About this trial
The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 and above
Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound
Disqualifiers
Unwilling or unable to provide informed consent
History of prior uterine septum resection
History of prior transmural uterine surgery
Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
Trial design
Parallel
Treatments tested in this trial
Intraoperative placement of an inflated intrauterine pediatric foley catheter
Procedure/SurgeryIntraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
No Catheter placement
Procedure/SurgeryNo Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon
Hormonal Therapy Agent
Drug2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)
Oral antibiotics
Drug100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
Treatment groups
Trial outcomes
Primary outcomes
The rate of intrauterine adhesion formation following hysteroscopic septoplasty
Secondary outcomes
Number of participants with Intraoperative complications
Number of participants with postoperative complications
Number of subjects completing postop intervention-hormone use
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit
Sponsors and contacts
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