Obstetric Comorbidity Index in Postpartum Hemorrhage

Recruiting

• Conditions: Postpartum Hemorrhage; Morbidity;Perinatal; Cesarean Section Complications
• Interventions: Other: Obstetric comorbidity index

• Registration Number: NCT06431204
• Lead Sponsor: Mahidol University

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.

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 Timeline

• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-24
• Study First Posted: 2024-05-28
• Study Start: 2024-07-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 576

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with postpartum hemorrhage with severe maternal morbidity	Obstetric comorbidity index	Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications)
Patients with postpartum hemorrhage without severe maternal morbidity	Obstetric comorbidity index	Patients without the severe maternal morbidity conditions

Primary Outcome Measures

Name	Time	Method
The prediction of severe maternal morbidity using obstetric comorbidity index	in 72 hours after cesarean delivery	The prediction of severe maternal morbidity using obstetric comorbidity index presented in C-statistic (AUC of ROC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand