Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833556
• Other study ID #: 005/2564 (IRB4)
• Secondary ID: 161/2021
• Status: Recruiting
• Start date: April 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Mahidol University
• Contact: Patchareya Nivatpumin, M.D.
• Phone: +6689-666-2187
• Email: patchareya.niv[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Complication
• Blood Transfusion Complication
• Cesarean Section Complications
• Hemorrhage
• Postpartum Hemorrhage
• Transfusion Reaction
• Uterine Atony With Hemorrhage
• Uterine Inertia

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

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