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RecruitingNCT07870941Updated Oct 13, 2026

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

An observational study in Uterine Hemorrhage, Cardiovascular Diseases and Antithrombotic Drugs, sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Shanghai Zhongshan Hospital · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,308
Ages
18 Years to 49 Years
Sex
Female
01

Study 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 characteristics of high-risk female patients.

02

Conditions studied

  • Uterine Hemorrhage
  • Cardiovascular Diseases
  • Antithrombotic Drugs

Keywords

  • Abnormal uterine bleeding
  • menstrual bleeding
  • cardiovascular surgery
03

In context

Uterine Hemorrhage

160 studies on the registry are indexed under Uterine Hemorrhage; 21 are open to participants now.

This study's planned enrollment of 1,308 is above the median of 122 across 41 observational studies indexed under Uterine Hemorrhage.

Browse Uterine Hemorrhage studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women of childbearing age receiving oral antithrombotic therapy after cardiac surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,308 participants (estimated)
Patient registry
No

Groups and cohorts

  • Women receiving different types of antithrombotic therapy

    Drug: antithrombotic drugs

Interventions

  • Drugantithrombotic drugs

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Nov 2027, 14 months after the start.

Of 16 observational studies under Uterine Hemorrhage, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 14 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2026
First posted
Oct 13, 2026
StartActual
Sep 16, 2026
Primary completionEst.
Nov 16, 2027
CompletionEst.
Nov 16, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870941
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Sep 16, 2026
Primary completion
Nov 16, 2027 (estimated)
Completion
Nov 16, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Dandan Sun, Master's degree
Contact
sun.dandan1@zs-hospital.sh.cn
+86 64041990

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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