## Protocol Section
### Identification Module
**NCT ID:** NCT06431204

**Brief Title:** Obstetric Comorbidity Index in Postpartum Hemorrhage

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

#### Organization Study ID Info
**ID:** 351/2567(IRB2)
#### Organization
**Class:** OTHER
**Full Name:** Mahidol University
#### Secondary ID Infos
**Domain:** Siriraj Institutional Review Board
**ID:** Si 359/2024
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mahidol University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Cesarean Section Complications

- Postpartum Hemorrhage

- Morbidity;Perinatal

**Keywords:**

- cesarean section

- postpartum hemorrhage

- maternal morbidity

- obstetrics comorbidity index

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 576

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications)

**Intervention Names:**

- Other: Obstetric comorbidity index

**Label:** Patients with postpartum hemorrhage with severe maternal morbidity

#### Arm Group 2

**Description:** Patients without the severe maternal morbidity conditions

**Intervention Names:**

- Other: Obstetric comorbidity index

**Label:** Patients with postpartum hemorrhage without severe maternal morbidity

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients with postpartum hemorrhage with severe maternal morbidity

- Patients with postpartum hemorrhage without severe maternal morbidity

**Description:** Obstetric comorbidity index score

**Name:** Obstetric comorbidity index

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** The prediction of severe maternal morbidity using obstetric comorbidity index

**Time Frame:** in 72 hours after cesarean delivery

#### Secondary Outcomes

**Description:** Perioperative red blood cells transfusion in units

**Measure:** Rate of blood transfusion

**Time Frame:** in 72 hours after cesarean delivery

**Description:** Quantity of postpartum hemorrhage in ml.

**Measure:** Quantity of postpartum hemorrhage

**Time Frame:** in 24 hours after cesarean delivery

**Description:** Main cause of postpartum hemorrhage

**Measure:** Cause of postpartum hemorrhage

**Time Frame:** in 24 hours after cesarean delivery

**Description:** Rate of intensive care unit admission

**Measure:** Rate of ICU admission

**Time Frame:** in 24 hours after cesarean delivery

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

**Measure:** Rate of Postoperative complications

**Time Frame:** in 72 hours after cesarean delivery

**Description:** Neonatal Apgar score from 0 - 10

**Measure:** Neonatal Apgar score

**Time Frame:** at 1-minute and 5-minute after delivery

**Description:** Maternal death rate

**Measure:** Rate of maternal mortality

**Time Frame:** in 72 hours after cesarean delivery

### Eligibility Module

**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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** patchareya.niv@gmail.com

**Name:** Patchareya Nivatpumin, M.D.

**Phone:** +66896662187

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bangkok Noi

**Contacts:**

***Contact 1:***

- **Email:** patchareya.niv@mahidol.ac.th

- **Name:** Patchareya Nivatpumin, M.D.

- **Phone:** +66896662187

- **Role:** CONTACT

**Country:** Thailand

**Facility:** Faculty of Medicine Siriraj Hospital

**State:** Bangkok

**Zip:** 10700

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND

**Name:** Patchareya Nivatpumin, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** We may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from our hospital director.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000011644

- Term: Puerperal Disorders

- ID: D000014592

- Term: Uterine Hemorrhage

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M9556

- Name: Hemorrhage

- Relevance: HIGH

- As Found: Hemorrhage

- ID: M9559

- Name: Postpartum Hemorrhage

- Relevance: HIGH

- As Found: Postpartum Hemorrhage

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14499

- Name: Puerperal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17340

- Name: Uterine Hemorrhage

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006473

- Term: Postpartum Hemorrhage

- ID: D000006470

- Term: Hemorrhage

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
