Postpartum HemorrhageRUCS-PPHNCT07115355
Evaluating the Safety and Efficacy of RUCS in PPH
An observational study of Postpartum Hemorrhage, run by Havva Betül Bacak at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to evaluate the efficacy and safety of Removable Uterine Compression Sutures (RUCS) in the surgical management of postpartum hemorrhage (PPH). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Removable Uterine Compression Suture (RUCS)
- Type of treatment
- Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jun 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women aged 18-45 who developed postpartum hemorrhage following delivery and were treated with Removable Uterine Compression Sutures (RUCS) at Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. Only patients with complete and accessible medical records were included in this retrospective case series.
Who may be able to join
- Female patients aged 18 to 45 years Diagnosed with postpartum hemorrhage (PPH) following delivery Treated with Removable Uterine Compression Suture (RUCS) Delivery and treatment performed at Gaziosmanpaşa Training and Research Hospital RUCS performed between January 2020 and November 2024 Complete and accessible medical records
Who cannot join
- Incomplete or missing medical records Use of alternative surgical techniques other than RUCS Patients outside the age range of 18-45 Cases not treated at Gaziosmanpaşa Training and Research Hospital Postpartum hemorrhage not managed with RUCS
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul
About this study
Official title: Removable Uterine Compression Sutures (RUCS): Evaluation of Efficacy and Safety in Postpartum Hemorrhage
This retrospective observational study aims to evaluate the efficacy and safety of Removable Uterine Compression Sutures (RUCS) in the surgical management of postpartum hemorrhage (PPH). Eleven patients who developed PPH and underwent RUCS between January 2020 and November 2024 at Gaziosmanpaşa Training and Research Hospital were included. The primary outcomes assessed were hemorrhage control and procedure-related complications. Data were collected from patient records and analyzed descriptively.
Read the detailed description
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide. When medical management is insufficient, surgical interventions become necessary. Removable Uterine Compression Sutures (RUCS) have been developed as a uterus-sparing surgical technique that may offer effective hemostasis with a potentially lower risk of complications such as intrauterine synechiae, when compared to traditional permanent suture methods.
This single-center retrospective observational case series evaluated 11 patients who experienced PPH and were treated with RUCS at the Obstetrics and Gynecology Clinic of Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. Patients were included if they had complete medical records and underwent RUCS after delivery. Cases involving other surgical techniques or missing data were excluded.
Clinical data were extracted from hospital archives and electronic medical systems. All data were anonymized prior to analysis. Descriptive statistics were used, including means and standard deviations for continuous variables and frequencies for categorical variables.
The study aimed to assess both the efficacy of RUCS in controlling bleeding and its safety by monitoring postoperative complications such as intrauterine synechiae and uterine necrosis. Initial findings indicate 100% success in hemostasis with no observed major complications, suggesting that RUCS may be a safe and effective option in selected cases of postpartum hemorrhage.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Removable Uterine Compression Suture (RUCS)
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable Uterine Compression Suture (RUCS)Procedure or surgery
Removable Uterine Compression Suture (RUCS) is a uterus-preserving surgical technique used to control postpartum hemorrhage (PPH) when medical management fails. The suture is placed in a way that allows for its removal after hemostasis is achieved, potentially reducing the risk of complications such as intrauterine synechiae. In this study, RUCS was applied to 11 patients following delivery-related hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| RUCS Group | This group includes women aged 18-45 who experienced postpartum hemorrhage and were treated with Removable Uterine Compression Sutures (RUCS) at Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. All patients had complete medical records and underwent retrospective data analysis. Receives: Procedure: Removable Uterine Compression Suture (RUCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis success rate following RUCS application
Successful control of postpartum bleeding without the need for additional surgical intervention, blood transfusion exceeding 4 units, or hysterectomy.
