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Research Article | Volume 30 Issue 8 (August, 2025) | Pages 91 - 96
To Compare the Effectiveness and Safety of Heat-Stable Carbetocin Versus Oxytocin in the Prevention of Postpartum Hemorrhage (PPH) Following Cesarean Section.
 ,
 ,
1
PG Resident 3rd Year, Dept. of Obstetrician Gynecology, Amaltas Institute of Medical Sciences, Dewas, M.P.
2
Professor, Dept. of Obstetrician Gynecology, Amaltas Institute of Medical Sciences, Dewas, M.P.
3
Associate Professor, Dept. of Obstetrician Gynecology, Amaltas Institute of Medical Sciences, Dewas, M.P.
Under a Creative Commons license
Open Access
Received
July 1, 2025
Revised
Aug. 5, 2025
Accepted
Aug. 8, 2025
Published
Aug. 10, 2025
Abstract

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.

Keywords
INTRODUCTION

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.

MATERIALS AND METHODS

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:

  1. Group C: Received 100 μg heat-stable carbetocin intravenously.
  2. Group O: Received 10 IU oxytocin intravenously.

 

The respective interventions were administered immediately after delivery during the active management of the third stage of labor as per WHO guidelines.

 

Inclusion Criteria:

  1. Obstetric patients aged 18–45 years.
  2. Patients undergoing elective or emergency cesarean section.
  3. Patients willing to participate and provide written informed consent.

 

Exclusion Criteria:

  1. Patients with preeclampsia or other hypertensive disorders of pregnancy.
  2. Patients with pre-existing cardiac, renal, or liver diseases.
  3. Patients with epilepsy or requiring general anesthesia.
  4. Patients with a known hypersensitivity to carbetocin or oxytocin.
RESULTS

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.

DISCUSSION

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].

 

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.

REFERENCES
  1. Evensen A, Anderson JM, Fontaine P. Postpartum Hemorrhage: Prevention and Treatment. Am Fam Physician 2017;95(7):442–9.
  2. Alonso-Burgos A, Díaz-Lorenzo I, Muñoz-Saá L, Gallardo G, Castellanos T, Cardenas R, et al. Primary and secondary postpartum haemorrhage: a review for a rationale endovascular approach. CVIR Endovasc [Internet] 2024;7(1):17. Available from: https://doi.org/10.1186/s42155-024-00429-7
  3. Giouleka S, Tsakiridis I, Kalogiannidis I, Mamopoulos A, Tentas I, Athanasiadis A, et al. Postpartum Hemorrhage: A Comprehensive Review of Guidelines. Obstet Gynecol Surv [Internet] 2022 [cited 2024 Jul 12];77(11):665–82. Available from: https://journals.lww.com/obgynsurvey/fulltext/2022/11000/postpartum_hemorrhage__a_comprehensive_review_of.17.aspx
  4. Carroli G, Cuesta C, Abalos E, Gulmezoglu AM. Epidemiology of postpartum haemorrhage: a systematic review. Best Pract Res Clin Obstet Gynaecol 2008;22(6):999–1012.
  5. Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, et al. Global causes of maternal death: A WHO systematic analysis. Lancet Glob Heal 2014;2(6).
  6. Larciprete G, Montagnoli C, Frigo M, Panetta V, Todde C, Zuppani B, et al. Carbetocin versus oxytocin in caesarean section with high risk of post-partum J Prenat Med 2013;7(1):12–8.
  7. Borruto F, Treisser A, Comparetto C. Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trial. Arch Gynecol Obstet 2009;280(5):707–12.
  8. Samimi M, Imani-Harsini A, Abedzadeh-Kalahroudi M. Carbetocin vs. Syntometrine in Prevention of Postpartum Hemorrhage: a Double Blind Randomized Control Trial. Iran Red Crescent Med J 2013;15(9):817–22.
  9. El Behery MM, El Sayed GA, El Hameed AAA, Soliman BS, Abdelsalam WA, Bahaa A. Carbetocin versus oxytocin for prevention of postpartum hemorrhage in obese nulliparous women undergoing emergency cesarean delivery. J Matern Neonatal Med [Internet] 2016;29(8):1257–60. Available from: http://dx.doi.org/10.3109/14767058.2015.1043882
  10. Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, et al. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med 2018;379(8):743–52.
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