Clinical trial NCT06431204: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section Complications
Postpartum Hemorrhage
Morbidity;Perinatal
Keywords: cesarean section
postpartum hemorrhage
maternal morbidity
obstetrics comorbidity index
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 576
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The prediction of severe maternal morbidity using obstetric comorbidity index
timeFrame: in 72 hours after cesarean delivery
Secondary outcomes:
measure: Rate of blood transfusion
timeFrame: in 72 hours after cesarean delivery
measure: Quantity of postpartum hemorrhage
timeFrame: in 24 hours after cesarean delivery
measure: Cause of postpartum hemorrhage
timeFrame: in 24 hours after cesarean delivery
measure: Rate of ICU admission
timeFrame: in 24 hours after cesarean delivery
measure: Rate of Postoperative complications
timeFrame: in 72 hours after cesarean delivery
measure: Neonatal Apgar score
timeFrame: at 1-minute and 5-minute after delivery
measure: Rate of maternal mortality
timeFrame: in 72 hours after cesarean delivery
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok THAILAND
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: