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Completed

NCT Number: NCT06431204

Obstetric Comorbidity Index in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Obstetric comorbidity index

Other

Obstetric comorbidity index score

Primary outcomes

  1. The prediction of severe maternal morbidity using obstetric comorbidity index

    Time frame: in 72 hours after cesarean delivery

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

Secondary outcomes

  1. Rate of blood transfusion

    Time frame: in 72 hours after cesarean delivery

    Perioperative red blood cells transfusion in units

  2. Quantity of postpartum hemorrhage

    Time frame: in 24 hours after cesarean delivery

    Quantity of postpartum hemorrhage in ml.

  3. Cause of postpartum hemorrhage

    Time frame: in 24 hours after cesarean delivery

    Main cause of postpartum hemorrhage

  4. Rate of ICU admission

    Time frame: in 24 hours after cesarean delivery

    Rate of intensive care unit admission

  5. Rate of Postoperative complications

    Time frame: in 72 hours after cesarean delivery

    Post operative complications eg. congestive heart failure, TRALI, acute kidney injury

  6. Neonatal Apgar score

    Time frame: at 1-minute and 5-minute after delivery

    Neonatal Apgar score from 0 - 10

  7. Rate of maternal mortality

    Time frame: in 72 hours after cesarean delivery

    Maternal death rate

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 28, 2024
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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