difference between the study groups in reduction of intraoperative blood loss during caesarean section (603.5 ± 153.8 ml vs 597.4 ± 200.9 ml, p= 0.839). It was concluded that rectally administered 600 ug misoprostol is an effective, non-inferior adjunctive uterotonic comparable to 40 IU oxytocin infusion in reducing intraoperative blood loss during caesarean section.

The Efficacy and Safety of Intrauterine Misoprostol During Cesarean Section in Prevention of Primary Post-Partum Hemorrhage - A Randomized Controlled Trial

Postpartum hemorrhage remains the most common cause of maternal death globally [1]. and has persisted in low-income countries due to the prevalence of home deliveries and limited access to life-saving uterotonic drugs in these countries [2-5]. Many of the global gains in reducing maternal mortality can be attributed to developments in preventing and treating Postpartum Hemorrhage (PPH) [6,7]. PPH is often associated with the failure of the uterus to contract after delivery and is categorized as blood loss of 500 mL or more following a vaginal delivery or 1,000 mL after cesarean delivery [8,9]. PPH is categorized as primary if it occurs within 24 hours of delivery and secondary if excessive blood loss occurs at 24 hours or more after delivery. To compare the efficacy and safety of intrauterine misoprostol with intravenous oxytocin during Cesarean Section (CS) in prevention of primary post-partum hemorrhage. A total of 150 pregnant women at term (37-40 weeks) gestation who were scheduled for either elective or emergency caesarean delivery were enrolled. They were equally randomized into two groups: women who received 400mcg intrauterine misoprostol in addition to intravenous infusion of 10 IU oxytocin as Group I while women who received an intravenous infusion of 10 IU oxytocin after delivery of the neonate as Group II. The Primary outcome measures were Estimated Blood Loss (EBL) during caesarean section and need for additional uterotonic drugs intraoperatively. Secondary outcomes included the occurrence of excessive blood loss (>1000mL) within the first 6 hours postoperatively and the occurrence of any maternal or fetal side effects. The difference in the postoperative haemoglobin and postoperative hematocrit was found to be highly significant between the two groups (10.12 ± 1.55 vs 9.24 ± 1.52; p < 0.01) and (2.48 ± 1.38 vs 3.75 ± 1.77; p < 0.001) respectively. Estimated blood loss in two groups was found to be very highly significant (440.19 ± 257.75 vs 677.38 ± 343.04; p < 0.001). Intraoperative blood loss was significantly lower in the group I compared to group II (408.27 ± 123.34 vs 486.04 ± 135.84; p < 0.001). Blood loss during the first 6 hours after delivery was also lower in the group I (58.87 ± 9.86 mL vs 63.29 ± 12.39 mL; p < 0.05). Fewer women in the intrauterine misoprostol group needed additional uterotonics (7 vs 11; p > 0.05). The difference in the side effects of both the groups was found to be statistically non-significant. Apgar scores at 1 and 5 minutes were comparable in both the groups. The combined use of intrauterine misoprostol (400 mg), when added to oxytocin infusion during caesarean section is effective in decreasing the intraoperative blood loss, post-operative blood loss and prevent postpartum hemorrhage. keywords: Intrauterine misoprostol; Intraoperative estimated blood loss; Cesarean section; Postpartum hemorrhage

Effects of multifaceted interventions to prevent and manage primary postpartum haemorrhage in referral hospitals: a quasi-experimental study in Nigeria

IntroductionPrimary postpartum haemorrhage (PPH) is the leading cause of Nigeria’s high maternal mortality rate. This study investigated the effectiveness of a set of multifaceted interventions to manage and reduce PPH...

Role of tranexamic acid in the prevention of primary postpartum haemorrhage.

Objectives: To determine the role of TRANEXAMIC ACID in prevention of primary postpartum haemorrhage in women. Study Design: Observational Retrospective Cohort Design. Settings: DHQ Hospital, Gujranwala. Period: April 2016 to July 2018. Material & Methods: The data of 110 women who suffered postpartum haemorrhage was retrieved from the hospital records. Exclusion criteria included all the females who were below and equal to 18 years of age. Patients suffering from acute respiratory distress syndrome (ARDS), on long-term anti-inflammatory and steroid therapy were also excluded. Whereas all the women who had experienced postpartum haemorrhage after birth were included. Results: We retrieved data of 110 women who had experienced postpartum haemorrhage after birth. The age of participants was averaged 28.95 + 7.6 years. The group I was named as early treatment group and contained 35 women whereas the group II (late treatment or without TRANEXAMIC ACID) had 75 women. The mean age of women is higher in the group I i.e. 30.2 +6.8 than 27.7+8.4. The TRANEXAMIC ACID was given intravenously with an average dose of 1 gram (0.1-3.0 grams) 1.5 hours after the birth. This was an average time for all cases in group I. The average time was 4.6 hours in group II. Conclusion: We concluded that use of intravenous TRANEXAMIC ACID in postpartum haemorrhage is associated with reduced haemorrhage but a low dose at early treatment may not yield good results.

