Postplacental LNG-IUD Ultrasound Use Study

IUD Insertion Complication Clinical Trial

— PLUS  

Official title:

Postplacental LNG-IUD Ultrasound Use Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474548
• Other study ID #: 20D.502
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: September 2023

Study information

• Verified date: October 2020
• Source: Thomas Jefferson University
• Contact: Danielle Tsevat, MD
• Phone: 215-955-5000
• Email: danielle.tsevat[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: September 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Other:
• Ultrasound use
Ultrasound will be used to determine location of IUD after insertion.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-10 weeks
Secondary	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	6-10 weeks
Secondary	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	6-10 weeks