Abnormal menstrual bleeding in women on antithrombotic drugs after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will enroll women aged 18 to 49 who had cardiovascular surgery and are taking oral antithrombotic therapy. It aims to estimate how common abnormal uterine bleeding is after surgery, including heavy or prolonged menses, and to identify patient characteristics that are associated with higher risk. Data will be collected on postoperative bleeding patterns, antithrombotic regimens, and potential risk factors. The findings could help clinicians recognize which patients may need closer monitoring or management of menstrual bleeding while on antithrombotic therapy. The study is based at Zhongshan Hospital, Shanghai, with no listed external collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Dandan Sun, Master's degree
• Email: sun.dandan1@zs-hospital.sh.cn
• Phone: +86 64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.