Vasomotor Symptoms in Post-Hysterectomy Women With Ovarian Conservation

NCT07064850 | Completed

• 1 other identifier: STU00223626
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn about vasomotor symptoms (such as hot flashes and night sweats) in the short-term period after a hysterectomy. The main question it aims to answer is: How common and severe are vasomotor symptoms shortly after surgery in people who have had a hysterectomy? Participants will complete a survey before surgery to assess baseline symptoms, and again 2 weeks after surgery to see if there are any changes.

Conditions

Vasomotor Symptoms

Keywords

Hysterectomy

Outcome Measures

Primary Outcomes (2)

• Changes in Vasomotor Symptom Frequency

  One primary outcome measure is the change in average vasomotor symptom frequency score from baseline (pre-operative) to 2 weeks post-operative. The symptoms evaluated will be hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how often they experience each symptom: never, rarely, sometimes, or often. For each symptom, average scores at baseline will be compared to scores collected 2 weeks after surgery to assess changes in symptom frequency.

  Baseline period to 2 weeks pre-operative

• Changes in Vasomotor Symptom Distress

  One primary outcome measure is the change in average vasomotor symptom distress scores from baseline (pre-operative) to 2 weeks post-operative. The symptoms assessed will include hot flashes, night sweats, increased sweating, sleep disturbances, and heart palpitations. Participants will rate how bothersome each symptom is using a 7-point Likert scale (0 = not at all bothersome, 6 = extremely bothersome). For each symptom, average distress scores at baseline will be compared to those collected 2 weeks post-operatively to evaluate changes in perceived symptom burden. Higher scores indicate greater symptom distress.

  Baseline period to 2 weeks pre-operative

Secondary Outcomes (1)

• Thematic Analysis of Patient-Reported Symptom Experiences

  Baseline period to 2 weeks post-operative

Eligibility Criteria

• Age: 35 Years - 50 Years
• Gender Eligibility Details: cisgender women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients scheduled for hysterectomy with ovarian conservation at an urban academic medical center. Participants will be recruited from the surgical gynecology service.

You may qualify if:

• years old
• Undergoing hysterectomy with at least one ovary conserved
• Ability to provide informed consent

You may not qualify if:

• (None specified)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60126, United States

Location

Study Officials

• Magdy P Milad, MD MS

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: May 29, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (1)