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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.
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.
Age
All ages
Sex
FEMALE
Healthy Volunteers
Yes
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Start Date
October 5, 2020
Primary Completion Date
October 1, 2022
Completion Date
September 1, 2023
Last Updated
October 22, 2020
254
ESTIMATED participants
Ultrasound use
OTHER
Lead Sponsor
Thomas Jefferson University
NCT05875571
NCT05594108
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03828760