- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07115355
- Original Trial
Evaluating the Safety and Efficacy of RUCS in PPH (RUCS-PPH)
Removable Uterine Compression Sutures (RUCS): Evaluation of Efficacy and Safety in Postpartum Hemorrhage
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Gaziosmanpasa Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within the first 24 hours post-procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: fatih irice, md, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GopRucs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postpartum Hemorrhage
-
Dangana Zakari AdekaWest African College of Surgeons (WACS)CompletedPostpartum Hemorrhage (PPH) | Postpartum Hemorrhage Third Stage of Labour Retained PlacentaNigeria
-
ResQ Medical LtdRecruitingPPH | Postpartum Hemorrhage \(PPH\) | Postpartum Hemorrhage \(Primary\)Kenya
-
University Hospital, Clermont-FerrandUnknownPostpartum Depression | Postpartum Hemorrhage | Postpartum Women | Postpartum Stress | Postpartum AnxietyFrance
-
Cairo UniversityUnknownHemorrhage, PostpartumEgypt
-
Columbia UniversityCompletedHemorrhage, PostpartumUnited States
-
Samuel Lunenfeld Research Institute, Mount Sinai...RecruitingPostpartum Hemorrhage (Primary)Canada
-
Megan LordThermaSENSE CorpCompletedHemorrhage | Vasoconstriction | Hemorrhage, PostpartumUnited States
-
Ain Shams Maternity HospitalUnknownHemorrhage PostpartumEgypt
-
Chelsea and Westminster NHS Foundation TrustCompleted
-
Assiut UniversityNot yet recruitingDelayed and Secondary Postpartum Hemorrhage
Clinical Trials on Removable Uterine Compression Suture (RUCS)
-
Kanuni Sultan Suleyman Training and Research HospitalUnknownUterine Atony With Hemorrhage | Ovarian DysfunctionTurkey
-
Mansoura University HospitalCompleted
-
Alexandria UniversityCompleted
-
American University of Beirut Medical CenterCompletedPostpartum HemorrhageLebanon
-
Benha UniversityUnknownPostpartum HaemorrhageEgypt
-
Benha UniversityCompletedPlacenta Previa Complete CentralisEgypt
-
Tianjin Eye HospitalRecruitingPrimary PterygiumChina
-
University Tunis El ManarCompleted
-
Mansoura UniversityCompletedPost Partum Hemorrhage
-
Brigham and Women's HospitalNot yet recruiting