NCT01990703

Brief Summary

We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
5 months until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

November 15, 2013

Results QC Date

March 27, 2017

Last Update Submit

May 16, 2017

Conditions

Contraception

Keywords

ContraceptionBirth ControlLevonorgestrel IUDMirena IUD

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Continuation Rates at 8 Weeks Postpartum

    To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.

    8 weeks postpartum

Secondary Outcomes (1)

  • Time to Lactogenesis Stage 2

    First 5 days after birth

Study Arms (2)

Early IUD Insertion Group

EXPERIMENTAL

Immediate post-placental placement of the levonorgestrel IUD

Drug: Levonorgestrel IUD

Standard Postpartum Insertion Group

ACTIVE COMPARATOR

Placement of the levonorgestrel IUD 4-6 weeks postpartum

Drug: Levonorgestrel IUD

Interventions

Levonorgestrel IUDDRUG

Timing of IUD insertion

Also known as: Mirena
Early IUD Insertion GroupStandard Postpartum Insertion Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, 18-40 year old pregnant women
  • Intend to breastfeed
  • Desire the LNG IUD as their method of contraception
  • Agree to be randomized to early versus standard postpartum insertion
  • Have delivered a healthy term infant (37 weeks gestation)
  • Willing to complete all study related procedures, visits and questionnaires

You may not qualify if:

  • Chorioamnionitis
  • Obstetric complications including transfusion
  • Severe pregnancy induced hypertension
  • Prolonged hospitalization
  • Coagulopathy
  • Liver disease
  • Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Hopelian NG, Simmons RG, Sanders JN, Ward K, Jenkins SM, Espey E, Turok DK. Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD. BMC Womens Health. 2021 Jan 21;21(1):33. doi: 10.1186/s12905-021-01179-7.

    PMID: 33478494DERIVED

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Limitations and Caveats

Inability to blind, loss to follow-up, and lack of long-term infant and childhood outcomes. We had a smaller final sample than intended despite meeting enrollment goals.

Results Point of Contact

Title
Dr. David Turok
Organization
University of Utah, Department of OBGYN
david.turok@hsc.utah.edu
801-581-6170

Study Officials

  • David K Turok, MD

    University of Utah Department of Obstetrics & Gynecology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

November 15, 2013

First Posted

November 21, 2013

Study Start

January 1, 2014

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

June 14, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)