Intrauterine Stent Placement Following Hysteroscopic Septum Resection

Conditions

• Intrauterine Adhesion

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Intraoperative placement of an inflated intrauterine pediatric foley catheter — PROCEDURE
  Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
• No Catheter placement — PROCEDURE
  No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon
• Hormonal Therapy Agent — 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 — 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

Study Details

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.

Key Dates

First listed

Jun 24, 2025

Start date

May 14, 2026

Status verified

Jun 2026

Primary completion

Sep 30, 2029

Completion

Dec 31, 2031

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Active Comparator: Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter
  No placement of an inflated intrauterine pediatric foley catheter

Primary Outcome Measure

The rate of intrauterine adhesion formation following hysteroscopic septoplasty [ Time Frame: 12 weeks ]

Central Contacts

• Rodriq Stubbs, NP, MSN
  646-962-3276
  [email protected]
• Sarah Cambria
  646-962-2961
  [email protected]

Locations (3)

Find similar trials in Little Rock, AR