Intrauterine Stent Placement Following Hysteroscopic Septum Resection

NCT ID: NCT07032506

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2031-12-31

Brief 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.

Detailed 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 with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.

Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:

Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.

Conditions

Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention A:Intraoperative 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.

Group Type: EXPERIMENTAL

Intraoperative placement of an inflated intrauterine pediatric foley catheter

Intervention Type: PROCEDURE

Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.

Hormonal Therapy Agent

Intervention Type: DRUG

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)

Oral antibiotics

Intervention Type: DRUG

100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place

Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter

No placement of an inflated intrauterine pediatric foley catheter

Group Type: ACTIVE_COMPARATOR

No Catheter placement

Intervention Type: PROCEDURE

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

Hormonal Therapy Agent

Intervention Type: DRUG

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)

Interventions

Intraoperative 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.

Intervention Type: PROCEDURE

No Catheter placement

No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon

Intervention Type: PROCEDURE

Hormonal 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)

Intervention Type: DRUG

Oral 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

Intervention Type: DRUG

Eligibility Criteria

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 as a single procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn Schattman, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Arkansas Fertility & Gynecology

Little Rock, Arkansas, United States

Weill Cornell Medicine

New York, New York, United States

University Hospitals

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Rodriq Stubbs, NP, MSN

Role: CONTACT

res2011@med.cornell.edu

646-962-3276

Sarah Cambria

Role: CONTACT

sac7011@med.cornell.edu

646-962-2961

Facility Contacts

Christopher Moutos, MD

Role: primary

res2011@med.cornell.edu

(501) 534-3764

Rodriq Stubbs, NP

Role: primary

res2011@med.conrell.edu

Mindy Christianson, MD

Role: primary

christm12@ccf.org

(216) 672-1427

Other Identifiers

24-04027291

Identifier Type: -

Identifier Source: org_study_id