Postplacental LNG-IUD Ultrasound Use Study

NCT04474548 | Unknown

• 1 other identifier: 20D.502
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

IUD Insertion Complication

Keywords

IUD; Postpartum; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• IUD insertion complication

  6-10 weeks

• Receiving IUD

  6-10 weeks

Study Arms (2)

Ultrasound

EXPERIMENTAL

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

No ultrasound

NO INTERVENTION

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.

Interventions

Ultrasound use OTHER

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

Ultrasound

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted to Thomas Jefferson University Labor and Delivery who desire and consent to post-placental LNG-IUD placement
• English- and Spanish- speaking patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Study Officials

• Lisa Perriera, MD, MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Tsevat, MD

CONTACT

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

Lisa Perriera, MD, MPH

CONTACT

lisa.perriera@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 17, 2020
• Study Start: October 5, 2020
• Primary Completion: October 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)