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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Contraception
• Intervention / Treatment: Device: Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Portsmouth, Virginia, United States, 23507
      • Naval Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuation Rates of the LNG-IUS when placed postpartum at three time periods	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).	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expulsion rate of the LNG-IUS when placed postpartum at three time periods	Determine if there is a difference in expulsion rates at the three different time periods of placement.	at 3 weeks
Pain at placement	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.	at 1 minute

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, Portsmouth

Publications and helpful links

General Publications

• Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimated): March 17, 2010

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacologic Actions; Therapeutic Uses; Levonorgestrel; Reproductive Control Agents; Contraceptive Agents; Long-Acting Reversible Contraception; Contraceptive Agents, Female
• Additional Relevant MeSH Terms: Contraceptive Agents, Hormonal; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: NMCP.2009.0062