Intrauterine Adhesion
Conditions
Brief summary
The aim of the study is to find out the benefit of the platelet-rich plasma in preventing reformation of intrauterine adhesions after adhesiolysis in cases of Asherman syndrome
Detailed description
Patients fulfilling criteria will be randomized into three equal groups. The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study. Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. in the second group, adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter covered by freeze-dried amniotic graft and will be inflated and left for 2 weeks. In the third group, Adhesiolysis will be followed by insertion of intrauterine Foley balloon catheter that will be inflated and left for 2 weeks. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
Interventions
BIOLOGICALplatelet rich plasma
Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
COMBINATION_PRODUCTamniotic membrane graft group
amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
DEVICEIntrauterine balloon
intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The patients who are diagnosed previously with severe AS will choose an envelope which determines the treatment method. There will be 60 envelops assigning for the groups mixed together in one box. This will ensure a randomized allocation of patients to either group of this study. Hysteroscopy adhesiolysis will be done to all participants in the study. in the first group, Adhesiolysis will be followed by intrauterine use of PRP then insertion of Foley balloon catheter. in the second group, adhesiolysis will be followed by insertion of Foley balloon catheter covered by freeze-dried amniotic graft. In the third group, Adhesiolysis will be followed by insertion of Foley balloon catheter. All foley ballon removed 2 weeks postoperative. All patients will be given antibiotics and hormonal treatment. Also, they will be given low dose aspirin and sildenafil 50mg daily.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
Severe intrauterine synechia confirmed by hysteroscopy * age group from 20 to 40 years
Exclusion criteria
* Hemoglobin less than 11 g/dl * Platelet less than 150000/mm3 * Patients taking anticoagulants * Patients taking NSAID in the 15 days prior to the procedure * Active cervical or uterine infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of intrauterine adhesions | after one month | Grade of intrauterine adhesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| menstruation | within three months postoperative | amount of menstrual blood change |
Countries
Egypt
Outcome results
None listed