Intrauterine Adhesion
Conditions
Keywords
intrauterine balloon, uterine endometrial repair, intrauterine adhesion, aspirin
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 .
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.
Interventions
DRUGAspirin
low dose of Aspirin after operation
DEVICEintrauterine balloon
insert intrauterine balloon after operation
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometrial Thickness of All Participants in the Mid Menstrual Measured by Color Doppler Ultrasound | Within the first 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstruation Pattern(Improvement or No Significant Change) of All Participants | 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. |
| Reduction of American Fertility Society adhesion score at Second-look hysteroscopy of All Participants | 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. |
| Number of Participants With Pregnancy after operation | three years | — |
Countries
China
Outcome results
None listed