Clinical trial NCT04474548: Postplacental LNG-IUD Ultrasound Use Study
Official title: Postplacental LNG-IUD Ultrasound Use Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IUD Insertion Complication
Keywords: IUD
Postpartum
Ultrasound
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 254
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: IUD expulsion
timeFrame: 6-10 weeks
Secondary outcomes:
measure: IUD insertion complication
timeFrame: 6-10 weeks
measure: Receiving IUD
timeFrame: 6-10 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Lisa Perriera, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: