Comparison of tranexamic acid plus intramuscular oxytocin with intramuscular oxytocin alone for prophylaxis of primary postpartum haemorrhage in vaginal delivery

Sukanya Singh; Surekha Tayade

doi:10.12688/f1000research.140734.1

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Study Protocol

Comparison of tranexamic acid plus intramuscular oxytocin with intramuscular oxytocin alone for prophylaxis of primary postpartum haemorrhage in vaginal delivery

[version 1; peer review: 1 approved with reservations]

Sukanya Singh ¹, Surekha Tayade¹

PUBLISHED 29 Dec 2023

Author details Author details

¹ Obstetrics and Gynaecology, Jawaharlal Nehru Medical College , Sawangi (M), Wardha, Wardha, Maharashtra, India

Sukanya Singh
Roles: Data Curation, Investigation, Methodology, Resources, Software, Writing – Original Draft Preparation

Surekha Tayade
Roles: Conceptualization, Formal Analysis, Project Administration, Supervision, Validation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

In contemporary obstetrics, postpartum hemorrhage is one of the primary causes of maternal mortality. Postpartum hemorrhage is defined as blood loss of more than 500 mL within the first 24 hours of birth. The term, late postpartum hemorrhage is used when the bleeding lasts more than 24 hours. Due to the physiological changes that occur during pregnancy, the body may sustain a 500 mL blood loss without experiencing any severe negative consequences. However, even a modest amount of blood loss might be harmful in cases of comorbidities like anemia. However, even a modest amount of blood loss might be harmful in cases of comorbidities like anemia. Postpartum hemorrhage poses a double threat because it decreases the mother's strength and immunity, leaving her more vulnerable to puerperal illnesses. Second, the loss of blood could be fatal. Maternal death occurs gradually as a result of constant trickle-like blood loss. There are predictors which may help us in scrutinizing patients to be labeled as high risk for postpartum hemorrhage, however, there are no formulized criteria for postpartum hemorrhage. The active management of the third stage of labor is a management protocol made to prevent as well as manage this potentially life-threatening condition. It has significantly led to a reduction in maternal mortality rates. However, with more permutation - combinations of medical management and using different pharmacological agents we can devise a better algorithm for further deduction in the mortality rates. Here we propose to randomly allocate and administer an additional drug, tranexamic acid, in addition to uterotonics prophylactically given during the active management of the third stage of labor in vaginal deliveries. In doing so we compare the differences between groups in which only oxytocin was given and in which oxytocin plus tranexamic acid was given.

Keywords

postpartum hemorrhage, prevention, tranexamic acid, vaginal delivery, maternal mortality

Corresponding author: Sukanya Singh

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Singh S and Tayade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Singh S and Tayade S. Comparison of tranexamic acid plus intramuscular oxytocin with intramuscular oxytocin alone for prophylaxis of primary postpartum haemorrhage in vaginal delivery [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1608 (https://doi.org/10.12688/f1000research.140734.1) First published: 29 Dec 2023, 12:1608 (https://doi.org/10.12688/f1000research.140734.1) Latest published: 29 Dec 2023, 12:1608 (https://doi.org/10.12688/f1000research.140734.1)

Introduction

The most common and serious consequence for mothers after giving birth is postpartum haemorrhage (PPH). Worldwide, pregnancy and childbirth-related factors account for the deaths of nearly five lakh women annually. Severe anaemia, the need for a blood transfusion, hospitalisation, and infection are some of the most common outcomes of PPH. Goal 5 of the Millennium Development Plan calls for a 75 percent drop in the maternal mortality rate by 2015, which equates to an annual drop of 5.5 percent.

In medical literature, PPH is elaborated as postpartum haemorrhage of 500 mL or greater blood loss.¹ Bleeding from or into the genital tract after delivery and before the end of puerperium is clinically defined as the quantity of bleeding that negatively affects the patient's overall state as demonstrated by rising pulse rate and lowering blood pressure.

There are two main categories:

• Primary: blood loss on the first day within 24 hrs after a baby's birth.
• Secondary: late or delayed haemorrhage is bleeding occurring post-24h but before the end of the puerperium.

Most cases of PPH may be traced back to uterine atony. Polyhydramnios, macrosomia, preeclampsia, preeclamptic pregnancies, protracted or augmented labour, numerous pregnancies, prior caesarean section, and a history of preeclampsia are all additional risk factors.²^,³ However, most patients with PPH had low-risk pregnancies and can't pinpoint any specific causes for their condition.⁴^,⁵ The prevalence of PPH was 9.2 percent among a sample of 1620 rural Indian women. Women with PPH did not vary from women without PPH in terms of maternal or socio-demographic variables.⁶ Therefore, preventing PPH in all women is crucial.⁷^–¹⁰

The first line of defence in the treatment of PPH is oxytocin. Ergometrine and carboprost and misoprostol administered intramuscularly and intravenously are two more methods. The well-established uterotonics, notably oxytocin, may be supplemented by the biochemical haemostatic impact of pro-haemostatic medicines like Tranexamic acid (TXA).¹¹ TXA may be given in a diverse range of healthcare settings, is cost-effective, and can minimise PPH and related morbidity and death in areas where tertiary obstetric care is unavailable. TXA has the potential to contribute to the objective of decreasing maternal mortality by lowering the likelihood of hysterectomy, the danger of severe anaemia, and blood transfusion requirements.

Rationale: A step closer to achieving the Millennium Development Goals for maternal health care during childbirth is by reducing the rates of maternal mortality and morbidity and by treating PPH. Uterotonics are advised for all pregnancies in order to reduce the risk of preeclampsia during the third stage of labour. Most preventative measures are carried out within the crucial window of placental expulsion for PPH prevention. The only portion of active management of third stage of labour which has proven to reduce the risk of postpartum haemorrhage is postpartum treatment with uterotonics, and more specifically oxytocin.¹²^–¹⁶ According to a recent systematic review and mathematical model, the preventative or therapeutic use of TXA for PPH might save about 22,000 fatalities annually throughout the world (assuming a 30 percent effect size). By using this study, we can infer valuable information which will help obstetricians if additional use of tranexamic acid along with intramuscular oxytocin should be used prophylactically for prevention of primary PPH.

Aim

The study is aimed to estimate if the prophylactic administration of tranexamic acid along with intramuscular oxytocin is linked to improvement in Primary Postpartum Haemorrhage, mortality and morbidity and the negative effects linked to its uses in vaginal delivery.

Objective

Primary objectives

1. To determine the efficacy of tranexamic acid as an add therapy to intramuscular oxytocin in reducing blood loss in vaginal delivery.
2. To compare the two groups of tranexamic acid plus intramuscular oxytocin in one arm versus intramuscular oxytocin in another arm.

Secondary objectives:

1. To determine need for blood transfusion.
2. To determine need for additional uterotonics.
3. To determine the side effects.

Protocol

Methods: Participants, interventions, and outcomes

Study setting: Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital.

Eligibility criteria: Inclusion Criteria:

1. Scheduled or unscheduled vaginal delivery of all age groups and parity
2. Singleton or twin gestation

Exclusion criteria:

Severe surgical and medical complications

• Past allergy with tranexamic acid
• Thrombi-embolic disorders history.
• Antenatal conditions such as abnormal placenta
• Placenta abruption, Placenta-previa, severe preeclampsia, adherent placenta, macrosomia, multiple pregnancies, polyhydramnios,

Gynaecological or Fibroid uterus disorders that can complicates the pregnancy.

Interventions description:

After receiving institutional ethics committee permission, we began the research. Women who meet the eligibility requirements will be educated about the study's purpose and requested to sign an informed consent form in the Marathi language before being enrolled. Demographic characteristics, obstetric history and medical history will be noted.

In this study, 55 subjects would be administered Intramuscular Oxytocin 10 units, during of birth of new-born’s anterior shoulder (control group) and 55 women would be administered Oxytocin 10 units, along-with Injection Tranexamic acid, 1g diluted in 100mL solution of lactated ringers (LR), intravenously during the birth of a new-born’s anterior shoulder (experimental group). The subjects would be unaware about the allocation as the allocation would be randomised. The amount of blood loss would be accessed. The blood loss will be estimated by using Brass v drape and the amount of blood suctioned by suction machine. Pre delivery and post-delivery haemoglobin, morbidity and mortality and side effects will be compared in both groups.

Outcomes:

Primary outcome measures

1. Different groups as per blood loss:
- • Women receiving only oxytocin
- • Women receiving oxytocin and tranexamic acid

Secondary outcome measures

2. Difference in Post-delivery (up to 6 hours) in the same two groups of:
- • Haemoglobin/haematocrit
- • Additional uterotonics requirement
- • Blood transfusion requirement
3. Side effects related to drug used.

Participant timeline: Patients visiting Acharya Vinoba Bhave Rural Hospital for vaginal delivery during two years.

Sample size:

The SPSS 16.0 application is used for necessary statistical analysis. Age, weight, blood loss, and labours will all be measured to determine their respective means and standard deviations. For determining whether there is a statistically significant difference among the two groups in terms of the continuous variables used to measure blood loss and labour time, an unpaired t-test will be performed. The chi-square test will be used for comparing two groups statistically for higher blood loss (>500ml) and a drop in haemoglobin of >10%. The significance level selected must correspond to a probability value of p≤0.05.

The major factor will be the frequency with which each group has a decrease in haemoglobin of more than 10% and how those percentages compare to one another. Due to the small sample size, we recommend using an alpha error of 0.01. The sample size formula is as follows:

Cochran formula for sample size:

n = 2 α / 2^{2} . p . (1 - p) / E^{2}

Where,

$2 α / 2^{2} :$ Significance Level = 1.96 (5% i.e., 95% confidence interval)

p = incidence of PPH = 7% = 0.07

E = Error of Margin desired = 7% = 0.07

n = {1.96}^{2} \times 0.07 \times (1 - 0.07) / {0.07}^{2} = 51.03

n = 55

Recruitment:

The term patients visiting Acharya Vinoba Bhave Rural Hospital for vaginal delivery as per our inclusion criteria will be encouraged to participate in the study. Patients will be explained about the drug and its intervention during normal delivery.

Methods: Assignment of interventions

Allocation by computer-generated random numbers. Allocation concealment mechanism is not applicable. The participants will enrol willingly after fulfilling the inclusion criteria. The allocations will be done the principal investigator with. Guidance from study supervisor. Blinding of the trial participants will be done.

Data collection, management, and analysis

The amount of blood loss would be accessed. The blood loss will be estimated by using Brass v drape and the amount of blood suctioned by suction machine. The data collection will be one time intervention hence patient compliance and follow up will not be an issue.

Pre delivery and post-delivery haemoglobin, morbidity and mortality and side effects will be compared in both groups in tabulated format. Range checks for data values will be assessed by the principle investigation. A self-administered questionnaire will be filled by the patient at the time of discharge.

Dissemination

The study's output will result in articles that are published in indexed journals.

Study status

The investigations and data collections are yet to begin.

Discussion

When dealing with patients who are experiencing life-threatening bleeding, time is of the importance. Common cause of maternal death is bleeding after giving birth. Every six minutes, a mother dies from postpartum bleeding somewhere in the globe.¹⁷ Postpartum haemorrhage is a prominent cause of maternal mortality worldwide, especially in high-income nations, despite the fact that most of the fatalities happen in low- and middle-income regions. FDPs, especially D-dimers, a biomarker of fibrinolysis, are increased in women with postpartum haemorrhage.¹⁸^,¹⁹ By inhibiting plasmin's enzymatic action on fibrin, tranexamic acid provides an alternative approach of maintaining haemostasis; nonetheless, postpartum haemorrhage can still be treated with current pharmacological and surgical techniques. Women with postpartum haemorrhage might benefit from tranexamic acid because of its ability to lessen bleeding after surgery. There are two major reasons why tranexamic acid is so crucial. To begin, PPH is the primary reason of mortality for new mothers. More than half of all haemorrhage-related maternal fatalities happen within eight hours after giving delivery.²⁰ Many women who may have benefitted from therapy will perish in the meantime. Second, administering tranexamic acid as soon as possible maximises its efficacy.

Since tranexamic acid is inexpensive, heat stable, and commercially accessible in large quantities, it should be kept on hand at all times at obstetric emergency care facilities.

For the therapy of postpartum haemorrhage, tranexamic acid must be utilised in addition to all standard medical (uterotonics), surgical and non-surgical therapies. Some infusion solutions, such as those containing carbohydrates, electrolytes, dextran amino and acids, may be combined with it; however, solutions containing blood for transfusion, penicillin, or mannitol should not. Women who have had a previous thromboembolic event, are hypersensitive to tranexamic acid, have current intravascular clotting, or have a history of coagulopathy are not eligible for anti-fibrinolytic medication.

Most women in high-income nations give birth in hospitals or have access to ambulance services, allowing medical professionals to quickly treat postpartum haemorrhage with intravenous tranexamic acid. About 40% of women in poor and middle-income nations give birth at home due to no or limited means of transportation. Medical professionals are present for most deliveries, but they aren't trained to provide IV medications. Women often lose consciousness during the lengthy hospital transport that follows. Medics should learn how to inject oxytocin subcutaneously and intravenously. This therapy has the potential to save lives in the community, meaning more women will have access to it sooner. Since tranexamic acid has a broad therapeutic index, it may be administered intravenously after an initial intramuscular injection.

Women are more likely to survive postpartum haemorrhage now than ever before because of advancements in urgent obstetric care, particularly using tranexamic acid as first-line treatment. Moreover, postpartum haemorrhage is becoming increasingly common.²¹^–²³ The number of women who suffer from the psychological and bodily aftereffects of PPH as a result will rise accordingly. Risk aspects for maternal morbidity after PPH and strategies for reducing these risks require more study.²⁴

Ethical considerations

ICE approval received from the Datta Meghe Institute of Higher Education & Research (Ref No. DMIHER (DU)/IEC/2023/798)

Date: 21/03/2023

Data availability

Currently no data is associated with this article as this is a study protocol.

Reporting guidelines

Zenodo: SPRIT checklist for ‘Comparison of Tranexamic Acid plus Intramuscular Oxytocin with Intramuscular Oxytocin alone for prophylaxis of Primary Postpartum Haemorrhage in vaginal delivery’, DOI.: https://doi.org/10.5281/zenodo.8206239

License: Creative Commons Attribution 1.0 Generic

Acknowledgements

We acknowledge the support of the statistician for the valuable feedback.

