Obstetric Comorbidity Index in Postpartum Hemorrhage

NCT06431204 | Completed DMC

• 2 other identifiers: 351/2567(IRB2)Si 359/2024
• Study Type: observational
• Target: 583
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to examine the predictive capability of the Obstetric comorbidity index in the identification of severe maternal morbidity associated with postpartum hemorrhage in patients undergoing cesarean delivery.

Conditions

Cesarean Section Complications; Postpartum Hemorrhage; Morbidity;Perinatal

Keywords

cesarean section; postpartum hemorrhage; maternal morbidity; obstetrics comorbidity index

Outcome Measures

Primary Outcomes (1)

• The prediction of severe maternal morbidity using obstetric comorbidity index

  The prediction of severe maternal morbidity using obstetric comorbidity index presented in C-statistic (AUC of ROC)

  in 72 hours after cesarean delivery

Secondary Outcomes (7)

• Rate of blood transfusion

  in 72 hours after cesarean delivery

• Quantity of postpartum hemorrhage

  in 24 hours after cesarean delivery

• Cause of postpartum hemorrhage

  in 24 hours after cesarean delivery

• Rate of ICU admission

  in 24 hours after cesarean delivery

• Rate of Postoperative complications

  in 72 hours after cesarean delivery

Study Arms (2)

Patients with postpartum hemorrhage with severe maternal morbidity

Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications)

Other: Obstetric comorbidity index

Patients with postpartum hemorrhage without severe maternal morbidity

Patients without the severe maternal morbidity conditions

Other: Obstetric comorbidity index

Interventions

Obstetric comorbidity index OTHER

Obstetric comorbidity index score

Patients with postpartum hemorrhage with severe maternal morbidity; Patients with postpartum hemorrhage without severe maternal morbidity

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

The chart of patients who underwent cesarean delivery with the diagnosis of postpartum hemorrhage (bleeding \>, = 1,000 ml) and gestational age of more than 24 weeks.

You may qualify if:

• The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)

You may not qualify if:

• Cesarean delivery at less than 24 weeks of gestation
• A patient chart that does not contain primary outcome data eg. absence of anesthetic record
• Blood loss less than 1,000 ml in the first 24 hours postpartum

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

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

Study Officials

• Patchareya Nivatpumin, M.D.

  Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: July 13, 2024
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)