NCT01161095

Brief Summary

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2014

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3.9 years

First QC Date

July 12, 2010

Last Update Submit

July 16, 2025

Conditions

ContraceptionPostpartum Period

Keywords

Intrauterine DevicePostpartum contraceptionLong-acting reversible contraception

Outcome Measures

Primary Outcomes (1)

  • Continuation Rates

    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 Outcomes (8)

  • Pain at insertion

    1 minute

  • Postpartum Depression

    6 months

  • Breastfeeding Status

    6 months

  • Postpartum weight retention

    6 months

  • Sexual Function

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Immediate

EXPERIMENTAL

LNG-IUS insertion within the timeframe of delivery of the placenta to 72 hours postpartum

Device: LNG-IUS

Interval

ACTIVE COMPARATOR

LNG-IUS insertion after 6 weeks postpartum

Device: LNG-IUS

Interventions

LNG-IUSDEVICE

Mirena (Bayer)- Levonorgestrel-Intrauterine System

ImmediateInterval

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for the Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Naval Medical Center

Portsmouth, Virginia, 23507, United States

Location
0

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

July 12, 2010

First Posted

July 13, 2010

Study Start

July 1, 2010

Primary Completion

May 28, 2014

Study Completion

May 28, 2014

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations

US(2)