Postplacental LNG-IUD Ultrasound Use Study (PLUS)

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.

Study Overview

• Status: Recruiting
• Conditions: IUD Insertion Complication
• Intervention / Treatment: Other: Ultrasound use

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.

• Study Type: Interventional
• Enrollment (Anticipated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danielle Tsevat, MD; Phone Number: 215-955-5000; Email: danielle.tsevat@jefferson.edu
• Study Contact Backup: Name: Lisa Perriera, MD, MPH; Email: lisa.perriera@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Lisa Perriera, MD, MPH; Email: lisa.perriera@jefferson.edu
      • Contact: Danielle Tsevat, MD; Email: danielle.tsevat@jefferson.edu
      • Sub-Investigator: Danielle Tsevat, MD
      • Principal Investigator: Lisa Perriera, MD,MPH
      • Sub-Investigator: Rebecca Mercier, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound; For participants randomly assigned to ultrasound use, a bedside ultrasound will be performed using the trans-abdominal probe during and/or immediately after placement of the IUD. The distance from the IUD arms to the fundus will be measured with the ultrasound, and the IUD will be defined as being "in place" when the distance from the top of the IUD to the fundus is measured to be 3mm or less. If the distance is greater than 4mm, the provider may reposition the IUD manually or with a ring forceps.	Other: Ultrasound use; Ultrasound will be used to determine location of IUD after insertion.
No Intervention: No ultrasound; For participants randomly assigned to no ultrasound use, provider will insert the IUD with a ring forceps and will use palpation of the fundus to determine whether or not the IUD is likely in place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Lisa Perriera, MD, MPH, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Ultrasound; Postpartum; IUD
• Other Study ID Numbers: 20D.502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No