NCT00635362

Brief Summary

The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery. Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

May 13, 2013

Completed
Last Updated

March 22, 2023

Status Verified

February 1, 2023

Enrollment Period

3.7 years

First QC Date

March 5, 2008

Results QC Date

February 22, 2013

Last Update Submit

February 21, 2023

Conditions

Healthy

Keywords

ContraceptionContraceptive DevicesIntrauterine DevicesUnplanned PregnancyPostpartum Period

Outcome Measures

Primary Outcomes (1)

  • Use of the LNG-IUS for Contraception

    12 months after cesarean delivery

Secondary Outcomes (4)

  • Rates of Expulsion of the LNG-IUS

    12 months after cesarean delivery

  • Perforation Rates

    12 months after cesarean delivery

  • Satisfaction With LNG-IUS

    6 months after cesarean delivery

  • Satisfaction With LNG-IUS

    12 months after cesarean delivery

Study Arms (2)

postplacental insertion after cesarean

EXPERIMENTAL

Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

delayed insertion group

ACTIVE COMPARATOR

Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)

Interventions

Levonorgestrel-releasing intrauterine system (LNG-IUS)DEVICE

Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta

Also known as: Mirena IUD
postplacental insertion after cesarean

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant at time of enrollment
  • Planning to undergo a scheduled cesarean delivery
  • Desires to use the LNG-IUS for contraception
  • Willing and able to sign an informed consent in English
  • Willing to comply with the study protocol
  • Age greater than or equal to 18 years
  • English speaking

You may not qualify if:

  • Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS
  • Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result
  • Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS
  • Uterine anomaly which would not allow placement of the LNG-IUS
  • Current cervical cancer or carcinoma in-situ
  • Desire for repeat pregnancy in less than 12 months
  • History of postabortal or postpartum sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Whitaker AK, Endres LK, Mistretta SQ, Gilliam ML. Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial. Contraception. 2014 Jun;89(6):534-9. doi: 10.1016/j.contraception.2013.12.007. Epub 2013 Dec 26.

    PMID: 24457061DERIVED

Results Point of Contact

Title
Amy Whitaker, MD
Organization
University of Chicago
awhitaker@babies.bsd.uchicago.edu
773-834-4129

Study Officials

  • Melissa Gilliam, MD MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2008

First Posted

March 13, 2008

Study Start

May 1, 2007

Primary Completion

January 1, 2011

Study Completion

February 1, 2013

Last Updated

March 22, 2023

Results First Posted

May 13, 2013

Record last verified: 2023-02

Locations

US(1)