A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01161095|
Recruitment Status : Unknown
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was: Recruiting
First Posted : July 13, 2010
Last Update Posted : September 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Contraception Postpartum Period||Device: LNG-IUS||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||September 2011|
LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum
Mirena (Bayer)- Levonorgestrel-Intrauterine System
Active Comparator: Interval
LNG-IUS insertion after 6 weeks postpartum
Mirena (Bayer)- Levonorgestrel-Intrauterine System
- Continuation Rates [ Time Frame: 6 months ]
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.
- Pain at insertion [ Time Frame: 1 minute ]Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.
- Postpartum Depression [ Time Frame: 6 months ]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.
- Breastfeeding Status [ Time Frame: 6 months ]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.
- Postpartum weight retention [ Time Frame: 6 months ]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.
- Sexual Function [ Time Frame: 6 months ]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.
- Expulsion Rate [ Time Frame: 6 months ]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
- Bleeding Profile [ Time Frame: 6 months ]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.
- Infectious morbidity [ Time Frame: 6 months ]Postpartum endometritis and pelvic inflammatory disease will be tracked with record review and direct participant questioning at their postpartum appointment and at six months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161095
|United States, Arkansas|
|University of Arkansas for the Medical Sciences||Not yet recruiting|
|Little Rock, Arkansas, United States, 72205|
|Contact: Everett F Magann, MD 501-686-8345 email@example.com|
|United States, Virginia|
|Naval Medical Center||Recruiting|
|Portsmouth, Virginia, United States, 23507|
|Contact: Joshua D Dahlke, MD 757-953-4503 firstname.lastname@example.org|
|Principal Investigator: Joshua D Dahlke, MD|