References

1. World Health Organization: Managing complications in pregnancy and childbirth. Geneva: World Organization; 2000.
2. Kramer MS, Berg C, Abenhaim H, et al.: Incidence, risk factors, and temporal trends in severe postpartum hemorrhage. Am. J. Obstet. Gynecol. 2013; 209(449): 449.e1–449.e7. Publisher Full Text
3. Bateman BT, Berman MF, Riley LE, et al.: The epidemiology of postpartum hemorrhage in a large, nationwide sample of deliveries. Anesth. Analg. 2010; 110: 1368–1373. PubMed Abstract | Publisher Full Text
4. Mathai M, Gülmezoglu AM, Hill S: Saving womens lives: Evidence-based recommendations for the prevention of postpartum haemorrhage. Bull. World Health Organ. 2007; 85: 322–323. PubMed Abstract
5. McCormick ML, Sanghvi HCG, Kinzie B, et al.: Preventing postpartum hemorrhage in low-resource settings. Int. J. Gynaecol. Obstet. Off. Organ. Int. Fed. Gynaecol. Obstet. 2002; 77: 267–275. Publisher Full Text
6. Geller SE, Goudar SS, Adams MG, et al.: Factors associated with acute postpartum haemorrhage in low-risk women delivering in rural India. Int. J. Gynecol. Obstet. 2008; 101(1): 94–99. PubMed Abstract | Publisher Full Text | Free Full Text
7. Goffinet F, Mercier F, Teyssier V, et al.: Postpartum haemorrhage: recommendations for clinical practice by the CNGOF (December 2004). Gynecol. Obstet. Fertil. 2005; 33: 268–274. PubMed Abstract | Publisher Full Text
8. American College of Obstetricians and Gynecologists: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet. Gynecol. 2006; 108: 1039–1047.
9. Royal College of Obstetricians and Gynaecologists: Prevention and management of postpartum haemorrhage. Guidelines no 52. London: RCOG; 2009.
10. World Health Organization: Recommendations for the prevention and treatment of postpartum haemorrhage. WHO; 2012.
11. Begley CM, Gyte GML, Devane D, et al.: Active versus expectant management for women in the third stage of labour. Cochrane Database Syst. Rev. 2015; 3: CD007412. PubMed Abstract | Publisher Full Text
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14. Gülmezoglu AM, Lumbiganon P, Landoulsi S, et al.: Active management of the third stage of labour with and without controlled cord traction: a randomised, controlled, non-inferiority trial. Lancet. 2012; 379: 1721–1727. PubMed Abstract | Publisher Full Text
15. Lalonde A, Daviss BA, Acosta A, et al.: Postpartum hemorrhage today: ICM/FIGO initiative 2004–2006. Int. J. Gynaecol. Obstet. Off. Organ Int. Fed. Gynaecol. Obstet. 2006; 94: 243–253. PubMed Abstract | Publisher Full Text
16. Hofmeyr GJ, Abdel-Aleem H, Abdel-Aleem MA: Uterine massage for preventing postpartum haemorrhage. Cochrane Database Syst. Rev. 2013; 2016: CD006431. Publisher Full Text
17. Say L, Chou D, Gemmill A, et al.: Global causes of maternal death: a WHO systematic analysis. Lancet Glob. Health. 2014; 2: e323–e333. Publisher Full Text
18. Bonnar J, Davidson JF, Pidgeon CF, et al.: Fibrin degradation products in normal and abnormal preg- nancy and parturition. Br. Med. J. 1969; 3: 137–140. Publisher Full Text
19. Ducloy-Bouthors AS, Duhamel A, Kipnis E, et al.: Postpartum haemorrhage related early increase in D-dimers is inhibited by tranexamic acid: haemostasis parameters of a randomized controlled open labelled trial. Br. J. Anaesth. 2016; 116: 641–648. PubMed Abstract | Publisher Full Text
20. Brenner A, Ker K, Shakur-Still H, et al.: Tranexamic acid for post-partum haemorrhage: What, who and when.Best Pract. Res. Clin. Obstet. Gynaecol.2019; 61: 66–74. PubMed Abstract | Publisher Full Text | Free Full Text
21. Kramer MS, Berg C, Abenhaim H, et al.: Incidence, risk factors, and temporal trends in severe postpartum hemorrhage. Am. J. Obstet. Gynecol. 2013; 209: 449.e1–449.e7. PubMed Abstract | Publisher Full Text
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23. Lutomski J, Byrne B, Devane D, et al.: Increasing trends in atonic postpartum haemorrhage in Ireland: an 11-year population-based cohort study. BJOG An. Int. J. Obstet. Gynaecol. 2012; 119: 306–314. Publisher Full Text
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Version 1

VERSION 1 PUBLISHED 29 Dec 2023

Author details Author details

¹ Obstetrics and Gynaecology, Jawaharlal Nehru Medical College , Sawangi (M), Wardha, Wardha, Maharashtra, India

Sukanya Singh
Roles: Data Curation, Investigation, Methodology, Resources, Software, Writing – Original Draft Preparation

Surekha Tayade
Roles: Conceptualization, Formal Analysis, Project Administration, Supervision, Validation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 29 Dec 2023, 12:1608

https://doi.org/10.12688/f1000research.140734.1

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© 2023 Singh S and Tayade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Singh S and Tayade S. Comparison of tranexamic acid plus intramuscular oxytocin with intramuscular oxytocin alone for prophylaxis of primary postpartum haemorrhage in vaginal delivery [version 1; peer review: 1 approved with reservations]. F1000Research 2023, 12:1608 (https://doi.org/10.12688/f1000research.140734.1)