Measured: Within the first 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2020
- Primary completion30 Nov 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havva Betül Bacak
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Havva Betül Bacak, Gaziosmanpasa Research and Education Hospital
- Investigators
- fatih irice, md, Study chair, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115355
- Sponsor's protocol ID
- GopRucs
- Acronym
- RUCS-PPH
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removable Uterine Compression Sutures (RUCS): Evaluation of Efficacy and Safety in Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT07115355
- Acronym / sponsor ID
- RUCS-PPH / GopRucs
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Havva Betül BacakOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 11 Aug 2025 (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.
This retrospective observational study aims to evaluate the efficacy and safety of Removable Uterine Compression Sutures (RUCS) in the surgical management of postpartum hemorrhage (PPH). Eleven patients who developed PPH and underwent RUCS between January 2020 and November 2024 at Gaziosmanpaşa Training and Research Hospital were included. The primary outcomes assessed were hemorrhage control and procedure-related complications. Data were collected from patient records and analyzed descriptively.
Detailed description
Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide. When medical management is insufficient, surgical interventions become necessary. Removable Uterine Compression Sutures (RUCS) have been developed as a uterus-sparing surgical technique that may offer effective hemostasis with a potentially lower risk of complications such as intrauterine synechiae, when compared to traditional permanent suture methods.
This single-center retrospective observational case series evaluated 11 patients who experienced PPH and were treated with RUCS at the Obstetrics and Gynecology Clinic of Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. Patients were included if they had complete medical records and underwent RUCS after delivery. Cases involving other surgical techniques or missing data were excluded.
Clinical data were extracted from hospital archives and electronic medical systems. All data were anonymized prior to analysis. Descriptive statistics were used, including means and standard deviations for continuous variables and frequencies for categorical variables.
The study aimed to assess both the efficacy of RUCS in controlling bleeding and its safety by monitoring postoperative complications such as intrauterine synechiae and uterine necrosis. Initial findings indicate 100% success in hemostasis with no observed major complications, suggesting that RUCS may be a safe and effective option in selected cases of postpartum hemorrhage.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RUCS Group | – | Procedure: Removable Uterine Compression Suture (RUCS)This group includes women aged 18-45 who experienced postpartum hemorrhage and were treated with Removable Uterine Compression Sutures (RUCS) at Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. All patients had complete medical records and underwent retrospective data analysis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women aged 18-45 who developed postpartum hemorrhage following delivery and were treated with Removable Uterine Compression Sutures (RUCS) at Gaziosmanpaşa Training and Research Hospital between January 2020 and November 2024. Only patients with complete and accessible medical records were included in this retrospective case series.
Key inclusion criteria (1 listed)
- Female patients aged 18 to 45 years Diagnosed with postpartum hemorrhage (PPH) following delivery Treated with Removable Uterine Compression Suture (RUCS) Delivery and treatment performed at Gaziosmanpaşa Training and Research Hospital RUCS performed between January 2020 and November 2024 Complete and accessible medical records
Key exclusion criteria (1 listed)
- Incomplete or missing medical records Use of alternative surgical techniques other than RUCS Patients outside the age range of 18-45 Cases not treated at Gaziosmanpaşa Training and Research Hospital Postpartum hemorrhage not managed with RUCS
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 |
|---|---|---|
| Removable Uterine Compression Suture (RUCS)Removable Uterine Compression Suture (RUCS) is a uterus-preserving surgical technique used to control postpartum hemorrhage (PPH) when medical management fails. The suture is placed in a way that allows for its removal after hemostasis is achieved, potentially reducing the risk of complications such as intrauterine synechiae. In this study, RUCS was applied to 11 patients following delivery-related hemorrhage. | Procedure or surgery | RUCS Group |
Primary outcome
Hemostasis success rate following RUCS application
Time frame: Within the first 24 hours post-procedure
Successful control of postpartum bleeding without the need for additional surgical intervention, blood transfusion exceeding 4 units, or hysterectomy.
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 11 Aug 2025.
- Individual participant dataSharing planned: No
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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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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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.
fatih irice, md study chair
University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
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 Postpartum Hemorrhage, run by Havva Betül Bacak 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 1 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 11 Aug 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 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?
Hemostasis success rate following RUCS application (time frame: Within the first 24 hours post-procedure). 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 11 Aug 2025.