Postplacental LNG-IUD Ultrasound Use Study

  • End date
    Sep 26, 2023
  • participants needed
  • sponsor
    Thomas Jefferson University
Updated on 26 January 2021


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.


Participants will be screened and consented for participation in the study when they are admitted to Labor and Delivery for delivery and express desire for a post-placental LNG-IUD. If the patient consents for study participation and meets eligibility criteria above, she will be enrolled in the study after achieving vaginal delivery when she is randomized to either IUD insertion with ultrasound or without ultrasound use. See protocol for detailed description of IUD placement and ultrasound use.

After placement of IUD with or without ultrasound guidance, patients will be scheduled for a routine postpartum follow-up visit 6-10 weeks after delivery. At the postpartum follow-up visit, providers will assess for IUD expulsion with usual clinical practice, including history, pelvic exam, and additional imaging if IUD strings are not visualized on exam. Several attempts to contact participants who do not attend their postpartum visits will be made to attempt to reschedule appointments and conduct a phone questionnaire assessing for IUD expulsion.

Condition IUD Insertion Complication
Treatment Ultrasound use
Clinical Study IdentifierNCT04474548
SponsorThomas Jefferson University
Last Modified on26 January 2021


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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