A Study on Abnormal Menstrual Bleeding in Chinese Women of Childbearing Age Taking Antithrombotic Drugs After Cardiovascular Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-49
SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Women of childbearing age receiving oral antithrombotic therapy after cardiac surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • antithrombotic drugs

    Drug

    Antithrombotic agents such as anticoagulants (e.g., warfarin, rivaroxaban) and antiplatelet drugs (e.g., aspirin, clopidogrel)

Treatment groups

1,308 Participants
are divided into 1 treatment group
Group A: Women receiving different types of antithrombotic therapy1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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).

Time frame
Within 2 months after discharge

Other outcomes

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