Postpartum HemorrhageNCT05948436
The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section
A study testing Clamping the uterine artery bilaterally during Cesarean section in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage, Cesarean Section Complications
- What is being tested?
- Clamping the uterine artery bilaterally during Cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2023to 2 Oct 2023
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women gave birth >37 GW
- singleton pregnancy
- with normal fetal development
- Not emergency C-section
Who cannot join
- C/sections with indications of plasenta prevue or placenta acrreta spectrum
- with amniotic fluid abnormalities
- multiple pregnancies
- threatened preterm labor
- who have preeclampsia or other type of obstetrical complications
- maternal obesity (BMI>30kg/m2)
- maternal cardiovascular disease, hypertension, coagulation defects, women who use anticoagulants
- patients who underwent Cesarean section during active labor
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
Official title: The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial
The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. In this study, we aim to decrease the amount of postpartum hemorrhage by clamping the uterine artery after the delivery of the baby during Cesarean delivery.
Read the detailed description
Obstetrical hemorrhage, is the most common cause of maternal mortality and morbidity that could be prevented. It can appear at early and late stage of delivery and after delivery. It Is defined as loss of more than 500 mL of blood in vaginal deliveries, whereas more than 1L of blood during C-section. The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. The incidence of postpartum anemia in Europe is 50% while in developing countries like Turkey it rises up to 50-80%. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. To preserve the hemoglobin concentrations and hemostasis and to optimize the patient's results, evidence-based methods should be performed. Given these circumstances, interventions using pharmacological, mechanical and surgical methods are necessary to minimize the blood loss. Uteroronics are the first line treatment options followed by fundal massage, controlled traction of cord and delivery of placenta, bimanual compression, intrauterine hydrostatic balloon. After these interventions, surgical interventions such as compression sutures, bilateral uterine artery ligation, hysterectomy and pelvic tamponade could be performed. In this study, we aim to decrease the amount of preoperative part of postpartum hemorrhage by clamping the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta during Cesarean delivery.
- Being tested
- Clamping the uterine artery bilaterally during Cesarean section
- Keywords
- postpartum hemorrhage, cesarean section
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clamping the uterine artery bilaterally during Cesarean sectionProcedure or surgery
We clamped the uterine artery by Darmklemmen clamp, which grasps the tissue delicately without damage, after the delivery of the baby before the delivery of placenta. The clamp is released after the suturing of Munro-Kerr incision is finished, before bleeding control. The duration of clamping time is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Clamp | Experimental | In these patients, we clamped the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta. We released the clamp after the suturing of the uterus is finished. Receives: Procedure: Clamping the uterine artery bilaterally during Cesarean section |
| Control | No intervention | Routine Cesarean section is done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of blood loss
by measuring the suction canister
Measured: during C-section
The rate of blood loss
by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare
Measured: during C-section
The rate of blood loss
by comparing the preoperative and postoperative hemoglobin and hematocrit values
Measured: 24 hours
Secondary outcomes (3)
Operation time
minutes
Measured: during C-section
Postoperative complications
need for relaparatomy, vascular or organ injury
Measured: postoperative 48 hours
neonatal outcomes
APGAR scores
Measured: during C-section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start10 Jul 2023
- Primary completion30 Sep 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek B. Ozcivit Erkan, MD, Istanbul University - Cerrahpasa
- Investigators
- Ismail Cepni, Prof, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948436
- Sponsor's protocol ID
- 37612
- Status last verified
- Jan 2024
- First submitted
- 10 Jul 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, will ve shared after de identification. The data will be available immediately following publication. No end date. The data will be shared to anyone who wishes to access the data. It could be used for any purpose. Data will be available to anyone who proposes. Proposals should be directed to ipekbetulozcivit@gmail.com, and the link will be provided.
Publications
Cepni I, Hamzaoglu Canbolat K, Ozcivit Erkan IB, Sayili U, Yuksel Ozgor B, Ozak E, Mahmudova A, Madazli R, Ocal KP. The Cepni modification: using bilateral vascular clamps during caesarean section for intrapartum hemorrhage, a randomized controlled trial. J Turk Ger Gynecol Assoc. 2025 Jun 10;26(2):73-81. doi: 10.4274/jtgga.galenos.2025.2024-10-4.
PubMed 40495474
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mechanical Methods on the Postpartum Haemorrhage Prophylaxis During Caesarean Section; A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT05948436
- Acronym / sponsor ID
- 37612
- Keywords
- postpartum hemorrhage, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 17 Jul 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.
