Postpartum Hemorrhage \(PPH\)
Conditions
Keywords
carbetocin, postpartum hemorrhage, oxytocin, emergency caesarean delivery
Brief summary
This study will be conducted to compare the effects of pabal and oxytocin administered to prevent postpartum hemorrhage in patients who were followed in the delivery room due to vaginal labor but underwent cesarean section due to emergency situations.
Detailed description
The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. The aim of this study is to compare the effectiveness of oxytocin or the long-acting oxytocin analog carbetocin (Pabal) administered to pregnant women to prevent postpartum hemorrhage after emergency cesarean delivery. The primary aim is to evaluate the amount of postpartum bleeding after the use of these two agents and to identify potential risk factors that may change the effectiveness of these drugs. The secondary aim is to observe the changes in intraoperative and postoperative hemodynamic parameters after the administration of these two drugs. According to NICE (National Institute Health and Care) and RCOG (Royal College of Obstetricians and Gynaecologists) guidelines, patients who are in the emergency caesarean category 1 (The life of the mother or baby is in danger. The caesarean should be performed as soon as possible, usually within 30 minutes after the decision is made) group will be included. Patients are routinely informed about the vaginal delivery process when they come into labor. It was planned to inform the women about the medications planned to be given to prevent postpartum hemorrhage in case of a possible emergency caesarean section and to obtain their written consent. The patient data was designed to be accessible from the hospital information system (Keydata Information Technology Technology Systems), and it was planned to re-check the patient files in order to increase the accuracy and reliability of the data. IBM SPSS Statistics 23.0 (IBM Corp., Armonk, NY, USA) will be used for statistical analysis.
Interventions
Carbetocin administered as a single dose immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
Oxytocin administered per institutional standard regimen immediately after delivery during emergency cesarean section for prophylaxis of postpartum hemorrhage
Sponsors
Study design
Eligibility
Inclusion criteria
* Term pregnancy (\>37 weeks gestation) * Singleton pregnancy * Vertex presentation * not having had a cesarean section before * emergency cesarean delivery (category 1) * low risk for postpartum hemorrhage * Vaginal labor has started (\> 4 cm cervical dilatation) or a decision has been made (rupture of membranes, Abnormal findings on NST or other signs of fetal compromise.)
Exclusion criteria
* Non-term pregnancy (\< 37 weeks gestation) * Non- vertex presentation * antenatal high risk pregnancy for postpartum hemorrhage (preeclampsia/eclampsia, previous uterine surgery, placental anomalies) * Twin pregnancy * Elective cesarean section planned
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative change in hemoglobin at 24 hours | Baseline (preoperative) and within 24 hours after emergency cesarean delivery | Change in hemoglobin (g/dL) from preoperative baseline to the lowest hemoglobin value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for additional uterotonic agents | Within 24 hours after cesarean delivery | Proportion of participants requiring any additional uterotonic agent(s) within 24 hours after cesarean delivery (after administration of the assigned study drug). |
| Postoperative change in hematocrit at 24 hours | Baseline (preoperative) and within 24 hours after emergency cesarean delivery | Change in hematocrit (%) from preoperative baseline to the lowest hematocrit value within 24 hours after emergency cesarean delivery, compared between the carbetocin and oxytocin groups. |
Countries
Turkey (Türkiye)
Contacts
Ankara Etlik City Hospital