Cesarean Section ComplicationsNCT06431204
Obstetric Comorbidity Index in Postpartum Hemorrhage
An observational study of Cesarean Section Complications and Postpartum Hemorrhage, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section Complications, Postpartum Hemorrhage, Morbidity;Perinatal
- What is being tested?
- Obstetric comorbidity index
- How many people
- 583 participants
- Where
- 1 siteThailand
- Study dates
- 13 Jul 2024to 26 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With 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.
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.
- Being tested
- Obstetric comorbidity index
- Keywords
- cesarean section, postpartum hemorrhage, maternal morbidity, obstetrics comorbidity index
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric comorbidity indexOther
Obstetric comorbidity index score
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Obstetric comorbidity index | |
| Patients with postpartum hemorrhage without severe maternal morbidity | Patients without the severe maternal morbidity conditions Receives: Other: Obstetric comorbidity index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: in 72 hours after cesarean delivery
Secondary outcomes (7)
Rate of blood transfusion
Perioperative red blood cells transfusion in units
Measured: in 72 hours after cesarean delivery
Quantity of postpartum hemorrhage
Quantity of postpartum hemorrhage in ml.
Measured: in 24 hours after cesarean delivery
Cause of postpartum hemorrhage
Main cause of postpartum hemorrhage
Measured: in 24 hours after cesarean delivery
Rate of ICU admission
Rate of intensive care unit admission
Measured: in 24 hours after cesarean delivery
Rate of Postoperative complications
Post operative complications eg. congestive heart failure, TRALI, acute kidney injury
Measured: in 72 hours after cesarean delivery
Neonatal Apgar score
Neonatal Apgar score from 0 - 10
Measured: at 1-minute and 5-minute after delivery
Rate of maternal mortality
Maternal death rate
Measured: in 72 hours after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start13 Jul 2024
- Primary completion26 Sep 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431204
- Sponsor's protocol ID
- 351/2567(IRB2)
- Other IDs
- Si 359/2024
- Status last verified
- Sep 2025
- First submitted
- 17 May 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Comorbidity Index for Prediction of Perioperative Severe Maternal Morbidity in Patients Undergoing Cesarean Delivery With Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06431204
- Acronym / sponsor ID
- 351/2567(IRB2)
- Keywords
- cesarean section, postpartum hemorrhage, maternal morbidity, obstetrics comorbidity index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with postpartum hemorrhage with severe maternal morbidity | – | Other: Obstetric comorbidity indexPatients with either one of severe maternal morbidity (severe hemorrhage, hypertension/neurologic, renal, sepsis, pulmonary, cardiac, intensive care unit, and anesthesia complications) |
| Patients with postpartum hemorrhage without severe maternal morbidity | – | Other: Obstetric comorbidity indexPatients without the severe maternal morbidity conditions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- The patients underwent cesarean delivery with the diagnosis of postpartum hemorrhage (ICD-10 coding O72.1)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obstetric comorbidity indexObstetric comorbidity index score | Other | Patients with postpartum hemorrhage with severe maternal morbidity, Patients with postpartum hemorrhage without severe maternal morbidity |
Primary outcome
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)
7 secondary outcomes
Rate of blood transfusion
Time frame: in 72 hours after cesarean delivery
Quantity of postpartum hemorrhage
Time frame: in 24 hours after cesarean delivery
Cause of postpartum hemorrhage
Time frame: in 24 hours after cesarean delivery
Rate of ICU admission
Time frame: in 24 hours after cesarean delivery
Rate of Postoperative complications
Time frame: in 72 hours after cesarean delivery
Neonatal Apgar score
Time frame: at 1-minute and 5-minute after delivery
Rate of maternal mortality
Time frame: in 72 hours after cesarean delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patchareya Nivatpumin, M.D. principal investigator
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Postpartum Hemorrhage, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prediction of severe maternal morbidity using obstetric comorbidity index (time frame: in 72 hours after cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.