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Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04833556
Enrollment
649
Registered
2021-04-06
Start date
2021-04-22
Completion date
2024-12-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Complication, Blood Transfusion Complication, Cesarean Section Complications, Postpartum Hemorrhage, Uterine Atony With Hemorrhage

Keywords

Cesarean section, Postpartum haemorrhage, Anesthesia complication, Blood transfusion, Intensive care unit admission

Brief summary

Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study 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.

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.

Interventions

None listed

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of blood transfusionIn operating theatre to 24 hour postoperativelyRate of blood transfusion in patients with postpartum haemorrhage
Rate of ICU admissionFrom 0-24 hours postoperativelyPatients with postpartum haemorrhage required admission in the ICU

Secondary

MeasureTime frameDescription
Anesthetic techniqueIn operating theatre to 24 hour postoperativelyGeneral anesthesia with endotracheal tube or regional anesthesia
Rate of blood component administrationIn operating theatre to 24 hour postoperativelyRate of patients receiving FFP, cryoprecipitate or platelets
Rate of Tranexamic acid administrationIn operating theatre to 24 hour postoperativelyRate of patients receiving Tranexamic acid
Causes of postpartum hemorrhageIn operating theatre to 24 hour postoperativelyIdentify causes of postpartum hemorrhage
Amount of haemorrhageIn operating theatre to 24 hour postoperativelyAmount of blood loss after delivery
Rate of complications after postpartum haemorrhage0-30 days postoperativelyRate of complications after postpartum haemorrhage eg. prolong intubation, congestive heart failure, acute kidney injury, transfusion-related acute lungs injury (TRALI)
Maternal mortality rate0-30 days postoperativelyReport rate of maternal death
Neonatal outcomesAt 1 and 5 minutes after deliveryNeonatal Apgar score
Factor associated ICU admissionIn operating theatre to 24 hour postoperativelyFactor associated ICU admission after cesarean delivery with postpartum hemorrhage
Rate of hysterectomyIn operating theatre to 24 hour postoperativelyRate of hysterectomy after postpartum hemorrhage

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026