Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start

00151440

This is a prospective clinical research study to test the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception (EC) and same-day start use that will enroll people receiving care at Planned Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test effectiveness (how well it works in the real world) in a larger, heterogenous population in a usual care setting where participants select their method and are not randomly assigned to it. The study population will include people initiating an LNG 52 mg IUD and meet inclusion and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood Federation of America was the first major healthcare organization to change its practice to incorporate the changes we are studying here. As such, all study participants will be offered the opportunity to choose the interventional IUD at the site they visit. The primary outcome is pregnancy status one month after LNG IUD placement by home urine pregnancy test or clinical record review. Participant follow up concludes one month after enrollment. The purpose of this study is to demonstrate reproducibility of earlier findings in a more heterogenous population. As such, IUD placement is not a study procedure but a component of clinical care. The study interventions only involve study participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or same day start.

2022-11-07

2027-03-31

2027-07-31

Recruiting

Early phase I

1404

Inclusion Criteria: * Meet clinic eligibility for IUD placement * Have a LNG 52 mg IUD placed for either emergency contraception (had unprotected intercourse in the last 5 days) OR Same-day start, \>7 days since the onset of last menstrual period and have no report of unprotected intercourse in the last 5 days * Negative high sensitivity urine pregnancy test prior to IUD placement. * No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016 * Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had penile-vaginal intercourse at least once in the last month. * Fluent in English or Spanish * Working Cell Phone number that receives text messages * Willing to comply with the study requirements including providing 1-month follow up data including a urine pregnancy test result one month after IUD placement Exclusion Criteria: * Current pregnancy * Currently Breastfeeding * Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month) * Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks * Use of oral emergency contraception in last 5 days * Vaginal bleeding of unknown etiology * Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months * Planned use of any non-contraceptive estrogen, progesterone, or testosterone * Acute cervicitis * Known abnormalities of the uterus that distort the uterine cavity * Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks * Ended pregnancy over 20 weeks gestational age within the last 6 weeks

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2024-05-08