A Multicenter Analysis of Levonorgestrel-Intrauterine System (LNG-IUS) Use in the Postpartum Period

September 29, 2010 updated by: United States Naval Medical Center, Portsmouth
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).

Study Overview

Status

Unknown

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Not yet recruiting
        • University of Arkansas for the Medical Sciences
        • Contact:
    • Virginia
      • Portsmouth, Virginia, United States, 23507
        • Recruiting
        • Naval Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

March 1, 2011

Study Completion (Anticipated)

September 1, 2011

Study Registration Dates

First Submitted

July 12, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 30, 2010

Last Update Submitted That Met QC Criteria

September 29, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

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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