An interventional study of Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter in Asherman Syndrome, sponsored by Wenzhou Medical University. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
49 studies on the registry are indexed under Gynatresia; 17 are open to participants now.
This study's enrollment of 171 is above the median of 95 across 41 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Wenzhou Medical University is the lead sponsor of 93 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.
Device: Intrauterine balloon
Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.
Device: Intrauterine Contraceptive Device Plus Foley Catheter
After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
Also known as: Cook balloon
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.
Also known as: Intrauterine Device Plus Foley Catheter
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
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)
| Milestone | Intrauterine Balloon | Intrauterine Contraceptive Device Plus Foley Catheter |
|---|---|---|
| Started | 83 | 88 |
| Completed | 62 | 56 |
| Not completed | 21 | 32 |
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.
| Units on a scale | Intrauterine Balloon | Intrauterine Device Plus Foley Catheter |
|---|---|---|
| the AFS Score at Second-look Hysteroscopy | 6.5 (1 to 10) | 8 (3 to 12) |
Collected over 6 months to 1 year. Non-serious events are listed at a 2.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intrauterine Balloon | 0/83 (0%) | 0/83 (0%) | 21/83 (25.3%) |
| IUD Plus Foley Catheter | 0/88 (0%) | 0/88 (0%) | 32/88 (36.4%) |
| Event | Intrauterine Balloon | IUD Plus Foley Catheter |
|---|---|---|
| refuse to have second-look hysteroscopyInvestigations | 9/83 | 21/88 |
| suffered from moderate to severe postoperative painInjury, poisoning and procedural complications | 12/83 | 3/88 |
| Not meeting inclusion criteriaInvestigations | 5/83 | 5/88 |
| Declined to participateInvestigations | 4/83 | 4/88 |
| Protocol violationInvestigations | 3/83 | 2/88 |
| Age, Continuous(year) | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| Mean | 31.69 ± 5.268 | 32.63 ± 6.125 | 32.14 ± 5.685 |
| Sex: Female, Male(Participants) | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| Female | 62 | 56 | 118 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 62 | 56 | 118 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| China | 62 | 56 | 118 |
| Parity(Births) | Intrauterine Balloon | IUD Plus Foley Catheter | Total |
|---|---|---|---|
| Mean | 0.484 ± 0.565 | 0.554 ± 0.536 | 0.517 ± 0.551 |
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Wenzhou Medical University