Postplacental LNG-IUD Ultrasound Use Study
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- STATUS
- Recruiting
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- End date
- Sep 26, 2023
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- participants needed
- 254
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- sponsor
- Thomas Jefferson University
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.
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.
Details
| Condition | IUD Insertion Complication |
|---|---|
| Treatment | Ultrasound use |
| Clinical Study Identifier | NCT04474548 |
| Sponsor | Thomas Jefferson University |
| Last Modified on | 26 January 2021 |
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