Asherman Syndrome
Conditions
Keywords
intrauterine balloon, Intrauterine Device Plus Foley Balloon Catheter, Asherman Syndrome
Brief summary
This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.
Detailed description
Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion. The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later. The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
Interventions
DEVICEIntrauterine balloon
After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
DEVICEIntrauterine Contraceptive Device Plus Foley Catheter
After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.
Sponsors
Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe intrauterine adhesion (AFS score ≥5） * Agreement to have a second-look hysteroscopy * no previous history of hysteroscopic adhesiolysis
Exclusion criteria
* Minimal adhesion (AFS score\<5) * Previous hysteroscopic adhesiolysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the AFS Score at Second-look Hysteroscopy | 2 or 3 months after the surgery | The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is. |
Countries
China
Participant flow
Recruitment details
all patients were recruited from 1st affiliated hospital of Wenzhou Medical University. Inclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)
Pre-assignment details
1. not meeting inclusion criteria 2. declined to participate
Participants by arm
| Arm | Count |
|---|---|
| Intrauterine Balloon After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions. | 62 |
| IUD Plus Foley Catheter Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. | 56 |
| Total | 118 |
Baseline characteristics
| Characteristic | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| Age, Continuous | 31.69 year STANDARD_DEVIATION 5.268 | 32.63 year STANDARD_DEVIATION 6.125 | 32.14 year STANDARD_DEVIATION 5.685 |
| Parity | 0.484 Births STANDARD_DEVIATION 0.565 | 0.554 Births STANDARD_DEVIATION 0.536 | 0.517 Births STANDARD_DEVIATION 0.551 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 62 Participants | 56 Participants | 118 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 62 participants | 56 participants | 118 participants |
| Sex: Female, Male Female | 62 Participants | 56 Participants | 118 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 88 |
| other Total, other adverse events | 21 / 83 | 32 / 88 |
| serious Total, serious adverse events | 0 / 83 | 0 / 88 |
Outcome results
Primary
the AFS Score at Second-look Hysteroscopy
The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
Time frame: 2 or 3 months after the surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intrauterine Balloon | the AFS Score at Second-look Hysteroscopy | 6.5 Units on a scale |
| Intrauterine Device Plus Foley Catheter | the AFS Score at Second-look Hysteroscopy | 8 Units on a scale |
Comparison: Data analysis was performed with SPSS version 22.0, using two-sided test, and a p value \< 0.05 was considered statistically significant.p-value: <0.05t-test, 2 sided