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Pain relief study for IUD insertion pulled before it started

NCT ID NCT07044622

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test whether a small electrical device (TENS) could reduce pain when placing an IUD. It was designed for adults getting a new or replacement IUD. The study was withdrawn before enrolling anyone, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Patient Participants: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * English-speaking individual aged 18 years or older. * Presenting for IUD initiation or replacement during ambulatory care visits to the Yale Family Planning service and Center for Women's Health and Midwifery clinic. * Opting for either LNG 52mg or copper T380A IUD. Inclusion Criteria Provider Participants: * Review of the provider participant study Information Sheet and provision of verbal consent. * IUD insertion performed by Yale Family Planning and Center for Women's Health and Midwifery clinic faculty and fellows, as well as OB/GYN residents on their family planning rotation, with IUD insertion competency. * Performing an IUD insertion on a patient participant who meets all patient participant eligibility criteria Exclusion Criteria Patient Participants: * Contraindication to IUD initiation * Current Pelvic Infection * Distorted Uterine Anatomy (I.e., uterine septum, didelphys, uterine fibroids with cavity length greater than 12mm) * Pregnancy * Any other contraindications to IUD insertion as determined by the patient's clinical care staff. * Exclusionary criteria for study participation * Current IUD with no visible strings * Contraindication or allergy to ibuprofen * History of chronic pain disorder * Recent opioid use in the previous 30 days * History of cardiac arrhythmia * History of heart disease (i.e., atrial fibrillation, congestive heart failure) * Presence of an implantable device with an electrical discharge (i.e., pacemaker) * History of epilepsy * BMI \> 50 * History of TENS use * Planned pain intervention outside standard of care OR pre-procedure use of non-standard pain medication

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Center for Women's Health and Midwifery

    New Haven, Connecticut, 06519, United States

  • Yale Family Planning Clinic

    New Haven, Connecticut, 06519, United States

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