Uterine HemorrhageNCT07870941
A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery
An observational study of Uterine Hemorrhage and Cardiovascular Diseases, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study aims to investigate uterine bleeding during menstruation in women taking antithrombotic medications after cardiac surgery. It will evaluate the proportion of patients with abnormal bleeding, such as heavy menstrual bleeding and prolonged menstrual periods, identify associated risk factors, and determine the… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Uterine Hemorrhage, Cardiovascular Diseases, Antithrombotic Drugs
- What is being tested?
- antithrombotic drugs
- How many people
- 1,308 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to 16 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women of childbearing age receiving oral antithrombotic therapy after cardiac surgery
Who may be able to join
- Female patients aged 18 to 49 years.
- Underwent cardiovascular surgery at our institution (e.g., coronary artery bypass grafting, heart valve repair/replacement, aortic surgery, congenital heart disease correction, heart transplantation).
- Absence of heavy menstrual bleeding (HMB) or prolonged menstrual bleeding (> 8 days) during the two consecutive menstrual cycles immediately prior to surgery.
- Experienced at least one complete menstrual bleeding episode within the predefined postoperative follow-up window.
- Receiving postoperative oral antiplatelet therapy (e.g., aspirin, clopidogrel) and/or oral anticoagulant therapy (e.g., rivaroxaban, warfarin).
- Concurrent use or non-use of estrogen/progestin modulation therapy is permitted.
Who cannot join
- Previous diagnosis of congenital bleeding or coagulation disorders (e.g., hemophilia, von Willebrand disease, congenital coagulation factor deficiencies, congenital thromboembolic diseases).
- History of endometrial ablation/resection, bilateral oophorectomy, or hysterectomy.
- Current diagnosis of gynecological malignancies requiring chemotherapy, radiotherapy, or targeted therapy.
- Pregnant or within 3 months postpartum prior to surgery or during the follow-up period.
- Currently undergoing or planning to undergo in vitro fertilization (IVF) treatment.
- Presence of psychiatric disorders, severe cognitive impairment, or other conditions precluding the effective completion of study assessments.
- Failure or inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Dandan Sun, master's degree, +86 64041990, sun.dandan1@zs-hospital.sh.cn
About this study
Official title: Incidence and Associated Factors of Abnormal Uterine Bleeding During Menstruation in Chinese Women of Childbearing Age Receiving Various Oral Antithrombotic Regimens After Cardiovascular Surgery: A Prospective Longitudinal Observational Study
This study aims to investigate uterine bleeding during menstruation in women taking antithrombotic medications after cardiac surgery. It will evaluate the proportion of patients with abnormal bleeding, such as heavy menstrual bleeding and prolonged menstrual periods, identify associated risk factors, and determine the characteristics of high-risk female patients.
- Being tested
- antithrombotic drugs
- Keywords
- Abnormal uterine bleeding, menstrual bleeding, cardiovascular surgery
- Medical subject headings
- Uterine Hemorrhage, Cardiovascular Diseases, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antithrombotic drugsDrug
Antithrombotic agents such as anticoagulants (e.g., warfarin, rivaroxaban) and antiplatelet drugs (e.g., aspirin, clopidogrel)
| Study group | Role | What they receive |
|---|---|---|
| Women receiving different types of antithrombotic therapy | Not described Receives: Drug: antithrombotic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of abnormal uterine bleeding in women was assessed using the Pictorial Blood Loss Assessment Chart (PBAC) developed by Higham
The Pictorial Blood Loss Assessment Chart (PBAC) is primarily used to evaluate the occurrence of prolonged menstruation (duration of menstrual bleeding ≥ 9 days) and/or heavy menstrual bleeding (PBAC score ≥ 100) in women.
Measured: Bleeding at the first menstrual period within two months after discharge
Secondary outcomes (1)
Assessment of Healthcare-Seeking Behaviors for Abnormal Uterine Bleeding Using Custom Items
In this study, custom questionnaire items were used to evaluate the clinical management of patients with AUB, including their healthcare-seeking behaviors (such as physician consultations, inpatient admissions, and emergency care) and specific therapeutic interventions (such as the dose reduction or interruption of oral antithrombotics, and blood transfusions).
