Postoperative BleedingNCT06005831
Uterine Fundus Pressure in Reduction of Cesarean Bleeding
A study testing sandbag in people with Postoperative Bleeding, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Uterine compression methods reduce the amount of postpartum bleeding. In our study, we investigated the effect of fundal pressure, which will be created by a sandbag placed on the abdomen, on reducing post-cesarean bleeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Bleeding
- What is being tested?
- sandbag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
Who cannot join
- Invasion anomaly,
- Diagnosed with preeclampsia,
- Placenta previa cases,
- Hypertensive pregnant women receiving antihypertensive therapy,
- Diabetic pregnant women,
- Multiple pregnancies,
Show all 16Show fewer
- Major hepatic, cardiac, renal, respiratory disorders
- Deep vein thrombosis during pregnancy,
- Receiving anticoagulant therapy
- Patients who developed atony and uterine rupture in the operating room,
- Suspected placental invasion
- Uterine balloon tamponade
- Arterial embolization
- Uterine and hypogastric artery ligation,
- Uterine compression sutures
- Intraoperative blood loss was estimated to be over 1000 mL during CS and who received intraoperative blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Application of Uterine Fundus Pressure With a Sandbag Effective in Reduction of Cesarean Bleeding? A Prospective Case Control Stud
Uterine compression methods reduce the amount of postpartum bleeding. In our study, we investigated the effect of fundal pressure, which will be created by a sandbag placed on the abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty of Medicine between January 2021 and December 2021 were included in this prospective, randomized, single-center study.
Read the detailed description
A total of 482 patients who gave birth by CS in the Obstetrics Clinic of Fırat University Faculty of Medicine between 1 January 2021 and 31 December 2021 were included in the study. Approval was obtained from the Ethics Committee of Fırat University for this prospective randomized single-center study (Ethics committee date = 15.10.2020; decision no = 2020/14-02). The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized. Each patient was followed up in our obstetrics clinic until discharge from the hospital after surgery and the data were analyzed. The same techniques were used in all surgical procedures in order not to create differences in terms of surgical techniques and operation times that may affect intraoperative bleeding. However, to minimize inter-operator variations, surgical procedures were performed by operators with sufficient surgical experience.
The standard sandbag used in our clinic was 20 × 20 × 3 cm3 in dimensions and 3 kg in weight. Sandbags of the same standard were used for all patients. After the patient was taken to the patient's bed, the uterine fundus was palpated, and then the sandbag was placed on the abdomen, just above the fundus, in such a way as to apply pressure to the fundus. The sandbag was kept on the abdomen for approximately 6 hours. During this period, the patient was followed up frequently and care was taken not to change the position of the sandbag. Sandbags were removed just before our patients were mobilized (approximately 6 hours). The sandbag was placed on the same spot in each patient by the obstetric assistants in our author team. In addition, preoperative and postoperative follow-ups and data acquisition and storage were performed by the same team 2.1 Study Design
It is a prospective, randomized, controlled single-center study.
2.2 Inclusion Criteria
All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
2.3 Exclusion Criteria
- Invasion anomaly,
- Diagnosed with preeclampsia,
- Placenta previa cases,
- Hypertensive pregnant women receiving antihypertensive therapy,
- Diabetic pregnant women,
- Multiple pregnancies,
- Major hepatic, cardiac, renal, respiratory disorders
- Deep vein thrombosis during pregnancy,
- Receiving anticoagulant therapy
- Patients who developed atony and uterine rupture in the operating room,
- Suspected placental invasion
- Uterine balloon tamponade
- Arterial embolization
- Uterine and hypogastric artery ligation,
- Uterine compression sutures
- Intraoperative blood loss was estimated to be over 1000 mL during CS and who received intraoperative blood transfusion
2.4 Patient Selection
For randomization, patients were fully informed about the study while preparing for CS. Sandbags were placed in all cases included in the study after meeting the study criteria for between 1 January 2021 and 30 June 2021. Sandbags were not placed in the cases who met the study criteria and were included in the study between 1 July 2021 and 31 December 2021.2.5 Sampling Technique
Qualified participants who gave informed consent to participate in the study were randomly assigned to groups. Visual analog scale (VAS) was used for postoperative pain scoring at the 8th and 24th postoperative hours. The patient included in the study was randomized into control group or weighted group by another assistant doctor who did not participate in the CS and did not know about the patient.
