TerminatedNot Applicable

Postplacental LNG-IUD Ultrasound Use Study

Stopped: Inadequate recruitment

United States103 participantsStarted 2020-10-05

Plain-language summary

This study will enroll women planning to have an intrauterine device (IUD) placed for contraception immediately following a vaginal delivery. Women will be randomized to have this procedure done with or without ultrasound guidance. We intend to determine if the routine use of ultrasound to confirm device position reduces the rates of IUD expulsion.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients admitted to Thomas Jefferson University Labor and Delivery who desire and consent to post-placental LNG-IUD placement * English- and Spanish- speaking patients Exclusion Criteria: * Patients undergoing planned or unplanned Cesarean delivery * Patients who have an allergy or other contraindication to use of LNG-IUD * Patients who tested positive for gonorrhea or chlamydia during pregnancy without treatment and a subsequent negative test of cure * Patients with one or more leiomyomata greater than 3 cm in diameter impinging the uterine cavity * Clinical diagnosis of chorioamnionitis or presumed chorioamnionitis in labor * Postpartum hemorrhage as defined by need for transfusion, estimated blood loss greater than 1000mL, or use of 3 or more doses of uterotonic medications

What they're measuring

IUD expulsion

Timeframe: 6-10 weeks

Trial details

NCT IDNCT04474548

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More IUD Insertion Complication trials