Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06891794
Eligibility Criteria:
Inclusion Criteria:
* Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
* Able to review and sign study consents in English
* Generally healthy
Exclusion Criteria:
* History of any prior births, miscarriages, or abortions after 16 weeks' gestation
* Currently pregnant, known or suspected
* Current stringless IUD in place
* Participants premedicated with misoprostol
* History of chronic pelvic pain which patients take daily medication for
* History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
* Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
* Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
* Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
* Previous IUD placement or failed attempt of an IUD placement
* Weight \< 54.4kg (120 lbs)
* Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
* Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
* Any planned concomitant procedures, such as dilation and curettage (D\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
* Illicit drug use
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06891794
Study Brief:
Protocol Section:
NCT06891794