Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT01161095
Brief Summary:
The primary objective of the investigators study is to determine if there is a difference in continuation rates at six months in women who are randomized to have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two possible time periods: Immediate (defined as after delivery of placenta to 72 hours postpartum) or Interval (defined as after 6 weeks postpartum).
Detailed Description:
The control arm of our study will be women who are randomized to receive LNG-IUS in the Interval time period. The study arm will consist of women randomized to receiving Immediate placement.
The investigators hypothesize that Immediate placement of IUD in the postpartum period will result in a 20% decrease in continuation rates at six months compared to Interval placement.
Secondary outcome measures that we will obtain include:
* Pain at the time of placement
* Postpartum Depression
* Breastfeeding status
* Postpartum weight retention
* Expulsion Rates
* Bleeding Profile
* Uterine Infection(Endometritis)
Study:
NCT01161095
Study Brief:
Protocol Section:
NCT01161095