Postplacental LNG-IUD Ultrasound Use Study

NCT ID: NCT04474548

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-05
• Study Completion Date: 2023-09-30

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.

Conditions

IUD Insertion Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound use

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ultrasound use

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

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Perriera, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Danielle Tsevat, MD

Role: CONTACT

danielle.tsevat@jefferson.edu

215-955-5000

Lisa Perriera, MD, MPH

Role: CONTACT

lisa.perriera@jefferson.edu

Facility Contacts

Lisa Perriera, MD, MPH

Role: primary

lisa.perriera@jefferson.edu

Danielle Tsevat, MD

Role: backup

danielle.tsevat@jefferson.edu

Other Identifiers

20D.502

Identifier Type: -

Identifier Source: org_study_id