Measured: Within 2 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start16 Sep 2026
- Primary completion16 Nov 2027 (estimated)
- Study completion16 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine HemorrhageStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870941
- Sponsor's protocol ID
- B2026-614R
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Associated Factors of Abnormal Uterine Bleeding During Menstruation in Chinese Women of Childbearing Age Receiving Various Oral Antithrombotic Regimens After Cardiovascular Surgery: A Prospective Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT07870941
- Acronym / sponsor ID
- B2026-614R
- Keywords
- Abnormal uterine bleeding, menstrual bleeding, cardiovascular surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,308 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 16 Nov 2027 (estimated)
- Study completion
- 16 Nov 2027 (estimated)
- First posted
- 13 Oct 2026 (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 study aims to investigate uterine bleeding during menstruation in women taking antithrombotic medications after cardiac surgery. It will evaluate the proportion of patients with abnormal bleeding, such as heavy menstrual bleeding and prolonged menstrual periods, identify associated risk factors, and determine the characteristics of high-risk female patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women receiving different types of antithrombotic therapy | – | Drug: antithrombotic drugs |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women of childbearing age receiving oral antithrombotic therapy after cardiac surgery
Key inclusion criteria (6 listed)
- Female patients aged 18 to 49 years.
- Underwent cardiovascular surgery at our institution (e.g., coronary artery bypass grafting, heart valve repair/replacement, aortic surgery, congenital heart disease correction, heart transplantation).
- Absence of heavy menstrual bleeding (HMB) or prolonged menstrual bleeding (> 8 days) during the two consecutive menstrual cycles immediately prior to surgery.
- Experienced at least one complete menstrual bleeding episode within the predefined postoperative follow-up window.
- Receiving postoperative oral antiplatelet therapy (e.g., aspirin, clopidogrel) and/or oral anticoagulant therapy (e.g., rivaroxaban, warfarin).
Key exclusion criteria (7 listed)
- Previous diagnosis of congenital bleeding or coagulation disorders (e.g., hemophilia, von Willebrand disease, congenital coagulation factor deficiencies, congenital thromboembolic diseases).
- History of endometrial ablation/resection, bilateral oophorectomy, or hysterectomy.
- Current diagnosis of gynecological malignancies requiring chemotherapy, radiotherapy, or targeted therapy.
- Pregnant or within 3 months postpartum prior to surgery or during the follow-up period.
- Currently undergoing or planning to undergo in vitro fertilization (IVF) treatment.
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 |
|---|---|---|
| antithrombotic drugsAntithrombotic agents such as anticoagulants (e.g., warfarin, rivaroxaban) and antiplatelet drugs (e.g., aspirin, clopidogrel) | Drug | Women receiving different types of antithrombotic therapy |
Primary outcome
The occurrence of abnormal uterine bleeding in women was assessed using the Pictorial Blood Loss Assessment Chart (PBAC) developed by Higham
Time frame: Bleeding at the first menstrual period within two months after discharge
The Pictorial Blood Loss Assessment Chart (PBAC) is primarily used to evaluate the occurrence of prolonged menstruation (duration of menstrual bleeding ≥ 9 days) and/or heavy menstrual bleeding (PBAC score ≥ 100) in women.
1 secondary outcome
Assessment of Healthcare-Seeking Behaviors for Abnormal Uterine Bleeding Using Custom Items
Time frame: Within 2 months after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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.
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 Uterine Hemorrhage and Cardiovascular Diseases, run by Shanghai Zhongshan Hospital at 1 site in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dandan Sun, Master's degree (+86 64041990, sun.dandan1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of abnormal uterine bleeding in women was assessed using the Pictorial Blood Loss Assessment Chart (PBAC) developed by Higham (time frame: Bleeding at the first menstrual period within two months after discharge). 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 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.