Background & Methods: The aim of the study is to compare the effectiveness and safety of heat-stable carbetocin versus oxytocin in the prevention of postpartum hemorrhage (PPH) following cesarean section. Compilation and validation of collected data. Statistical analysis to compare outcomes between the two groups. Preparation of the final research report and dissemination of findings. Results: The need for additional uterotonic agents. In the carbetocin group, only 4.76% of women required additional uterotonics, compared to 14.3% in the oxytocin group. This difference was statistically significant (p = 0.003), indicating better effectiveness of carbetocin in reducing the need for further uterotonics. Conclusion: The age distribution was similar in both groups, with most participants between 21 to 30 years of age. The mean age was slightly lower in the carbetocin group. The gestational age at delivery was comparable in both groups, with most deliveries occurring between 37 and 41 weeks. Emergency caesarean sections were more common than elective procedures in both groups. The incidence of postpartum haemorrhage was significantly lower in the carbetocin group, suggesting better preventive efficacy. Women in the carbetocin group had lower volume of blood loss compared to those in the oxytocin group. The need for additional uterotonic agents was significantly lower in the carbetocin group, indicating greater clinical effectiveness.
Postpartum hemorrhage (PPH) is a significant obstetric complication characterized by excessive bleeding after childbirth. It is defined as blood loss exceeding 500 mL following a vaginal delivery or more than 1000 mL following a cesarean section[1]. PPH is further classified into primary and secondary types, based on the timing of onset. Primary PPH occurs within the first 24 hours postpartum and is often associated with uterine atony, trauma, or retained placental fragments. Secondary PPH presents after the initial 24-hour period but within six weeks of delivery. Causes include retained products of conception, subinvolution of the placental site, or infection[2].
The effects of PPH extend beyond immediate blood loss, with consequences that can lead to severe morbidity and mortality[3]. Acute blood loss can result in hypovolemic shock, a critical condition that deprives organs of adequate blood supply, potentially leading to multi-organ failure. In the absence of prompt intervention, maternal death may ensue. For survivors, PPH carries the risk of long-term health complications. Chronic anemia resulting from blood loss can impair physical functioning, energy levels, and quality of life, while repeated blood transfusions, often necessary in cases of severe PPH, carry risks of infection and immune sensitization[4]. Additionally, the psychological impact of a traumatic birth experience can lead to postpartum depression, anxiety, and even post-traumatic stress disorder, further affecting maternal well-being.
Globally, PPH remains a leading cause of maternal mortality and morbidity. According to the World Health Organization (WHO), PPH accounts for approximately 35% of all maternal deaths worldwide. The prevalence of PPH varies across regions, influenced by factors such as healthcare infrastructure, maternal health status, and the quality of obstetric care available[4]. In high-income countries, advancements in medical interventions have significantly reduced PPH-related deaths; however, in low- and middle-income regions, it continues to pose a critical risk to maternal health. In India, PPH is a major contributor to maternal mortality, responsible for around 38% of maternal deaths[4,5]. The burden is disproportionately high in rural and resource-limited settings where access to timely medical interventions is often restricted[4,5]. Socioeconomic factors, healthcare availability, and geographic barriers exacerbate the incidence and outcomes of PPH. Government initiatives and the National Health Mission have recognized the importance of addressing PPH, but further improvements in prevention, timely intervention, and access to uterotonic drugs are crucial.
The total duration of the present study was 18 months, divided into the following three phases. Development of the study protocol and tools, including consent forms and data collection templates. Submission and approval of the study by the Institutional Ethical Committee. Recruitment and training of research personnel including Principal Investigator.
Recruitment of eligible obstetric patients undergoing cesarean sections. Administration of the intervention (heat-stable carbetocin or oxytocin). Collection of demographic, clinical, and outcome data, including uterine tone, blood loss, and safety outcomes.
Study Groups: The participants were divided into two study groups:
The respective interventions were administered immediately after delivery during the active management of the third stage of labor as per WHO guidelines.
Inclusion Criteria:
Exclusion Criteria:
Table 1: Distribution of Participants based on Age |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Age Group |
|
|
|
|
18-20 |
26 |
15.5 |
15 |
8.93 |
21-25 |
54 |
32.1 |
62 |
36.9 |
26-30 |
56 |
33.3 |
59 |
35.1 |
31-35 |
32 |
19 |
32 |
19 |
Mean, SD |
24.5 |
2.2 |
25.4 |
2.4 |
The age distribution of the participants in both groups. Most women in the carbetocin group were aged between 26–30 years (33.3%), followed by 21–25 years (32.1%). A similar pattern was seen in the oxytocin group, where 36.9% of women were aged 21–25 years and 35.1% were in the 26–30 years age group. The mean age in the carbetocin group was 24.5 years (SD ±2.2), while in the oxytocin group it was 25.4 years (SD ±2.4).
Table 2: Distribution of Participants based on Gestational Age |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Gestational Age in Weeks |
|
|
|
|
37 |
28 |
16.7 |
31 |
18.5 |
38 |
29 |
17.3 |
30 |
17.9 |
39 |
26 |
15.5 |
23 |
13.7 |
40 |
33 |
19.6 |
29 |
17.3 |
41 |
25 |
14.9 |
31 |
18.5 |
42 |
27 |
16.1 |
24 |
14.3 |
The gestational age of participants at the time of delivery. In the carbetocin group, most deliveries occurred at 40 weeks (19.6%), followed by 38 weeks (17.3%). In the oxytocin group, 18.5% of women delivered at both 37 and 41 weeks. The distribution of gestational age was similar between the two groups.
