Cesarean Section ComplicationsNCT04833556
Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery
An observational study of Cesarean Section Complications and Postpartum Hemorrhage, run by Mahidol University at 1 site in Thailand.
Trial summary
Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section Complications, Postpartum Hemorrhage, Anesthesia Complication
- How many people
- 649 participants
- Where
- 1 siteThailand
- Study dates
- 22 Apr 2021to 31 Dec 2024
- 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: Female patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Who may be able to join
- Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Who cannot join
- Cesarean delivery at less than 24 weeks of gestation
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery
Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
Read the detailed description
Postpartum hemorrhage (PPH) is the common cause of maternal death worldwide. It is interesting to note that PPH is the most common cause of death in developing country. Additionally, PPH is the common cause of maternal cardiac arrest. PPH defined as the amount of bleeding more than or equal to 500 ml after vaginal delivery and bleeding of more than or equal to 1,000 ml after cesarean delivery. The rate of PPH regardless any route of delivery was 2.9-3.2%. Rate of PPH in patients undergoing cesarean delivery was approximately 0.6% - 3.1%.
The difference in anesthetic techniques influence the rate of postpartum hemorrhage. Numerous studies showed the association between general anesthesia and postpartum hemorrhage in patient undergoing cesarean delivery. The outcome showed the odds of PPH in women who had cesarean delivery with general anesthesia were 8.15 times higher (95% CI 6.43-10.33) than for those who had CS with epidural anesthesia. Likewise, systematic review and meta-analysis revealed general anesthesia associated with higher amount of blood loss, but not the transfusion rate comparing with regional anesthesia. The decreasing of myometrial uterine tone from the usage of inhalational agents (halothane, enflurane, isofurane, sevoflurane, and desflurane) from general anesthesia explains this consequence.
Guidelines recommended the management of PPH after cesarean delivery were launched. World Health Organization (WHO) recommendation reported both surgical together with medical management (non-surgical) in patients with PPH, which published in the year 2012. The major role of anesthesiologists involving in treatment of PPH is medical treatment and blood and blood component administration. The novel medical treatment of PPH has been described in several literatures including the usage of tranexamic acid and fibrinogen concentrate. The World Maternal Antifibrinolytic trial (WOMAN trial) is the large-sample size randomized controlled trial publishing in the Lancet in the year 2017. WOMAN trial revealed the administration of tranexamic acid in patients with PPH after vaginal or cesarean delivery significantly reduced blood loss and decreased maternal mortality rate from bleeding. Likewise, Cochrane database systematic review concluded in the year 2018 that intravenous tranexamic acid reduced mortality rate due to bleeding in women with PPH, irrespective of mode of delivery. The WHO collaborator subsequently launched the update of recommendation including the administration of tranexamic acid 1 gram in PPH patients within 3 hours after birth.
Moreover, the rate of ICU admission after postpartum hemorrhage was studied revealing 15 of 21 patients (71.4%). Of which, 12 patients presented disseminated intravascular coagulation (DIC) and 2 cases death (9%). Critically-ill patients deriving from massive hemorrhage from PPH also transfusion-related acute lungs injury (TRALI), congestive heart failure, acute kidney injury and multiorgan failure.
In this study, we emphasize in patients underwent cesarean delivery with PPH (intraoperative estimated blood loss > 1,000 ml). The primary purpose is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
The detail of outcomes of PPH in cesarean delivered patients in Siriraj hospital is scared; and it has not yet been described in the literature. Therefore, the authors aim to collected the data and analyzed the outcomes associated with PPH, in order to report in the literatures as well as improving the anesthetic management of intraoperative PPH in our institute.