2.6 Postoperative Monitoring
All cases were given 10 IU of oxytocin IV during CS, after prophylactic antibiotic therapy and placenta separation. After CS, 40 IU of oxytocin (Synpitan® forte ampule 5 IU, Deva, Istanbul, Turkey) was administered intravenously in 500 mL saline and at an infusion rate of 125 mL/hour. At the same time, 0.2-0.4 µg methylergonovine maleate (Methergine® ampule 0.2 µmg, Sandoz, Istanbul, Turkey) was given intravenously/intramuscularly in cases without hypertension. All patients were treated according to the postoperative protocol for CS performed in our obstetrics clinic. At the 8th and 24th hours postoperatively, the researchers determined the patient's hemoglobin (Hb) and hematocrit (Hct) concentrations and the amount of vaginal bleeding. In addition, the time of milk coming from the breast and VAS were performed. Patients with a postoperative Hb value of <7 g/dL received blood transfusion. Considering the risks of blood transfusion, blood transfusion is primarily planned in symptomatic patients with an Hct value of <20%, as stated in the bulletin of The American College of Obstetricians and Gynecologists (ACOG), but if the Hb is below 7 g/dL, it is hemodynamically stable and in asymptomatic patients, the treatment is individualized and alternative to transfusion, oral anti anemic or intravenous iron therapy is applied.
2.7 Determination of the Amount of Postoperative Blood Loss
Postoperative blood loss was determined by monitoring the pad and measuring the hemoglobin values at the 8th and 24th hours in all cases. Standard pads measuring 10 × 10 cm2 was used. The main advantage of this method of visually assessing blood loss is that it is a real-time assessment and allows the person accompanying the delivery to correlate it with the patient's clinical findings. However, significant differences between clinical evaluation and actual measurements have been clearly demonstrated in many studies has been reported that gravimetric blood loss estimation methods or serum lactate measurements can provide a more objective assessment of bleeding. It has been reported that visual and gravimetric blood loss estimation measurements show a high degree of bias and therefore their routine use cannot be recommended. On the other hand, it has been stated that colorimetric technology offers real-time measurement and has a high degree of correlation. For this reason, we used the preoperatively and postoperatively at the 8th and 24th hours hemoglobin values. Postpartum anemia was defined as hemoglobin concentration (Hb) <10 g/dL in the postpartum period.
- Conditions
- Postoperative Bleeding
- Being tested
- sandbag
- Keywords
- cesarean section, fundal pressure, postoperative bleeding, sandbag
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sandbagOther
The standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight
| Study group | Role | What they receive |
|---|---|---|
| Sandbag | Other | Sandbag Receives: Other: sandbag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BleedingStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It is a prospective, randomized, controlled single-center study.
- Masking
- None (open label)
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa YILMAZ, Firat University
- Investigators
- Sehmus Pala, Study chair, University of Firat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005831
- Sponsor's protocol ID
- 2020/14-02
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Application of Uterine Fundus Pressure With a Sandbag Effective in Reduction of Cesarean Bleeding? A Prospective Case Control Stud
- ClinicalTrials.gov ID
- NCT06005831
- Acronym / sponsor ID
- 2020/14-02
- Conditions
- Postoperative Bleeding
- Keywords
- cesarean section, fundal pressure, postoperative bleeding, sandbag
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Aug 2023 (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.
Uterine compression methods reduce the amount of postpartum bleeding. In our study, we investigated the effect of fundal pressure, which will be created by a sandbag placed on the abdomen, on reducing post-cesarean bleeding. Material and Methods: A total of 482 patients who delivered by cesarean section (CS) in the Obstetrics Clinic of Fırat University Faculty of Medicine between January 2021 and December 2021 were included in this prospective, randomized, single-center study.
Detailed description
A total of 482 patients who gave birth by CS in the Obstetrics Clinic of Fırat University Faculty of Medicine between 1 January 2021 and 31 December 2021 were included in the study. Approval was obtained from the Ethics Committee of Fırat University for this prospective randomized single-center study (Ethics committee date = 15.10.2020; decision no = 2020/14-02). The 482 patients who had CS were divided into two groups, control group (n = 246), weighted group (n = 236) was randomized. Each patient was followed up in our obstetrics clinic until discharge from the hospital after surgery and the data were analyzed. The same techniques were used in all surgical procedures in order not to create differences in terms of surgical techniques and operation times that may affect intraoperative bleeding. However, to minimize inter-operator variations, surgical procedures were performed by operators with sufficient surgical experience.
The standard sandbag used in our clinic was 20 × 20 × 3 cm3 in dimensions and 3 kg in weight. Sandbags of the same standard were used for all patients. After the patient was taken to the patient's bed, the uterine fundus was palpated, and then the sandbag was placed on the abdomen, just above the fundus, in such a way as to apply pressure to the fundus. The sandbag was kept on the abdomen for approximately 6 hours. During this period, the patient was followed up frequently and care was taken not to change the position of the sandbag. Sandbags were removed just before our patients were mobilized (approximately 6 hours). The sandbag was placed on the same spot in each patient by the obstetric assistants in our author team. In addition, preoperative and postoperative follow-ups and data acquisition and storage were performed by the same team 2.1 Study Design
It is a prospective, randomized, controlled single-center study.
