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Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period

Information source: United States Naval Medical Center, Portsmouth
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Contraception

Intervention: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: United States Naval Medical Center, Portsmouth

Overall contact:
Joshua D Dahlke, MD, Phone: 757-953-4503, Email: joshua.dahlke@med.navy.mil

Summary

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.

Clinical Details

Official title: Levonorgestrel-Intrauterine System (LNG-IUS) Insertion in the Postpartum Period: A Prospective, Randomized Pilot Study of Three Time Intervals

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Continuation Rates of the LNG-IUS when placed postpartum at three time periods

Secondary outcome:

Expulsion rate of the LNG-IUS when placed postpartum at three time periods

Pain at placement

Eligibility

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Joshua D Dahlke, MD, Phone: 757-953-4503, Email: joshua.dahlke@med.navy.mil

Naval Medical Center, Portsmouth, Virginia 23507, United States; Recruiting
Joshua D Dahlke, MD, Email: joshua.dahlke@med.navy.mil
Joshua D Dahlke, MD, Principal Investigator
Additional Information

Starting date: November 2009
Last updated: September 29, 2010

Page last updated: August 23, 2015

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