Obstetric Comorbidity Index in Postpartum Hemorrhage

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431204
• Other study ID #: 351/2567(IRB2)
• Secondary ID: Si 359/2024
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: Patchareya Nivatpumin, M.D.
• Phone: +66896662187
• Email: patchareya.niv[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 576
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hemorrhage
• Morbidity;Perinatal
• Postpartum Hemorrhage

Intervention

Other:
• Obstetric comorbidity index
Obstetric comorbidity index score

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

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