Obstetric Comorbidity Index in Postpartum Hemorrhage

Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With Postpartum Hemorrhage

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Postpartum Hemorrhage; Morbidity;Perinatal
• Intervention / Treatment: Other: Obstetric comorbidity index

Detailed Description

The prospectively predictive maternal morbidity is imperative to enhance maternal outcomes. There has been development of the obstetric comorbidity index (OBCMI) by Bateman et al. in 2013 and performed with superior performance characteristics relative to general comorbidity measures in an obstetric population. The score has been a growing recognition of the necessity for specialized risk assessment tools tailored specifically to obstetric populations that differ from other populations. For instance, both the Charlson/Romano comorbidity index or the Elixhauser comorbidity score and their adaptations are deficient in accounting for obstetric conditions, thereby limiting their ability to predict obstetric morbidity or mortality.

The Obstetric Comorbidity Index has undergone thorough examination and validation across multiple nations. These findings collectively demonstrate the index's capacity for moderate to high predictive accuracy in anticipating maternal morbidities, accompanied by a commendable discriminative performance.

However, within the context of Thailand, investigations concerning the Obstetric Comorbidity Index and its association with perioperative complications or morbidities in postpartum hemorrhage patients undergoing cesarean delivery remain unexplored. Therefore, this study aims to elucidate the correlation between the Obstetric Comorbidity Index and severe maternal morbidity, while also scrutinizing the prevalence of comorbidities during the perioperative period among patients undergoing cesarean delivery at the largest University hospital, in THAILAND. Predicting the rate of maternal morbidity would be advantageous for facilitating preparation and augmenting awareness of complications during the perioperative period.

• Study Type: Observational
• Enrollment (Actual): 583

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Obstetric comorbidity index score
Patients with postpartum hemorrhage without severe maternal morbidity; Patients without the severe maternal morbidity conditions	Other: Obstetric comorbidity index; Obstetric comorbidity index score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of blood transfusion	Perioperative red blood cells transfusion in units	in 72 hours after cesarean delivery
Quantity of postpartum hemorrhage	Quantity of postpartum hemorrhage in ml.	in 24 hours after cesarean delivery
Cause of postpartum hemorrhage	Main cause of postpartum hemorrhage	in 24 hours after cesarean delivery
Rate of ICU admission	Rate of intensive care unit admission	in 24 hours after cesarean delivery
Rate of Postoperative complications	Post operative complications eg. congestive heart failure, TRALI, acute kidney injury	in 72 hours after cesarean delivery
Neonatal Apgar score	Neonatal Apgar score from 0 - 10	at 1-minute and 5-minute after delivery
Rate of maternal mortality	Maternal death rate	in 72 hours after cesarean delivery

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Patchareya Nivatpumin, M.D., Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2024
• Primary Completion (Actual): September 26, 2025
• Study Completion (Actual): September 26, 2025

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 28, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: cesarean section; postpartum hemorrhage; maternal morbidity; obstetrics comorbidity index
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage
• Other Study ID Numbers: 351/2567(IRB2); Si 359/2024 (Other Identifier: Siriraj Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from the hospital director.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No