Status:
UNKNOWN
Postplacental LNG-IUD Ultrasound Use Study
Lead Sponsor:
Thomas Jefferson University
Conditions:
IUD Insertion Complication
Eligibility:
FEMALE
Phase:
NA
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 ...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04474548
Start Date
October 5 2020
End Date
September 1 2023
Last Update
October 22 2020
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107