Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

Overview

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.

Full Title of Study: “Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2022

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.

Arms, Groups and Cohorts

  • Postpartum haemorrhage
    • Patients undergoing cesarean delivery with postpartum haemorrhage (blood loss more than or equal to 1,000 ml.)

Clinical Trial Outcome Measures

Primary Measures

  • Rate of blood transfusion
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Rate of blood transfusion in patients with postpartum haemorrhage
  • Rate of ICU admission
    • Time Frame: From 0-24 hours postoperatively
    • Patients with postpartum haemorrhage required admission in the ICU

Secondary Measures

  • Amount of haemorrhage
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Amount of blood loss after delivery
  • Rate of hysterectomy
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Rate of hysterectomy after postpartum hemorrhage
  • Anesthetic technique
    • Time Frame: In operating theatre to 24 hour postoperatively
    • General anesthesia with endotracheal tube or regional anesthesia
  • Rate of blood component administration
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Rate of patients receiving FFP, cryoprecipitate or platelets
  • Rate of Tranexamic acid administration
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Rate of patients receiving Tranexamic acid
  • Causes of postpartum hemorrhage
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Identify causes of postpartum hemorrhage
  • Factor associated ICU admission
    • Time Frame: In operating theatre to 24 hour postoperatively
    • Factor associated ICU admission after cesarean delivery with postpartum hemorrhage
  • Rate of complications after postpartum haemorrhage
    • Time Frame: 0-30 days postoperatively
    • Rate of complications after postpartum haemorrhage eg. prolong intubation, congestive heart failure, acute kidney injury, transfusion-related acute lungs injury (TRALI)
  • Maternal mortality rate
    • Time Frame: 0-30 days postoperatively
    • Report rate of maternal death
  • Neonatal outcomes
    • Time Frame: At 1 and 5 minutes after delivery
    • Neonatal Apgar score

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patchareya Nivatpumin, M.D., Principal Investigator, Mahidol University
  • Overall Contact(s)
    • Patchareya Nivatpumin, M.D., +6689-666-2187, patchareya.niv@mahidol.ac.th

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.