- Conditions
- Cesarean Section Complications, Postpartum Hemorrhage, Anesthesia Complication, Blood Transfusion Complication, Uterine Atony With Hemorrhage
- Keywords
- Cesarean section, Postpartum haemorrhage, Anesthesia complication, Blood transfusion, Intensive care unit admission
- Medical subject headings
- Postpartum Hemorrhage, Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum haemorrhage | Patients undergoing cesarean delivery with postpartum haemorrhage (blood loss more than or equal to 1,000 ml.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of blood transfusion
Rate of blood transfusion in patients with postpartum haemorrhage
Measured: In operating theatre to 24 hour postoperatively
Rate of ICU admission
Patients with postpartum haemorrhage required admission in the ICU
Measured: From 0-24 hours postoperatively
Secondary outcomes (10)
Amount of haemorrhage
Amount of blood loss after delivery
Measured: In operating theatre to 24 hour postoperatively
Rate of hysterectomy
Rate of hysterectomy after postpartum hemorrhage
Measured: In operating theatre to 24 hour postoperatively
Anesthetic technique
General anesthesia with endotracheal tube or regional anesthesia
Measured: In operating theatre to 24 hour postoperatively
Rate of blood component administration
Rate of patients receiving FFP, cryoprecipitate or platelets
Measured: In operating theatre to 24 hour postoperatively
Rate of Tranexamic acid administration
Rate of patients receiving Tranexamic acid
Measured: In operating theatre to 24 hour postoperatively
Causes of postpartum hemorrhage
Identify causes of postpartum hemorrhage
Measured: In operating theatre to 24 hour postoperatively
Factor associated ICU admission
Factor associated ICU admission after cesarean delivery with postpartum hemorrhage
Measured: In operating theatre to 24 hour postoperatively
Rate of complications after postpartum haemorrhage
Rate of complications after postpartum haemorrhage eg. prolong intubation, congestive heart failure, acute kidney injury, transfusion-related acute lungs injury (TRALI)
Measured: 0-30 days postoperatively
Maternal mortality rate
Report rate of maternal death
Measured: 0-30 days postoperatively
Neonatal outcomes
Neonatal Apgar score
Measured: At 1 and 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start22 Apr 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 649 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, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833556
- Sponsor's protocol ID
- 005/2564 (IRB4)
- Other IDs
- 161/2021
- Status last verified
- Dec 2025
- First submitted
- 1 Apr 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nivatpumin P, Nithi-Uthai J, Lertbunnaphong T, Sukcharoen N, Soponsiripakdee T, Yonphan P. Perioperative outcomes and causes of postpartum hemorrhage in patients undergoing cesarean delivery in Thailand: A comprehensive retrospective study. PLoS One. 2024 Apr 16;19(4):e0300620. doi: 10.1371/journal.pone.0300620. eCollection 2024.
PubMed 38626161Nivatpumin P, Nithiuthai J, Lertbunnaphong T. The impact of the WOMAN trial on local clinical practice in Thailand. J Anesth. 2025 Oct;39(5):828-830. doi: 10.1007/s00540-025-03518-6. Epub 2025 Jun 18.
PubMed 40533618Nithiuthai J, Lertbunnaphong T, Kongsayreepong S, Piriyapatsom A, Soponsiripakdee T, Nivatpumin P. Clinical Outcomes, Incidence, Associated Factors, and Prediction Model of Intensive Care Unit Admission in Women With Postpartum Hemorrhage Following Cesarean Delivery: A Secondary Analysis of a Tertiary-Care Cohort in Thailand. Obstet Gynecol Int. 2026 Aug 10;2026:9946379. doi: 10.1155/ogi/9946379. eCollection 2026.
PubMed 42577798
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Perioperative Outcomes of Postpartum Hemorrhage in Patients Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT04833556
- Acronym / sponsor ID
- 005/2564 (IRB4)
- Conditions
- Cesarean Section Complications, Postpartum Hemorrhage, Anesthesia Complication, Blood Transfusion Complication, Uterine Atony With Hemorrhage
- Keywords
- Cesarean section, Postpartum haemorrhage, Anesthesia complication, Blood transfusion, Intensive care unit admission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 22 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Apr 2021 (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.
Postpartum haemorrhage is the common cause of maternal death worldwide. The primary purpose of this study is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
Detailed description
Postpartum hemorrhage (PPH) is the common cause of maternal death worldwide. It is interesting to note that PPH is the most common cause of death in developing country. Additionally, PPH is the common cause of maternal cardiac arrest. PPH defined as the amount of bleeding more than or equal to 500 ml after vaginal delivery and bleeding of more than or equal to 1,000 ml after cesarean delivery. The rate of PPH regardless any route of delivery was 2.9-3.2%. Rate of PPH in patients undergoing cesarean delivery was approximately 0.6% - 3.1%.
The difference in anesthetic techniques influence the rate of postpartum hemorrhage. Numerous studies showed the association between general anesthesia and postpartum hemorrhage in patient undergoing cesarean delivery. The outcome showed the odds of PPH in women who had cesarean delivery with general anesthesia were 8.15 times higher (95% CI 6.43-10.33) than for those who had CS with epidural anesthesia. Likewise, systematic review and meta-analysis revealed general anesthesia associated with higher amount of blood loss, but not the transfusion rate comparing with regional anesthesia. The decreasing of myometrial uterine tone from the usage of inhalational agents (halothane, enflurane, isofurane, sevoflurane, and desflurane) from general anesthesia explains this consequence.
Guidelines recommended the management of PPH after cesarean delivery were launched. World Health Organization (WHO) recommendation reported both surgical together with medical management (non-surgical) in patients with PPH, which published in the year 2012. The major role of anesthesiologists involving in treatment of PPH is medical treatment and blood and blood component administration. The novel medical treatment of PPH has been described in several literatures including the usage of tranexamic acid and fibrinogen concentrate. The World Maternal Antifibrinolytic trial (WOMAN trial) is the large-sample size randomized controlled trial publishing in the Lancet in the year 2017. WOMAN trial revealed the administration of tranexamic acid in patients with PPH after vaginal or cesarean delivery significantly reduced blood loss and decreased maternal mortality rate from bleeding. Likewise, Cochrane database systematic review concluded in the year 2018 that intravenous tranexamic acid reduced mortality rate due to bleeding in women with PPH, irrespective of mode of delivery. The WHO collaborator subsequently launched the update of recommendation including the administration of tranexamic acid 1 gram in PPH patients within 3 hours after birth.
