Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery

NCT04833556 | Completed DMC

• 2 other identifiers: 005/2564 (IRB4)161/2021
• Study Type: observational
• Target: 649
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of blood transfusion

  Rate of blood transfusion in patients with postpartum haemorrhage

  In operating theatre to 24 hour postoperatively

• Rate of ICU admission

  Patients with postpartum haemorrhage required admission in the ICU

  From 0-24 hours postoperatively

Secondary Outcomes (10)

• Amount of haemorrhage

  In operating theatre to 24 hour postoperatively

• Rate of hysterectomy

  In operating theatre to 24 hour postoperatively

• Anesthetic technique

  In operating theatre to 24 hour postoperatively

• Rate of blood component administration

  In operating theatre to 24 hour postoperatively

• Rate of Tranexamic acid administration

  In operating theatre to 24 hour postoperatively

Study Arms (1)

Postpartum haemorrhage

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml

You may qualify if:

• Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml

You may not qualify if:

• Cesarean delivery at less than 24 weeks of gestation
• Patient chart that not contained primary outcome data eg. absent of the anesthetic record

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (2)

• 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.

  PMID: 38626161 RESULT

• 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.

  PMID: 40533618 RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage; Transfusion Reaction

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Patchareya Nivatpumin, M.D.

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 6, 2021
• Study Start: April 22, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

TH (1)