Evaluating the Safety and Efficacy of RUCS in PPH (RUCS-PPH)

August 4, 2025 updated by: Havva Betül Bacak

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Gaziosmanpasa Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Havva Betül Bacak

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: fatih irice, md, University of Health Sciences, Gaziosmanpaşa Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GopRucs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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