Moreover, the rate of ICU admission after postpartum hemorrhage was studied revealing 15 of 21 patients (71.4%). Of which, 12 patients presented disseminated intravascular coagulation (DIC) and 2 cases death (9%). Critically-ill patients deriving from massive hemorrhage from PPH also transfusion-related acute lungs injury (TRALI), congestive heart failure, acute kidney injury and multiorgan failure.
In this study, we emphasize in patients underwent cesarean delivery with PPH (intraoperative estimated blood loss > 1,000 ml). The primary purpose is to identify the maternal outcomes after PPH. The highlighted outcome is the anesthetic management including rate of blood transfusion and incidence of patient experiencing massive blood transfusion. The secondary purposes of this study are amount of blood loss, causes of PPH and other outcomes that related to PPH such as the rate of hysterectomy and postoperative outcome eg. congestive heart failure, acute kidney injury and TRALI etc. Additionally, incidence of PPH will be studied. Data collection will be made to identify the cause of PPH, anesthetic techniques that may related to the amount of hemorrhage, medical treatment for PPH and neonatal outcomes. We also aim to obtain the rate of ICU admission and revealed the factors involving the ICU admission in PPH patients underwent cesarean delivery.
The detail of outcomes of PPH in cesarean delivered patients in Siriraj hospital is scared; and it has not yet been described in the literature. Therefore, the authors aim to collected the data and analyzed the outcomes associated with PPH, in order to report in the literatures as well as improving the anesthetic management of intraoperative PPH in our institute.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum haemorrhage | – | –Patients undergoing cesarean delivery with postpartum haemorrhage (blood loss more than or equal to 1,000 ml.) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Key inclusion criteria (1 listed)
- Patients underwent cesarean delivery with estimated blood loss equal or more than 1,000 ml
Key exclusion criteria (2 listed)
- Cesarean delivery at less than 24 weeks of gestation
- Patient chart that not contained primary outcome data eg. absent of the anesthetic record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of blood transfusion
Time frame: In operating theatre to 24 hour postoperatively
Rate of blood transfusion in patients with postpartum haemorrhage
Rate of ICU admission
Time frame: From 0-24 hours postoperatively
Patients with postpartum haemorrhage required admission in the ICU
10 secondary outcomes
Amount of haemorrhage
Time frame: In operating theatre to 24 hour postoperatively
Rate of hysterectomy
Time frame: In operating theatre to 24 hour postoperatively
Anesthetic technique
Time frame: In operating theatre to 24 hour postoperatively
Rate of blood component administration
Time frame: In operating theatre to 24 hour postoperatively
Rate of Tranexamic acid administration
Time frame: In operating theatre to 24 hour postoperatively
Causes of postpartum hemorrhage
Time frame: In operating theatre to 24 hour postoperatively
Factor associated ICU admission
Time frame: In operating theatre to 24 hour postoperatively
Rate of complications after postpartum haemorrhage
Time frame: 0-30 days postoperatively
Maternal mortality rate
Time frame: 0-30 days postoperatively
Neonatal outcomes
Time frame: At 1 and 5 minutes after 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 22 Dec 2025.
- Results publication: PubMed 38626161Nivatpumin P, Nithi-Uthai J, Lertbunnaphong T, Sukcharoen N, Soponsiripakdee T, Yonphan P. Perioperative outcomes and causes of postpartum hemorrhage in patients undergoing cesarean delivery in Thailand: A comprehensive retrospective study. PLoS One. 2024 Apr 16;19(4):e0300620. doi: 10.1371/journal.pone.0300620. eCollection 2024.
- Results publication: PubMed 40533618Nivatpumin P, Nithiuthai J, Lertbunnaphong T. The impact of the WOMAN trial on local clinical practice in Thailand. J Anesth. 2025 Oct;39(5):828-830. doi: 10.1007/s00540-025-03518-6. Epub 2025 Jun 18.
- Derived from this study: PubMed 42577798Nithiuthai J, Lertbunnaphong T, Kongsayreepong S, Piriyapatsom A, Soponsiripakdee T, Nivatpumin P. Clinical Outcomes, Incidence, Associated Factors, and Prediction Model of Intensive Care Unit Admission in Women With Postpartum Hemorrhage Following Cesarean Delivery: A Secondary Analysis of a Tertiary-Care Cohort in Thailand. Obstet Gynecol Int. 2026 Aug 10;2026:9946379. doi: 10.1155/ogi/9946379. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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
Mahidol University
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 2 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 22 Dec 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?
Rate of blood transfusion (time frame: In operating theatre to 24 hour postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833556, which also lists 3 linked publications.
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 22 Dec 2025.