2.2 Inclusion Criteria
All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
2.3 Exclusion Criteria
- Invasion anomaly,
- Diagnosed with preeclampsia,
- Placenta previa cases,
- Hypertensive pregnant women receiving antihypertensive therapy,
- Diabetic pregnant women,
- Multiple pregnancies,
- Major hepatic, cardiac, renal, respiratory disorders
- Deep vein thrombosis during pregnancy,
- Receiving anticoagulant therapy
- Patients who developed atony and uterine rupture in the operating room,
- Suspected placental invasion
- Uterine balloon tamponade
- Arterial embolization
- Uterine and hypogastric artery ligation,
- Uterine compression sutures
- Intraoperative blood loss was estimated to be over 1000 mL during CS and who received intraoperative blood transfusion
2.4 Patient Selection
For randomization, patients were fully informed about the study while preparing for CS. Sandbags were placed in all cases included in the study after meeting the study criteria for between 1 January 2021 and 30 June 2021. Sandbags were not placed in the cases who met the study criteria and were included in the study between 1 July 2021 and 31 December 2021.2.5 Sampling Technique
Qualified participants who gave informed consent to participate in the study were randomly assigned to groups. Visual analog scale (VAS) was used for postoperative pain scoring at the 8th and 24th postoperative hours. The patient included in the study was randomized into control group or weighted group by another assistant doctor who did not participate in the CS and did not know about the patient.
2.6 Postoperative Monitoring
All cases were given 10 IU of oxytocin IV during CS, after prophylactic antibiotic therapy and placenta separation. After CS, 40 IU of oxytocin (Synpitan® forte ampule 5 IU, Deva, Istanbul, Turkey) was administered intravenously in 500 mL saline and at an infusion rate of 125 mL/hour. At the same time, 0.2-0.4 µg methylergonovine maleate (Methergine® ampule 0.2 µmg, Sandoz, Istanbul, Turkey) was given intravenously/intramuscularly in cases without hypertension. All patients were treated according to the postoperative protocol for CS performed in our obstetrics clinic. At the 8th and 24th hours postoperatively, the researchers determined the patient's hemoglobin (Hb) and hematocrit (Hct) concentrations and the amount of vaginal bleeding. In addition, the time of milk coming from the breast and VAS were performed. Patients with a postoperative Hb value of <7 g/dL received blood transfusion. Considering the risks of blood transfusion, blood transfusion is primarily planned in symptomatic patients with an Hct value of <20%, as stated in the bulletin of The American College of Obstetricians and Gynecologists (ACOG), but if the Hb is below 7 g/dL, it is hemodynamically stable and in asymptomatic patients, the treatment is individualized and alternative to transfusion, oral anti anemic or intravenous iron therapy is applied.
2.7 Determination of the Amount of Postoperative Blood Loss
Postoperative blood loss was determined by monitoring the pad and measuring the hemoglobin values at the 8th and 24th hours in all cases. Standard pads measuring 10 × 10 cm2 was used. The main advantage of this method of visually assessing blood loss is that it is a real-time assessment and allows the person accompanying the delivery to correlate it with the patient's clinical findings. However, significant differences between clinical evaluation and actual measurements have been clearly demonstrated in many studies has been reported that gravimetric blood loss estimation methods or serum lactate measurements can provide a more objective assessment of bleeding. It has been reported that visual and gravimetric blood loss estimation measurements show a high degree of bias and therefore their routine use cannot be recommended. On the other hand, it has been stated that colorimetric technology offers real-time measurement and has a high degree of correlation. For this reason, we used the preoperatively and postoperatively at the 8th and 24th hours hemoglobin values. Postpartum anemia was defined as hemoglobin concentration (Hb) <10 g/dL in the postpartum period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It is a prospective, randomized, controlled single-center study.
| Arm | Type | Receives |
|---|---|---|
| Sandbag | Other | Other: sandbagSandbag |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All cases with CS who had a live pregnancy after 24 weeks of gestation were included in the study.
Key exclusion criteria (16 listed)
- Invasion anomaly,
- Diagnosed with preeclampsia,
- Placenta previa cases,
- Hypertensive pregnant women receiving antihypertensive therapy,
- Diabetic pregnant women,
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 |
|---|---|---|
| sandbagThe standard sandbag used in our clinic, 20 × 20 × 3 cm3 in dimensions and 3 kg in weight | Other | Sandbag |
Primary outcome
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
Time frame: 24 hours
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding.
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 23 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Sehmus Pala study chair
University of Firat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sandbag in people with Postoperative Bleeding, run by Firat University at 1 site in Turkey (Türkiye).
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 16 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 23 Aug 2023. 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 Turkey (Türkiye). 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?
Whether the fundal pressure created by the sandbag placed on the abdomen has an effect on reducing post-cesarean bleeding. (time frame: 24 hours). 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 23 Aug 2023.