- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833556
Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery
Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery
Study Overview
Status
Detailed Description
Postpartum hemorrhage (PPH) is the common cause of maternal death worldwide. It is interesting to note that PPH is the most common cause of death in developing country. Additionally, PPH is the common cause of maternal cardiac arrest. PPH defined as the amount of bleeding more than or equal to 500 ml after vaginal delivery and bleeding of more than or equal to 1,000 ml after cesarean delivery. The rate of PPH regardless any route of delivery was 2.9-3.2%. Rate of PPH in patients undergoing cesarean delivery was approximately 0.6% - 3.1%.
The difference in anesthetic techniques influence the rate of postpartum hemorrhage. Numerous studies showed the association between general anesthesia and postpartum hemorrhage in patient undergoing cesarean delivery. The outcome showed the odds of PPH in women who had cesarean delivery with general anesthesia were 8.15 times higher (95% CI 6.43-10.33) than for those who had CS with epidural anesthesia. Likewise, systematic review and meta-analysis revealed general anesthesia associated with higher amount of blood loss, but not the transfusion rate comparing with regional anesthesia. The decreasing of myometrial uterine tone from the usage of inhalational agents (halothane, enflurane, isofurane, sevoflurane, and desflurane) from general anesthesia explains this consequence.
Guidelines recommended the management of PPH after cesarean delivery were launched. World Health Organization (WHO) recommendation reported both surgical together with medical management (non-surgical) in patients with PPH, which published in the year 2012. The major role of anesthesiologists involving in treatment of PPH is medical treatment and blood and blood component administration. The novel medical treatment of PPH has been described in several literatures including the usage of tranexamic acid and fibrinogen concentrate. The World Maternal Antifibrinolytic trial (WOMAN trial) is the large-sample size randomized controlled trial publishing in the Lancet in the year 2017. WOMAN trial revealed the administration of tranexamic acid in patients with PPH after vaginal or cesarean delivery significantly reduced blood loss and decreased maternal mortality rate from bleeding. Likewise, Cochrane database systematic review concluded in the year 2018 that intravenous tranexamic acid reduced mortality rate due to bleeding in women with PPH, irrespective of mode of delivery. The WHO collaborator subsequently launched the update of recommendation including the administration of tranexamic acid 1 gram in PPH patients within 3 hours after birth.
Moreover, the rate of ICU admission after postpartum hemorrhage was studied revealing 15 of 21 patients (71.4%). Of which, 12 patients presented disseminated intravascular coagulation (DIC) and 2 cases death (9%). Critically-ill patients deriving from massive hemorrhage from PPH also transfusion-related acute lungs injury (TRALI), congestive heart failure, acute kidney injury and multiorgan failure.
In this study, we emphasize in patients underwent cesarean delivery with PPH (intraoperative estimated blood loss > 1,000 ml). The primary purpose is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
The detail of outcomes of PPH in cesarean delivered patients in Siriraj hospital is scared; and it has not yet been described in the literature. Therefore, the authors aim to collected the data and analyzed the outcomes associated with PPH, in order to report in the literatures as well as improving the anesthetic management of intraoperative PPH in our institute.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Exclusion Criteria:
- Cesarean delivery at less than 24 weeks of gestation
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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Postpartum haemorrhage
Patients undergoing cesarean delivery with postpartum haemorrhage (blood loss more than or equal to 1,000 ml.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of blood transfusion
Time Frame: In operating theatre to 24 hour postoperatively
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Rate of blood transfusion in patients with postpartum haemorrhage
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In operating theatre to 24 hour postoperatively
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Rate of ICU admission
Time Frame: From 0-24 hours postoperatively
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Patients with postpartum haemorrhage required admission in the ICU
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From 0-24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Amount of haemorrhage
Time Frame: In operating theatre to 24 hour postoperatively
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Amount of blood loss after delivery
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In operating theatre to 24 hour postoperatively
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Rate of hysterectomy
Time Frame: In operating theatre to 24 hour postoperatively
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Rate of hysterectomy after postpartum hemorrhage
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In operating theatre to 24 hour postoperatively
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Anesthetic technique
Time Frame: In operating theatre to 24 hour postoperatively
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General anesthesia with endotracheal tube or regional anesthesia
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In operating theatre to 24 hour postoperatively
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Rate of blood component administration
Time Frame: In operating theatre to 24 hour postoperatively
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Rate of patients receiving FFP, cryoprecipitate or platelets
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In operating theatre to 24 hour postoperatively
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Rate of Tranexamic acid administration
Time Frame: In operating theatre to 24 hour postoperatively
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Rate of patients receiving Tranexamic acid
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In operating theatre to 24 hour postoperatively
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Causes of postpartum hemorrhage
Time Frame: In operating theatre to 24 hour postoperatively
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Identify causes of postpartum hemorrhage
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In operating theatre to 24 hour postoperatively
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Factor associated ICU admission
Time Frame: In operating theatre to 24 hour postoperatively
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Factor associated ICU admission after cesarean delivery with postpartum hemorrhage
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In operating theatre to 24 hour postoperatively
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Rate of complications after postpartum haemorrhage
Time Frame: 0-30 days postoperatively
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Rate of complications after postpartum haemorrhage eg.
prolong intubation, congestive heart failure, acute kidney injury, transfusion-related acute lungs injury (TRALI)
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0-30 days postoperatively
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Maternal mortality rate
Time Frame: 0-30 days postoperatively
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Report rate of maternal death
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0-30 days postoperatively
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Neonatal outcomes
Time Frame: At 1 and 5 minutes after delivery
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Neonatal Apgar score
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At 1 and 5 minutes after delivery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patchareya Nivatpumin, M.D., Mahidol University
Publications and helpful links
General Publications
- Nivatpumin P, Nithi-Uthai J, Lertbunnaphong T, Sukcharoen N, Soponsiripakdee T, Yonphan P. Perioperative outcomes and causes of postpartum hemorrhage in patients undergoing cesarean delivery in Thailand: A comprehensive retrospective study. PLoS One. 2024 Apr 16;19(4):e0300620. doi: 10.1371/journal.pone.0300620. eCollection 2024.
- Nivatpumin P, Nithiuthai J, Lertbunnaphong T. The impact of the WOMAN trial on local clinical practice in Thailand. J Anesth. 2025 Oct;39(5):828-830. doi: 10.1007/s00540-025-03518-6. Epub 2025 Jun 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Female Urogenital Diseases and Pregnancy Complications
- Immune System Diseases
- Obstetric Labor Complications
- Pregnancy Complications
- Hemorrhage
- Hematologic Diseases
- Puerperal Disorders
- Uterine Hemorrhage
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Postpartum Hemorrhage
- Transfusion Reaction
Other Study ID Numbers
- 005/2564 (IRB4)
- 161/2021 (Registry Identifier: Siriraj Institutional Review Board COA number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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