Obstetric Comorbidity Index in Postpartum Hemorrhage

NCT ID: NCT06431204

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 583 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-13
• Study Completion Date: 2025-09-26

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.

Conditions

Cesarean Section Complications; Postpartum Hemorrhage; Morbidity;Perinatal

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

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)

Obstetric comorbidity index

Intervention Type: OTHER

Obstetric comorbidity index score

Patients with postpartum hemorrhage without severe maternal morbidity

Patients without the severe maternal morbidity conditions

Obstetric comorbidity index

Intervention Type: OTHER

Obstetric comorbidity index score

Interventions

Obstetric comorbidity index

Obstetric comorbidity index score

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patchareya Nivatpumin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND

Locations

Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Si 359/2024

Identifier Type: OTHER

Identifier Source: secondary_id

351/2567(IRB2)

Identifier Type: -

Identifier Source: org_study_id