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Reviewer Report 13 Mar 2024

Ritu Singh, All India Institute of Medical Sciences, Patna, India; Obstetric and Gynecology, Kurji Holy Family Hospital (Ringgold ID: 28703), Patna, Bihar, India

Approved with Reservations

https://doi.org/10.5256/f1000research.154121.r240831

1. Rationale of the study is clearly explained
2. Study design - not mentioned
3.Method details-
a. Not mentioned - how authors will see efficacy of the drugs?
b. Authors are going to do haemoglobin test ... Continue reading

1. Rationale of the study is clearly explained
2. Study design - not mentioned
3.Method details-
a. Not mentioned - how authors will see efficacy of the drugs?
b. Authors are going to do haemoglobin test in both group within 6 hours? We will do haemoglobin routinely the next day of delivery. Is it a hospital policy of the author to do haemoglobin within 6 hour or she will do it specifically in their study participants?
c. You are using it in active management, if PPH occurs what will you do - not mentioned.
d. In eligibility criteria not mentioned- is she taking term patient or preterm.
e. Will you be going to take all the patients visiting to hospital? She has written Principal investigator will do allocation - will she be available 24 x7 in the hospital?
f. How allocation and blinding will be done - not mentioned clearly
g. Self-administered questionaries - not mentioned

4. Aims, objective and outcome measures are not aligned
a. In Aims written- linked to improvement in PPH - how you are going to do it
b. In the Aim section of the author -it is written- “linked to improvement in Primary Postpartum Haemorrhage, mortality and morbidity and the negative effects linked to its uses in vaginal delivery’’.
Is author going to see mortality also, it is not mentioned in material methods
c. What negative effects - not mentioned.
d. Primary objectives are ‘’ 1. To determine the efficacy of tranexamic acid as an add therapy to intramuscular oxytocin in reducing blood loss in vaginal delivery.2. To compare the two groups of tranexamic acid plus intramuscular oxytocin in one arm versus intramuscular oxytocin in another arm’’
In this way the author will see efficacy – what parameters she will include not mentioned in material methods. How she will compare the two groups not mentioned.
e. Secondary objective- what side affects you are going to observe - not mentioned. There are many side effects of any drug, what side effects the author is going to see, they have to specify it.
f. Are you going to use suction cannula also. (as you have mentioned suction machine) Is it not a con founding factor, as suction cannula is itself is used in PPH management.

5.In Abstract-
a. Author sentence is “The term, late postpartum haemorrhage is used when the bleeding lasts more than 24 hours.’’
It should be- The term, late postpartum haemorrhage is used when the bleeding occurs after 24 hours till puerperium.
b. 'However, even a modest amount of blood loss might be harmful in cases of comorbidities like anaemia.’ This sentence is written twice

6. In Introduction-a it is not consequences - it is a complication.
b. Reference-not mentioned in 1st paragraph.
c. "Bleeding from or into the genital tract after delivery and before the end of puerperium is clinically defined as the quantity of bleeding that negatively affects the patient's overall state as demonstrated by rising pulse rate and lowering blood pressure."- sentence not correct
d. Preeclampsia and preeclamptic pregnancies are same
e It is not numerous - it is multiple pregnancies
f. Prevalence 9.2 percent - reference?
g. In introduction- Last paragraph is “The first line of defence in the treatment of PPH is oxytocin. Ergometrine and carboprost and misoprostol administered intramuscularly and intravenously are two more methods.”
In this sentence there are not only two more,’ ergometrine, carboprost, misoprostol ' are 3 drugs. It should be –are other methods- not two more methods
h. In rationale- reference for systemic review

7. In Discussion
Have to write points relevant to your study, no other details.
8. Need gross editing

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: I am a obstetric and gynecologist, a minimal invasive surgeon.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Ritu Singh, All India Institute of Medical Sciences, Patna, India; Kurji Holy Family Hospital (Ringgold ID: 28703), Patna, India

