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

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

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Key information

Conditions

Abnormal Uterine Bleeding (AUB) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Metrorrhagia Pathologic Processes Pathological Conditions, Signs and Symptoms Postmenopausal Bleeding Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Vacuum Aspiration (MVA) Cannula

Device

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.

Pipelle Endometrial Suction Curette

Device

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 The sheath is introduced through the cervix, and the internal piston is withdrawn to create negative pressure suction while rotating the sheath 360 degrees to sample the uterine cavity, performed without local anesthesia or cervical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 outcomes

Diagnostic Yield for Endometrial Pathology

Time frame: At the time of histopathological assessment (up to 7 days post-procedure)

Proportion of participants receiving a definitive histopathological diagnosis (e.g., normal/proliferative/secretory, endometrial hyperplasia, endometrial polyp, or malignancy) based on microscopic evaluation of the tissue specimen.

Sponsors and collaborators

Lead sponsor

University of Health Sciences Lahore

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 4, 2026
Registry last updated: Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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