A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Weill Medical College of Cornell University
Summary
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.
Description
This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those w…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Individuals in whom complete septum resection is unable to be performed…
Interventions
- ProcedureIntraoperative placement of an inflated intrauterine pediatric foley catheter
Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
- ProcedureNo Catheter placement
No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon
- DrugHormonal Therapy Agent
2 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)
- DrugOral antibiotics
100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
Locations (3)
- Arkansas Fertility & GynecologyLittle Rock, Arkansas
- Weill Cornell MedicineNew York, New York
- University HospitalsCleveland, Ohio