Comparative Study between Oxytocin and Carbetocin for the prevention of Primary Postpartum Hemorrhage following Caesarean Section

Background & objective: Of the many pharmacological options for the management of postpartum hemorrhage, oxytocin is the first line of treatment. The newer drug carbetocin is getting popularity among obstetricians, although there is as yet not enough evidence about its safety and efficacy. The present study attempted to compare oxytocin with carbetocin for the routine prevention of postpartum hemorrhage (PPH) following caesarean section.
 Methods: The present comparative clinical trial was conducted in the Department of Obstetrics and Gynaecology in Rajshahi Medical College Hospital (RMCH), Rajshahi over a period of one year between March 2017 to February 2018. Pregnant women undergoing cesarean section under regional anaesthesia and do not have known hypersensitivity to oxytocin and carbetocin and known bleeding disorders were included in the study. A total of 96 such subjects were consecutively included and were randomly assigned to either Oxytocin (n = 48) and Carbetocin (n = 48) Groups. The outcome was evaluated in terms of incidence of PPH (loss of blood > 1000 ml), blood transfusion needed to compensate for lost blood, additional oxytocics needed to manage PPH and adverse effects encountered by the subjects.
 Result: The mean age of the subjects was around 25 years and the age distribution between the study groups was almost similar. In terms of obstetric characteristics multigravida was predominant in the Oxytocin group than that in the Carbetocin group. The current pregnancy profile like gestational age, ANC received, number of foetus in utero and placental position all were comparable between the groups. Antenatal conditions/diseases deemed to have influence on PPH were no different between the study groups. Past history of caesarean section was higher in Oxytocin group (43.8%) than that in the Carbetocin group (22.9%). There were negligible incidences of past PPH and myomectomy in either group. The mean haemoglobin level in the former and the latter groups were 9.5 and 10 gm/dl respectively with majority of the subjects being mildly anaemic. More than 80% of the subjects in either group underwent emergency caesarean section. The outcome showed that 83% in the Oxytocin group and 90% in the Carbetocin group did not develop PPH, but the difference was not significant. The mean blood lost was somewhat lower in the carbetocin group (630 ml) than that in the Oxytocin group (685 ml). The number of patients needed to be transfused and the mean amount of blood transfused to them in each group was fairly comparable. Oxytocin group received additional oxytocic drugs, such as, Metherspan and Misoprostol more frequently than the Carbetocin group did, but the differences did not turn significant. A few patients in both groups developed adverse effects but they were comparable. The mean 24-hours urine output was > 2000 ml in either group).
 Conclusion: The study concluded that the incidence of PPH, the amount of blood lost, number of patients transfused, amount of blood transfused and the additional amount of oxytocics required for the prevention and treatment of PPH were broadly comparable between the two study groups.
 Ibrahim Card Med J 2021; 11 (1): 71-78

Comparison of Efficacy of Refrigerated Oxytocin with Oxytocin Kept at Room Temperature for the Prevention of Post-Partum Haemorrhage in Vaginal Deliveries in a Tertiary Care Setting