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Reviewer Report

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13 Mar 2024 | for Version 1

Ritu Singh, All India Institute of Medical Sciences, Patna, India; Obstetric and Gynecology, Kurji Holy Family Hospital (Ringgold ID: 28703), Patna, Bihar, India

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Approved With Reservations

1. Rationale of the study is clearly explained
2. Study design - not mentioned
3.Method details-
a. Not mentioned - how authors will see efficacy of the drugs?
b. Authors are going to do haemoglobin test in both group within 6 hours? We will do haemoglobin routinely the next day of delivery. Is it a hospital policy of the author to do haemoglobin within 6 hour or she will do it specifically in their study participants?
c. You are using it in active management, if PPH occurs what will you do - not mentioned.
d. In eligibility criteria not mentioned- is she taking term patient or preterm.
e. Will you be going to take all the patients visiting to hospital? She has written Principal investigator will do allocation - will she be available 24 x7 in the hospital?
f. How allocation and blinding will be done - not mentioned clearly
g. Self-administered questionaries - not mentioned

4. Aims, objective and outcome measures are not aligned
a. In Aims written- linked to improvement in PPH - how you are going to do it
b. In the Aim section of the author -it is written- “linked to improvement in Primary Postpartum Haemorrhage, mortality and morbidity and the negative effects linked to its uses in vaginal delivery’’.
Is author going to see mortality also, it is not mentioned in material methods
c. What negative effects - not mentioned.
d. Primary objectives are ‘’ 1. To determine the efficacy of tranexamic acid as an add therapy to intramuscular oxytocin in reducing blood loss in vaginal delivery.2. To compare the two groups of tranexamic acid plus intramuscular oxytocin in one arm versus intramuscular oxytocin in another arm’’
In this way the author will see efficacy – what parameters she will include not mentioned in material methods. How she will compare the two groups not mentioned.
e. Secondary objective- what side affects you are going to observe - not mentioned. There are many side effects of any drug, what side effects the author is going to see, they have to specify it.
f. Are you going to use suction cannula also. (as you have mentioned suction machine) Is it not a con founding factor, as suction cannula is itself is used in PPH management.

5.In Abstract-
a. Author sentence is “The term, late postpartum haemorrhage is used when the bleeding lasts more than 24 hours.’’
It should be- The term, late postpartum haemorrhage is used when the bleeding occurs after 24 hours till puerperium.
b. 'However, even a modest amount of blood loss might be harmful in cases of comorbidities like anaemia.’ This sentence is written twice

6. In Introduction-a it is not consequences - it is a complication.
b. Reference-not mentioned in 1st paragraph.
c. "Bleeding from or into the genital tract after delivery and before the end of puerperium is clinically defined as the quantity of bleeding that negatively affects the patient's overall state as demonstrated by rising pulse rate and lowering blood pressure."- sentence not correct
d. Preeclampsia and preeclamptic pregnancies are same
e It is not numerous - it is multiple pregnancies
f. Prevalence 9.2 percent - reference?
g. In introduction- Last paragraph is “The first line of defence in the treatment of PPH is oxytocin. Ergometrine and carboprost and misoprostol administered intramuscularly and intravenously are two more methods.”
In this sentence there are not only two more,’ ergometrine, carboprost, misoprostol ' are 3 drugs. It should be –are other methods- not two more methods
h. In rationale- reference for systemic review

7. In Discussion
Have to write points relevant to your study, no other details.
8. Need gross editing

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

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I am a obstetric and gynecologist, a minimal invasive surgeon.

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Comparison of tranexamic acid plus intramuscular oxytocin with intramuscular oxytocin alone for prophylaxis of primary postpartum haemorrhage in vaginal delivery

Abstract

Keywords

Introduction

Aim

Objective

Protocol

Methods: Participants, interventions, and outcomes

Methods: Assignment of interventions

Data collection, management, and analysis

Dissemination

Study status

Discussion

Ethical considerations

Data availability

Reporting guidelines

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