Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by United States Naval Medical Center, Portsmouth.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
United States Naval Medical Center, Portsmouth
Information provided by:
United States Naval Medical Center, Portsmouth
ClinicalTrials.gov Identifier:
NCT01088178
First received: February 25, 2010
Last updated: September 29, 2010
Last verified: September 2010
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Purpose
The investigators study is a prospective randomized trial of women undergoing the levonorgestrel intrauterine system (LNG-IUS: Mirena©, Bayer) at three separate time periods: immediate post placental (IPP) defined as insertion within 10 min delivery of placenta, early post partum (EP) defined as insertion after 10 min but within 72hrs postpartum, or interval (INT) insertion defined as insertion after 6wks postpartum. This is a pilot study in preparation for a multicenter, prospective randomized study of long-acting reversible contraception in the postpartum period.
| Condition | Intervention |
|---|---|
|
Contraception |
Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals |
Resource links provided by NLM:
Further study details as provided by United States Naval Medical Center, Portsmouth:
Primary Outcome Measures:
- Continuation Rates of the LNG-IUS when placed postpartum at three time periods [ Time Frame: at 6 months ] [ Designated as safety issue: No ]Determine if there is a difference in continuation rates at 6 months between participants who had the LNG-IUS placed at three different time periods: Immediate Postplacental (within 10 minutes from delivery of placenta), Early Postpartum (after 10 minutes but before 48 hours postpartum) , and Interval (after 6 weeks postpartum).
Secondary Outcome Measures:
- Expulsion rate of the LNG-IUS when placed postpartum at three time periods [ Time Frame: at 3 weeks ] [ Designated as safety issue: No ]Determine if there is a difference in expulsion rates at the three different time periods of placement.
- Pain at placement [ Time Frame: at 1 minute ] [ Designated as safety issue: No ]Determine if there is a difference pain as assessed with the Visual Analog Scale at the time of placement of the LNG-IUS at three time period: Immediate Postplacental, Early Postpartum, or Interval.
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Immediate Postplacental
Within 10 minutes from delivery of placenta
|
Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
|
|
Experimental: Early Postpartum
After 10 minutes from delivery of placenta but within 48hrs from delivery
|
Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
|
|
Experimental: Interval
After 6 weeks postpartum
|
Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)
Placement of Mirena at given intervals during the postpartum period
|
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All reproductive age women who express a desire for the LNG-IUS (Mirena©) at routine questioning at their 36-38 week prenatal appointment or upon admission to labor and delivery are eligible for 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 our study.
- Delivery <36 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)
- Cesarean delivery if randomized to IPP or EP placement
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088178
Contacts
| Contact: Joshua D Dahlke, MD | 757-953-4503 | joshua.dahlke@med.navy.mil |
Locations
| United States, Virginia | |
| Naval Medical Center | Recruiting |
| Portsmouth, Virginia, United States, 23507 | |
| Contact: Joshua D Dahlke, MD joshua.dahlke@med.navy.mil | |
| Principal Investigator: Joshua D Dahlke, MD | |
Sponsors and Collaborators
United States Naval Medical Center, Portsmouth
More Information
No publications provided by United States Naval Medical Center, Portsmouth
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | LCDR Joshua D. Dahlke MD, Naval Medical Center Portsmouth Virginia |
| ClinicalTrials.gov Identifier: | NCT01088178 History of Changes |
| Other Study ID Numbers: | NMCP.2009.0062 |
| Study First Received: | February 25, 2010 |
| Last Updated: | September 29, 2010 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by United States Naval Medical Center, Portsmouth:
|
Long-Acting Reversible Contraception Contraceptive Agents Therapeutic Uses Contraceptive Agents, Female |
Reproductive Control Agents Pharmacologic Actions Levonorgestrel |
Additional relevant MeSH terms:
|
Contraceptive Agents Levonorgestrel Contraceptive Agents, Female Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 23, 2013