Introduction: Postpartum haemorrhage is one of the leading causes of maternal death worldwide and it accounts for nearly one-quarter of all maternal deaths and almost half of all postpartum deaths in low-income countries. Primary postpartum haemorrhage (PPH) is the most common form of major obstetric haemorrhage. Materials and Methods: The study protocol was comprised of Consent, Measurement of Pre-delivery Hemoglobin, Administration of the Intervention, Measurement of postpartum blood loss and Measurement of Post-delivery (24-48 hours) Hemoglobin. Blood loss was measured using a calibrated drape. The drape was placed beneath the parturient buttocks and secured around her abdomen with ties. Blood loss was monitored for a minimum of one hour and was continued in the second hour in case of persistent bleeding. The drape with the collected blood was weighed on a scale. The weight of the drape and the container in which it is placed was deducted from the total recorded weight in order to obtain the weight of the blood collected in the drape. Blood loss weight in grams was converted to milliliters by dividing the figure in grams by 1.06 (blood density in grams per milliliter). Results: The cross tabulations were used to study the demographic, obstetrical and medical factors in women with obstetrical haemorrhage. Table 1 shows the selected sociodemographic characteristics of the study population. The mean age of cases and controls are 26.333.559 and 26.853.873 respectively. On comparison, they are statistically insignificant. (p=0.324). The educational, occupational and socioeconomic status was comparable between cases and controls (p >0.05). Table 2 shows Antenatal, intra-partum and post-partum data in cases and controls. Discussion & Conclusion: It is a study done in North India comparing the Oxytocin kept at room temperature with failure of maintenance of cold chain during transport and storage and the refrigerated Oxytocin. It is the common understanding and general training that Oxytocin must be stored in the refrigerator, failing which its efficacy reduces i.e. it, will not be effective in controlling PPH. During the study we compared the mean blood loss and change in hemoglobin levels in cases and control and despite the fact that major risk factor for PPH for example past history of PPH, past history of D&C, prolonged third stage labour duration, manual removal of placenta were comparable in both cases and controls, still the mean blood loss and change in hemoglobin values was more in cases than controls. This could be attributed to usage of market oxytocin which had failed cold chain maintenance resulted in less effective oxytocin in prevention of PPH, Hence causing more blood loss and drop in hemoglobin values. This shows the need of room temperature stable uterotonic drug in LMIC’s like ours. Recently room temperature stable carbetocin shows the potential as an effective uterotonic drug for the prevention of PPH. However according to various studies carbetocin cannot be used for induction or augmentation of labour so it cannot replace oxytocin fully, rather it acts as a part of collective PPH reduction strategy

325The incidence of primary postpartum haemorrhage following in-hospital birth: a systematic review and meta-analysis

Abstract Background Although primary postpartum haemorrhage is a leading cause of maternal mortality, in the wider literature, there is inconsistent results in studies about its incidence. This study was designed to determine the pooled incidence of primary postpartum haemorrhage among women following in-hospital births. Methods This review used a systematic review and meta-analysis approach. We systematically searched electronic databases of Ovid MEDLINE, Ovid Emcare, Embase, PsycINFO, and CINAHL. Studies reporting the incidence of primary postpartum haemorrhage following in-hospital births were included. The pooled incidence of primary postpartum haemorrhage with a 95% confidence interval was calculated using random-effects model. Heterogeneity test between studies, and publication bias were assessed with I-square statistics and Egger’s test respectively. Results Ten of the 1548 studies were found to be eligible and were included in this systematic review and meta-analysis. The pooled incidence of primary postpartum haemorrhage following in-hospital births was nearly 12% (95% CI: 7.74- 17.61), with no evidence of between studies heterogeneity. Conclusions The incidence of primary postpartum haemorrhage following in-hospital births was high, and suggest that preventive strategies implemented to reduce its occurrence needs further strengthening using training. Key messages The result of this review suggests that globally at least one in ten women experience a primary postpartum haemorrhage following in-hospital births. This is higher than anticipated. The application of the recommended strategies for the prevention of primary postpartum haemorrhage should be re-emphasized.

Intramuscular oxytocin versus Syntometrine® versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double-blinded clinical trial of effectiveness, side effects and quality of life.

To compare intramuscular oxytocin, Syntometrine® and carbetocin for prevention of postpartum haemorrhage after vaginal birth. Randomised double-blinded clinical trial. Six hospitals in England. A total of 5929 normotensive women having a singleton vaginal birth. Randomisation when birth was imminent. Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, adverse effects, quality of life. Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (odds ratio [OR] 1.28, 95% CI 1.08-1.51, P=0.004); the difference between carbetocin and oxytocin was non-significant (P=0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P=0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0.64, 95% CI 0.42-0.97) but not carbetocin (P=0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal adverse effects and reduced ability of the mother to bond with her baby. Non-inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal adverse effects are a disadvantage of Syntometrine. IM carbetocin does not reduce additional uterotonic use compared with IM Syntometrine or oxytocin.

Carbetocin Versus Oxytocin in Cesarean Section For Prevention of Primary Postpartum Hemorrhage

Carbetocin Versus Oxytocin in Cesarean Section For Prevention of Primary Postpartum Hemorrhage

Randomized controlled trial comparing 400μg sublingual misoprostol versus placebo for prevention of primary postpartum hemorrhage.

