Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion

April 16, 2016 updated by: Yuqing Chen, First Affiliated Hospital, Sun Yat-Sen University

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

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 .

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: non-balloon group
with aspirin
low dose of Aspirin after operation
Other Names:
  • low dose of Aspirin
Experimental: balloon group
with aspirin and intrauterine balloon
low dose of Aspirin after operation
Other Names:
  • low dose of Aspirin
insert intrauterine balloon after operation
Other Names:
  • Balloon stent
No Intervention: control group
without aspirin and intrauterine balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound
Time Frame: Within the first 3 months after surgery
Within the first 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 3 months after surgery
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.
Within the first 3 months after surgery
Number of Participants With Pregnancy after operation
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: chen yu qing, Deputy chief, First Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 9, 2016

First Submitted That Met QC Criteria

April 16, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 16, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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