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Not yet recruiting NCT07745595

Low Dose Aspirin vs Placebo in Prevention of Recurrent Spontaneous Preterm Labour

No phase Interventional Abnormal Uterine Bleeding (AUB) Menorrhagia Postmenopausal Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual Vacuum Aspiration (MVA) Cannula, Pipelle Endometrial Suction Curette.
Who it may be relevant to
Registry conditions: Abnormal Uterine Bleeding (AUB), Menorrhagia, Postmenopausal Bleeding. Basic parameters: from 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of Low Dose Aspirin vs Placebo in the Prevention of Recurrent Spontaneous Preterm Labou

Overview

Abnormal Uterine Bleeding (AUB) is a common gynecological issue affecting women globally, requiring endometrial tissue sampling to evaluate underlying causes such as hyperplasia, polyps, or malignancy. While Pipelle biopsy is a widely used outpatient sampling technique, its single-use nature makes it relatively expensive in resource-limited settings. Manual Vacuum Aspiration (MVA) using a 4 mm flexible cannula is an inexpensive, reusable alternative that requires no cervical dilation or electricity, but direct comparative evidence between MVA and Pipelle remains limited

Interventions

  • Device Manual Vacuum Aspiration (MVA) Cannula
    Endometrial sampling performed using a 4 mm flexible polyethylene Manual Vacuum Aspiration (MVA) cannula attached to a double-valve MVA syringe. The procedure is conducted in an outpatient setting under aseptic conditions without local anesthesia or cervical dilation.
  • Device Pipelle Endometrial Suction Curette
    Endometrial biopsy performed using a standard flexible Pipelle device. The sheath is introduced through the cervix, and the internal piston is withdrawn to create negative pressure suction while rotating the sheath 360 degrees to sample the uterine cavity, performed without local anesthesia or cervical dilation.

Primary outcome measures

  • Diagnostic Yield for Endometrial Pathology [Time frame: At the time of histopathological assessment (up to 7 days post-procedure)]

Eligibility criteria

Inclusion criteria

  • Married women aged 35 years and above.
  • Presentation with abnormal uterine bleeding (AUB), including metrorrhagia, menorrhagia, or postmenopausal bleeding.
  • Clinical indication for endometrial sampling for diagnostic evaluation.
  • Patient fit for both MVA and Pipelle procedures with no contraindications to either method.

Exclusion criteria

  • Pregnancy or suspicion of pregnancy.
  • Active acute pelvic inflammatory disease (PID) or active lower/upper genital tract infection.
  • Current use of anticoagulant therapy or presence of underlying bleeding/coagulation disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07745595 · Exp143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