Introductionobstetric hemorrhage is estimated to cause 25% of all maternal deaths and is the leading direct cause of maternal mortality worldwide. The World Health Organization recommended the use of uterotonics that should be offered for all women who will give birth but in some countries or in special situations oxytocin is not available. The goal of this study is to determine whether the 400μg dose of Misoprostol decreases the incidence of postpartum hemorrhage (PPH) of women who did not show signs of hemorrhage.Methodsa prospective randomized double blind controlled trial was conducted between February 2012 and June 2012, among women in the active stage of labor attending the Obstetric Gynecology Department, University Hospital Farhat Hached of Sousse, Tunisia. Women with term singleton pregnancies greater than 32 weeks of amenorrhea with anticipated vaginal delivery were eligible for the study. Participants were randomly assigned to receive 400 μg sublingual Misoprostol or 2 ets of placebo immediately after cord clamping. The primary outcome measures were an estimation of blood loss including the subjective finding of vaginal hemorrhage > 500 ml, the decrease of hemoglobin and hematocrit, a change in hemodynamic parameters, and the need for additional dose of oxytocin. Secondary outcomes were occurrence of possible side effects such as: headache, nausea, vomiting, pyrexia, diarrhea and abdominal pain.Resultsa total of 211 patients were randomized: 111 in the Misoprostol group (Cytotec*) and 100 patients in the placebo group. The two groups were similar in terms of sociodemographic characteristics. Significant difference between the 400-μg of Misoprostol and placebo group were recorded in mean postpartum blood and PPH occurrence. The difference in pre- and postpartum hemoglobin loss (expressed in grams per 100 ml) was 1.21 ± 1.05 for the Misoprostol group and 1.51 ± 0.74 for the placebo group with significant difference (p = 0.02). No differences were observed in the occurrence of headache, dizziness, vomiting, diarrhea and metallic taste but the incidence of shivering was more than twice as great among women receiving Misoprostol than among those treated with placebo with a significant difference (p = 0.01). Similarly, women who received Misoprostol had a significantly higher mean temperature after delivery in comparison with those receiving placebo.Conclusionmisoprostol, administered as 400 μg after delivery, appears to be effective for the prevention of post-partum hemorrhage, but its side effects appears to be significant.

Randomised Controlled Trial of Sublingual and Rectal Misoprostol in the Prevention of Primary Postpartum Haemorrhage in a Resource-Limited Community.

Misoprostol is beneficial in preventing postpartum haemorrhage (PPH). However, there is no consensus yet as to which route will give the balance of efficacy, safety and patient preference, especially at the recommended dose of 600 mcg. This study compared the efficacy and adverse effects of rectal and sublingual misoprostol for the prevention of PPH. In a prospective fashion, consenting eligible parturients were randomised into two groups to receive either 600 mcg of misoprostol rectally or sublingually after vaginal delivery. All study participants were followed up till 24h postpartum. Primary outcomes were blood loss of 500ml or greater and at least 10% change in peripartum haematocrit levels. Seven (6.7%) and 16 (15.7%) of the sublingual and rectal routes, respectively, had PPH. However, the odds of having PPH after rectal misoprostol were at least twice the odds after the sublingual route (p = 0.041). Also, the mean blood loss after the first, fourth and 24th hour postpartum were significantly higher after rectal administration. Although significantly more patients had shivering and pyrexia after sublingual misoprostol, it was acceptable to more participants than the rectal route. At the recommended dose, sublingually administered misoprostol ('the sweet of life') is associated with a lower incidence of PPH than the rectal route. Despite its higher incidence of shivering and pyrexia, it was accepted by more women than rectally administered misoprostol.ClinicalTrials.gov identifier PACTR201911500348367.

Evaluation of the oxytocin use in the active management of third stage of labour among Sudanese women: a prospective, hospital-based study

Background: Active management of third stage of labour (AMTSL) by administration of prophylactic uterotonic drugs immediately after delivery can reduce the rate of postpartum haemorrhage (PPH). This study aimed to evaluate oxytocin use in the prevention of primary PPH at Omdurman Maternity Hospital, Khartoum, Sudan.

A double-blind randomized controlled clinical trial of oral misoprostol versus ergometrine in the prevention of primary postpartum hemorrhage

Objective: The study was designed to investigate the effectiveness of orally administered misoprostol versus intravenous ergometrine (stored at tropical temperatures) in the prevention of primary postpartum hemorrhage (PPH) among parturients undergoing vaginal delivery in a teaching hospital.Study Design: A double-blind randomized controlled clinical trial was conducted at the University of Benin Teaching Hospital. One hundred and fifty parturients were offered 400 ug misoprostol and an intravenous placebo for the management of the third stage of labor while another 150 parturients received oral placebo and 0.5 mg intravenous ergometrine.Results: There was no significant difference in the incidence of PPH (blood loss > 500 ml) between the two groups: 8 (5.3%) for the misoprostol group compared with 7 (4.7%) for the ergometrine group (P = 0.79, relative risk (RR) = 1.07, confidence interval (CI): 0.66–1.74). The incidence of severe PPH (blood loss > 1000 ml) was similar between the two groups: 2 (1.3%) in the misoprostol group compared with 1 (0.7%) in the ergometrine group. Similarly, the indices of postpartum blood loss (hematocrit change, need for blood transfusion, and surgical intervention) were comparable between the two groups. A subgroup analysis of high-risk parturients revealed comparable indices. The misoprostol group, however, had a significantly higher risk of shivering in the early postpartum period (P = 0.00, RR = 2.01, CI: 1.69–2.38).Conclusions: The results suggest that oral misoprostol has comparable efficacy to intravenous ergometrine at tropical conditions in the prevention of PPH. However, in view of its easier mode of administration, oral misoprostol may be preferable in rural situations in Africa.

Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study)

BackgroundPostpartum haemorrhage remains a major cause of maternal mortality and morbidity worldwide. Active management of the third stage of labour reduces the risk of postpartum haemorrhage. Oxytocin and oxytocin/ergometrine are commonly used in the UK, with oxytocin/ergometrine being more effective at preventing moderate, but not severe, blood loss. Many guidelines specifically recommend using oxytocin for all vaginal births, as it is associated with fewer adverse events. However, a survey conducted by the Southmead Hospital Maternity Research Team revealed that 71.4% of UK obstetric units still routinely use oxytocin/ergometrine. Carbetocin is a newer medication that may be as effective but has fewer side effects. No studies have directly compared all three medications.MethodsThe IMox study aims to determine the most effective, acceptable and cost-effective drug for primary prevention of postpartum haemorrhage following vaginal birth. The IMox study is a prospective, multi-centre, double-blind, randomised trial directly comparing oxytocin, oxytocin/ergometrine and carbetocin given intramuscularly for the prevention of postpartum haemorrhage in the third stage of labour. The primary effectiveness outcome is the use of an additional uterotonic drug. Secondary effectiveness outcomes reflect maternal morbidity and mortality within the immediate postpartum period. Participant questionnaires and subjective reporting of side effects will be used to evaluate maternal acceptability. Maternal quality of life utilities will be collected antenatally, and on days 1 and 14 after birth to enable a cost-effectiveness assessment of each studied drug.Participants will be pregnant women planning a vaginal birth in six hospitals in England. Participants will be approached and invited to provide consent to participate from 20 weeks gestation until in established labour. A complete sample of 5712 participants (1904 per arm) providing data for the primary outcome will allow for a robust determination of efficacy between all three study drugs. Data will be collected until participants are discharged from the hospital and on postnatal days 1 and 14 regardless of location. All analyses will be on a modified intention-to-treat basis, and additionally repeated on a per protocol basis. Data collection commenced in Feburary 2015 and was completed in August 2018.DiscussionThis study is the first to directly compare oxytocin, oxytocin/ergometrine and carbetocin in the same population for the prevention of postpartum haemorrhage following vaginal birth. Furthermore, this study will be the first to directly compute health economic outcomes from such a three-way comparison. This study is limited to using short-term outcomes, and so will not provide evidence for important outcomes such as long-term maternal psychological well-being and time to next conception.Trial registrationClinicalTrials.gov, NCT02216383. Registered on 18 August 2014. EudraCT, 2014-001948-37. Registered on 23 September 2014. ISRCTN, ISRCTN10232550. Retrospectively registered on 6 March 2018).

Tranexamic Acid versus Placebo for Prevention of Primary Postpartum Haemorrhage among High Risk Women Undergoing Caesarean Section in Abakaliki: A Randomized Controlled Trial

Objective: To evaluate the efficacy of tranexamic acid for prevention of postpartum haemorrhage among women undergoing cesarean section who were at high risk of postpartum hemorrhage. Materials and Method: This was a double blind randomized controlled trial conducted at the Alex Ekwueme Federal University Teaching Hospital Abakaliki from January 2016 to December 2017. One hundred and sixty-eight parturients at high risk of postpartum haemorrhage who underwent caesarean section were randomly assigned to receive either tranexamic acid or placebo prior to skin incision. Results: The result of the study showed that the need for additional uterotonic was higher in women in the placebo arm when compared with women in the tranexamic arm of the study (7.4% versus 33.3%, respectively). The incidence of primary post-partum hemorrhage (blood loss > 1000 ml) was significantly lower in the tranexamic acid group compared to placebo group (11.9% versus 50%, respectively, P-value < 0.0001). Conclusion: Intravenous tranexamic acid given prior to skin incision at caesarean section reduced the need for additional uterotonics and incidence of primary postpartum among high risk women.