- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161095
A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Not yet recruiting
- University of Arkansas for the Medical Sciences
-
Contact:
- Everett F Magann, MD
- Phone Number: 501-686-8345
- Email: efmagann@uams.edu
-
-
Virginia
-
Portsmouth, Virginia, United States, 23507
- Recruiting
- Naval Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All women >37 weeks gestation who desire LNG-IUS for postpartum contraception who do not have a contraindication as described below will be offered participation in our study.
Exclusion Criteria:
Contraindications to the LNG-IUS include:
- Pregnancy or suspicion of pregnancy
- Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
- Postpartum endometritis within the past 3 months
- Known or suspected uterine or cervical neoplasia or unresolved, abnormal pap smear
- untreated acute cervicitis or vaginitis including bacterial vaginosis or other lower genital tract infections
- acute liver disease or liver tumor
- hypersensitivity to any component of the product
- known or suspected carcinoma of the breast
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:
- Delivery <37 weeks
- Intrapartum chorioamnionitis (defined as maternal fever >100.4 and two of the following conditions: Maternal leukocytosis (greater than 15,000 cells/cubic millimeter), Maternal tachycardia (greater than 100 beats/minute), Fetal tachycardia (greater than 160 beats/minute), Uterine tenderness, Foul odor of the amniotic fluid
- Postpartum Hemorrhage (defined as >500cc EBL for spontaneous vaginal delivery or >1000cc for cesarean delivery)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain at insertion
Time Frame: 1 minute
|
Pain will be measured using the validated Visual Analog Scale (VAS) at the time of insertion.
|
1 minute
|
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.
|
6 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.
|
6 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.
|
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.
|
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
|
6 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.
|
6 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
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NMCP.2010.0074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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