CClinicalTrials.gg
CompletedNCT06431204Updated Oct 2, 2025

Obstetric Comorbidity Index in Postpartum Hemorrhage

An observational study in Cesarean Section Complications, Postpartum Hemorrhage and Morbidity;Perinatal, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to female participants. Per ClinicalTrials.gov, last updated 2025-10-02.

Sponsored by Mahidol University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
583
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cesarean Section Complications
  • Postpartum Hemorrhage
  • Morbidity;Perinatal

Browse trials for

Keywords

  • cesarean section
  • postpartum hemorrhage
  • maternal morbidity
  • obstetrics comorbidity index
03

In context

Postpartum Hemorrhage

445 studies on the registry are indexed under Postpartum Hemorrhage; 75 are open to participants now.

This study's enrollment of 583 is above the median of 150 across 91 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)

Exclusion criteria

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
583 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

    Other: Obstetric comorbidity index

  • Patients with postpartum hemorrhage without severe maternal morbidity

    Patients without the severe maternal morbidity conditions

    Other: Obstetric comorbidity index

Interventions

  • OtherObstetric comorbidity index

    Obstetric comorbidity index score

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: in 72 hours after cesarean delivery

Secondary outcomes

  1. Rate of blood transfusion

    Perioperative red blood cells transfusion in units

    Time frame: in 72 hours after cesarean delivery

  2. Quantity of postpartum hemorrhage

    Quantity of postpartum hemorrhage in ml.

    Time frame: in 24 hours after cesarean delivery

  3. Cause of postpartum hemorrhage

    Main cause of postpartum hemorrhage

    Time frame: in 24 hours after cesarean delivery

  4. Rate of ICU admission

    Rate of intensive care unit admission

    Time frame: in 24 hours after cesarean delivery

  5. Rate of Postoperative complications

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

    Time frame: in 72 hours after cesarean delivery

  6. Neonatal Apgar score

    Neonatal Apgar score from 0 - 10

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

  7. Rate of maternal mortality

    Maternal death rate

    Time frame: in 72 hours after cesarean delivery

07

Study locations

1 site
  • Faculty of Medicine Siriraj Hospital
    Bangkok, 10700, Thailand
08

References and documents

Individual participant data

Plan to share: No — The investigators may balance the potential benefits and risks for each request and then provide the data that could be shared, together with the permission from the hospital director.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06431204
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
May 28, 2024
Start date
Jul 13, 2024
Primary completion
Sep 26, 2025
Completion
Sep 26, 2025
Last update
Oct 2, 2025

Study contacts

Patchareya Nivatpumin, M.D.
principal investigator · Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion