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

NCT01088178 | Withdrawn DMC

• 1 other identifier: NMCP.2009.0062
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contraception

Keywords

Long-Acting Reversible Contraception; Contraceptive Agents; Therapeutic Uses; Contraceptive Agents, Female; Reproductive Control Agents; Pharmacologic Actions; Levonorgestrel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  at 3 weeks

• Pain at placement

  at 1 minute

Study Arms (3)

Immediate Postplacental

EXPERIMENTAL

Within 10 minutes from delivery of placenta

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

Early Postpartum

EXPERIMENTAL

After 10 minutes from delivery of placenta but within 48hrs from delivery

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

Interval

EXPERIMENTAL

After 6 weeks postpartum

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

Interventions

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

Placement of Mirena at given intervals during the postpartum period

Early Postpartum; Immediate Postplacental; Interval

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, Portsmouth: lead

Study Sites (1)

Naval Medical Center

Portsmouth, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 21843688 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 17, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)