Intrauterine Stent Placement Following Hysteroscopic Septum Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement, Hormonal Therapy Agent, Oral antibiotics.
- Who it may be relevant to
- Registry conditions: Intrauterine Adhesion. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Overview
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.
Interventions
- Procedure 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. - Procedure No Catheter placement
No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon - Drug 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) - 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
Primary outcome measures
- The rate of intrauterine adhesion formation following hysteroscopic septoplasty [Time frame: 12 weeks]
Secondary outcome measures (6)
- Number of participants with Intraoperative complications [Time frame: 12 weeks]
- Number of participants with postoperative complications [Time frame: 12 weeks]
- Number of subjects completing postop intervention-hormone use [Time frame: 12 weeks]
- Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit [Time frame: 12 weeks]
- Long Term Reproductive Outcome [Time frame: 3 years]
- Surgeon assessment of intervention modality [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- Arkansas Fertility & Gynecology — Little Rock
- Weill Cornell Medicine — New York
- University Hospitals — Cleveland
Identifiers
NCT: NCT07032506 · 24-04027291