Table 3: Distribution of Participants based on Type of C-section |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Type of C-section |
|
|
|
|
Emergency |
102 |
60.7 |
111 |
66.1 |
Elective |
66 |
39.3 |
57 |
33.9 |
The type of caesarean section performed. In the carbetocin group, 60.7% of women underwent emergency caesarean section, while 39.3% had elective procedures. In the oxytocin group, 66.1% had emergency caesarean section and 33.9% underwent elective surgery. Emergency procedures were more common in both groups.
Table 4: Incidence of Postpartum Haemorrhage |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Postpartum Haemorrhage |
|
|
|
|
No |
156 |
92.6 |
143 |
85.1 |
Yes |
12 |
7.4 |
25 |
14.9 |
|
Pearson chi2(1) = 7.51 P-value = 0.041 |
|
The incidence of postpartum haemorrhage. In the carbetocin group, 7.4% of women developed PPH, compared to 14.9% in the oxytocin group. This difference was statistically significant (p = 0.041), indicating that fewer women in the carbetocin group experienced PPH.
Table 5: Volume of Blood Loss |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Blood Loss Category |
|
|
|
|
501-600 |
37 |
22 |
13 |
7.74 |
601-700 |
56 |
33.3 |
45 |
26.8 |
701-800 |
38 |
22.6 |
33 |
19.6 |
801-900 |
23 |
13.7 |
50 |
29.8 |
901-1000 |
2 |
1.19 |
2 |
1.19 |
1001 - 1100 |
5 |
2.98 |
1 |
.595 |
1101 -1200 |
4 |
2.38 |
9 |
5.36 |
1201 - 1300 |
3 |
3.57 |
9 |
5.36 |
1301-1400 |
0 |
0.0 |
6 |
3.57 |
Pearson chi2(8) = 36.7890 P-value < 0.001 |
The volume of blood loss, in the carbetocin group, the highest proportion of women (33.3%) lost between 601–700 mL of blood. In contrast, 29.8% of women in the oxytocin group lost 801–900 mL of blood. More women in the oxytocin group had higher blood loss. This difference was statistically significant (p < 0.001).
Table 6: Distribution of Participants based on Need for Additional Uterotonic |
||||
|
CARBETOCIN (n=168) |
OXYTOCIN (n=168) |
||
|
n |
% |
n |
% |
Need for Additional Uretotonic |
|
|
|
|
No |
160 |
95.2 |
144 |
85.7 |
Yes |
8 |
4.76 |
24 |
14.3 |
|
Pearson chi2(1) = 8.8421 P-value = 0.003 |
|
||
|
|
|
|
|
The need for additional uterotonic agents. In the carbetocin group, only 4.76% of women required additional uterotonics, compared to 14.3% in the oxytocin group. This difference was statistically significant (p = 0.003), indicating better effectiveness of carbetocin in reducing the need for further uterotonics.
and effectiveness of heat-stable carbetocin and oxytocin in preventing postpartum bleeding after caesarean section. Postpartum haemorrhage is a major cause of maternal death in India. Quick and effective prevention is needed to reduce this risk[6]. Carbetocin is a newer drug with longer action. Oxytocin is the standard drug used in most hospitals. It is important to study if carbetocin works better and causes fewer side effects. This study gives useful data from a rural Indian setting where such information is limited.
The comparison of these two drugs is important for clinical practice. If carbetocin is more effective it can be used as a better option for managing third stage of labour especially in resource-limited areas. The findings from this study can guide treatment protocols and help reduce maternal complications. It also sets the base for more studies on this topic in different settings and among different groups of patients.
The following section compares the results of this study with findings from other recent similar studies.
In the present study, the incidence of postpartum haemorrhage (PPH) was significantly lower in the carbetocin group (7.4%) compared to the oxytocin group (14.9%) with a p-value of 0.041. This suggests that carbetocin is more effective than oxytocin in preventing PPH following caesarean section. This finding supports the use of carbetocin as a better uterotonic agent for the active management of the third stage of labour.
A similar trend was reported by Larciprete et al. (2013), where none of the women in the carbetocin group required additional uterotonics, while 23.5% in the oxytocin group did (p < 0.01)[7]. This shows a higher risk of uterine atony and bleeding in the oxytocin group. Borruto et al. (2009) also found that only 3.8% of women in the carbetocin group required additional uterotonic agents, compared to 9.6% in the oxytocin group (p < 0.01). These findings support the better uterine contractility and bleeding control with carbetocin[8].
El Behery et al. (2015) observed that none of the women in the carbetocin group experienced major PPH (>1000 mL), whereas 71.5% in the oxytocin group needed additional uterotonics (p < 0.01). They also reported better uterine tone at 2 and 12 hours in the carbetocin group. This matches the present study, where fewer women had PPH when given carbetocin[9-10].
The age distribution was similar in both groups, with most participants between 21 to 30 years of age. The mean age was slightly lower in the carbetocin group. The gestational age at delivery was comparable in both groups, with most deliveries occurring between 37 and 41 weeks.
Emergency caesarean sections were more common than elective procedures in both groups. The incidence of postpartum haemorrhage was significantly lower in the carbetocin group, suggesting better preventive efficacy. Women in the carbetocin group had lower volume of blood loss compared to those in the oxytocin group. The need for additional uterotonic agents was significantly lower in the carbetocin group, indicating greater clinical effectiveness.