Postplacental LNG-IUD Ultrasound Use Study

Thomas Jefferson University254 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

254

Conditions

IUD Insertion Complication

Interventions

Ultrasound useOTHER

Ultrasound will be used to determine location of IUD after insertion.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

IUD expulsion

The primary objective is to determine whether the expulsion rate of the LNG-releasing IUD within a 6-10 week period would be different when inserted with ultrasound guidance or with no ultrasound confirmation

Time frame: 6-10 weeks

Secondary Outcomes

IUD insertion complication

To determine if rate of complication with insertion, such as uterine perforation rates, infection rates, or bleeding rates, are different with or without ultrasound guidance

Time frame: 6-10 weeks

Receiving IUD

To determine what percentage of patients who desire a post-placental IUD after delivery are able to receive one and to determine if enrolled patients that cannot get an immediate post-placental IUD get an IUD within 6-10 weeks after delivery

Time frame: 6-10 weeks

Central Contacts

Danielle Tsevat, MD

CONTACT

215-955-5000 danielle.tsevat@jefferson.edu

Lisa Perriera, MD, MPH

CONTACT

lisa.perriera@jefferson.edu

Data from ClinicalTrials.gov

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