The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. In this study, we aim to decrease the amount of postpartum hemorrhage by clamping the uterine artery after the delivery of the baby during Cesarean delivery.
Detailed description
Obstetrical hemorrhage, is the most common cause of maternal mortality and morbidity that could be prevented. It can appear at early and late stage of delivery and after delivery. It Is defined as loss of more than 500 mL of blood in vaginal deliveries, whereas more than 1L of blood during C-section. The rate of heavy blood loss is higher in Cesarean delivery compared to vaginal deliveries. The incidence of postpartum anemia in Europe is 50% while in developing countries like Turkey it rises up to 50-80%. Since postpartum hemorrhage is a life threatening situation to decrease the maternal mortality and morbidity rates, precautions should be taken. To preserve the hemoglobin concentrations and hemostasis and to optimize the patient's results, evidence-based methods should be performed. Given these circumstances, interventions using pharmacological, mechanical and surgical methods are necessary to minimize the blood loss. Uteroronics are the first line treatment options followed by fundal massage, controlled traction of cord and delivery of placenta, bimanual compression, intrauterine hydrostatic balloon. After these interventions, surgical interventions such as compression sutures, bilateral uterine artery ligation, hysterectomy and pelvic tamponade could be performed. In this study, we aim to decrease the amount of preoperative part of postpartum hemorrhage by clamping the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta during Cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clamp | Experimental | Procedure: Clamping the uterine artery bilaterally during Cesarean sectionIn these patients, we clamped the uterine artery by Darmklemmen clamp after the delivery of the baby before the delivery of placenta. We released the clamp after the suturing of the uterus is finished. |
| Control | No intervention | –Routine Cesarean section is done. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women gave birth >37 GW
- singleton pregnancy
- with normal fetal development
- Not emergency C-section
Key exclusion criteria (8 listed)
- C/sections with indications of plasenta prevue or placenta acrreta spectrum
- with amniotic fluid abnormalities
- multiple pregnancies
- threatened preterm labor
- who have preeclampsia or other type of obstetrical complications
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 |
|---|---|---|
| Clamping the uterine artery bilaterally during Cesarean sectionWe clamped the uterine artery by Darmklemmen clamp, which grasps the tissue delicately without damage, after the delivery of the baby before the delivery of placenta. The clamp is released after the suturing of Munro-Kerr incision is finished, before bleeding control. The duration of clamping time is recorded. | Procedure or surgery | Clamp |
Primary outcome
The rate of blood loss
Time frame: during C-section
by measuring the suction canister
The rate of blood loss
Time frame: during C-section
by weighting the gauze+abdominal compress+under pads used during C-section after subtracting the tare
The rate of blood loss
Time frame: 24 hours
by comparing the preoperative and postoperative hemoglobin and hematocrit values
3 secondary outcomes
Operation time
Time frame: during C-section
Postoperative complications
Time frame: postoperative 48 hours
neonatal outcomes
Time frame: during C-section
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 12 Jan 2024.
- Derived from this study: PubMed 40495474Cepni I, Hamzaoglu Canbolat K, Ozcivit Erkan IB, Sayili U, Yuksel Ozgor B, Ozak E, Mahmudova A, Madazli R, Ocal KP. The Cepni modification: using bilateral vascular clamps during caesarean section for intrapartum hemorrhage, a randomized controlled trial. J Turk Ger Gynecol Assoc. 2025 Jun 10;26(2):73-81. doi: 10.4274/jtgga.galenos.2025.2024-10-4.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, will ve shared after de identification. The data will be available immediately following publication. No end date. The data will be shared to anyone who wishes to access the data. It could be used for any purpose. Data will be available to anyone who proposes. Proposals should be directed to ipekbetulozcivit@gmail.com, and the link will be provided.
Related trials for Postpartum Hemorrhage
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Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
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Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
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Prevention of Postpartum Hemorrhage With Tranexamic Acid
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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.
Ismail Cepni, Prof study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clamping the uterine artery bilaterally during Cesarean section in people with Postpartum Hemorrhage and Cesarean Section Complications, run by Istanbul University - Cerrahpasa 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 4 inclusion and 8 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 12 Jan 2024. 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?
The rate of blood loss (time frame: during C-section). The study lists 3 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 NCT05948436, which also lists 1 linked publication.
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 12 Jan 2024.