An interventional study of LNG-IUS in Contraception and Postpartum Period, sponsored by United States Naval Medical Center, Portsmouth. Withdrawn at 2 sites in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by United States Naval Medical Center, Portsmouth · Not applicable, Interventional, and Treatment
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).
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:
United States Naval Medical Center, Portsmouth is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications to the LNG-IUS include:
Any of these conditions would exclude the patient from receiving these forms of contraception in our study.
In addition the following intrapartum findings, the following would exclude the patient:
LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum
Device: LNG-IUS
LNG-IUS insertion after 6 weeks postpartum
Device: LNG-IUS
Mirena (Bayer)- Levonorgestrel-Intrauterine System
Continuation Rates
Primary objective: Determine if there is a difference in continuation rates at six months postpartum in women who have the Levonorgestrel Intrauterine System (LNG-IUS) inserted at two time periods: Immediate (after delivery of placenta to 72 hours postpartum) or Interval (after 6 weeks postpartum). Our analysis will be conducted on all randomized women on an intention to treat basis. Once insertion has occurred, evaluation at 6 months postpartum with the presence or absence of the LNG-IUS in the uterus will be determined to calculate the continuation rate.
Time frame: 6 months
Pain at insertion
Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.
Time frame: 1 minute
Postpartum Depression
Depression history will be determined from the initial data collection sheet upon entry into the study. The Edinburgh Postnatal Depression Scale will be filled out by the participant at their six week postpartum appointment (routine), and also at six months.
Time frame: 6 months
Breastfeeding Status
We will identify those who plan on breastfeeding their infants prior to discharge from the hospital. We will also determine the number of hours to Lactogenesis II (avg 40-50 hrs) via phone interview within one week from discharge. We will determine discontinuation rates and days to discontinuation of breastfeeding at six weeks and six months. We will also record infant weights at the postpartum appointment and at six months.
Time frame: 6 months
Postpartum weight retention
We will determine each participant's pre pregnancy BMI, BMI at admission to labor and delivery, and BMI at the postpartum appointment and at 6 months.
Time frame: 6 months
Sexual Function
We will determine the number of days from delivery to resumption of sexual intercourse. We will also have the participant complete the Female Sexual Function Index questionnaire (FSFI) at the postpartum appointment and at 6 months.
Time frame: 6 months
Expulsion Rate
Expulsion rate as well as resumption of contraception (whether LNG-IUS is replaced or another form of contraception is initiated) occurs at the postpartum appointment and at six months
Time frame: 6 months
Bleeding Profile
Each Participant will be asked to complete a monthly menstrual flow calendar to document light, medium, or heavy bleeding. These will be collected at the postpartum appointment and at six months.
Time frame: 6 months
Infectious morbidity
Postpartum endometritis and pelvic inflammatory disease will be tracked with record review and direct participant questioning at their postpartum appointment and at six months
Time frame: 6 months
This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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United States Naval Medical Center, Portsmouth