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Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

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ClinicalTrials.gov Identifier: NCT02744716
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
This study aimed To investigate the effects of estrogen in combination with aspirin and intrauterine balloon on the uterine endometrial repair and reproductive prognosis in patients after surgery for severe intrauterine adhesion .

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Drug: Aspirin Device: intrauterine balloon Not Applicable

Detailed Description:
This cohort study was conducted to investigate whether aspirin could promote the endometrial growth and repair, reduce the recurrence of intrauterine adhesion and improve the menstruation and reproductive prognosis after surgery for severe intrauterine adhesion. Menstruation was evaluated for the first time with a method similar to visual analogue scale (VAS) in which the menstruation was assessed by the patients themselves with 0 as amenorrhea and 100 as normal menstruation. This evaluation avoids the vague terms (such as large or small menstrual blood volume) in previous evaluations and considers the individual difference in menstrual blood volume and different understanding about the menstrual blood volume. Thus, this evaluation is easy to master, quantify and analyze.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Aspirin and Intrauterine Balloon on the Post-operative Uterine Endometrial Repair and Reproductive Prognosis in Patients With Severe Intrauterine Adhesion: a Prospective Cohort Study
Study Start Date : May 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: non-balloon group
with aspirin
Drug: Aspirin
low dose of Aspirin after operation
Other Name: low dose of Aspirin

Experimental: balloon group
with aspirin and intrauterine balloon
Drug: Aspirin
low dose of Aspirin after operation
Other Name: low dose of Aspirin

Device: intrauterine balloon
insert intrauterine balloon after operation
Other Name: Balloon stent

No Intervention: control group
without aspirin and intrauterine balloon



Primary Outcome Measures :
  1. Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound [ Time Frame: Within the first 3 months after surgery ]

Secondary Outcome Measures :
  1. Menstruation Pattern(Improvement or No Significant Change) of All Participants [ Time Frame: Within the first 3 months after surgery ]
    A method similar to VAS was employed for the evaluation of post-operative menstruation with 0 as amenorrhea and 100 as normal menstruation.

  2. Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants [ Time Frame: Within the first 3 months after surgery ]
    The severity and extent of intrauterine adhesions were scored according to a classification system recommended by the American Fertility Society (AFS) (1988 version) [7]. A score of 1-4 was considered to represent mild adhesions, a score of 5-8 was considered to represent moderate adhesions and a score of 9-12 represented severe adhesions.

  3. Number of Participants With Pregnancy after operation [ Time Frame: three years ]


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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pre-operative adhesion score was ≥9
  • The prior menstrual cycle was regular, and the sex hormone was normal
  • Patients had fertility requirement
  • Male semen examination showed normal; (5) There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery

Exclusion Criteria:

  • Pre-operative adhesion score was <9
  • Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
  • Patients had no fertility requirement
  • Patients had male factor infertility
  • Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744716


Locations
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China, Guangdong
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: chen yu qing, Deputy chief First Affiliated Hospital, Sun Yat-Sen University

Publications:

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Responsible Party: Yuqing Chen, Deputy chief physician, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02744716     History of Changes
Other Study ID Numbers: aspirin
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University:
intrauterine balloon
uterine endometrial repair
intrauterine adhesion
aspirin

Additional relevant MeSH terms:
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Aspirin
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics