NCT02341027

Brief Summary

This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG) contraceptive implant within 5 days of delivery improves implant utilization at 6 months postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

January 9, 2015

Last Update Submit

February 11, 2020

Conditions

Contraceptive Implant UtilizationLactation

Keywords

Immediate postpartum contraceptionContraceptive implantsBreastfeedingJadelleLactationLevonorgestrel

Outcome Measures

Primary Outcomes (1)

  • Implant utilization as measured by the proportion of women using LNG contraceptive implants at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6-8 weeks after delivery (delayed insertion).

    6 months

Secondary Outcomes (4)

  • Breastfeeding continuation rates as measured by self-report over the initial 6 months.

    6 months

  • Time to lactogenesis measured by self-reported onset of lactogenesis.

    72 hours

  • Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months.

    Birth to 6 months

  • Pregnancy

    6 months

Study Arms (2)

Levonorgestrel (LNG) implants immediately postpartum

ACTIVE COMPARATOR

LNG contraceptive implants provided within 5 days of delivery

Device: Jadelle

Levonorgestrel (LNG) implants 6 weeks postpartum

ACTIVE COMPARATOR

LNG contraceptive implants provided 6-8 weeks postpartum

Device: Jadelle

Interventions

JadelleDEVICE

within 5 days of delivery and before discharge from hospital

Also known as: Levonorgestrel contraceptive implants, Sino-Implant
Levonorgestrel (LNG) implants immediately postpartum

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • years old
  • Voluntarily requesting contraceptive implants for postpartum contraception
  • Vaginal delivery or cesarean delivery at Mulago Hospital
  • Willing and able to give informed consent
  • Agree to a possible home visit for follow up
  • Access to a cellphone for the duration of the study

You may not qualify if:

  • Current breast cancer or breast cancer within the past 5 years
  • Decompensated cirrhosis or a liver tumor
  • Unexplained vaginal bleeding prior to pregnancy
  • Current (or planned) use of Efavirenz medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

  • Averbach S, Kakaire O, Kayiga H, Lester F, Sokoloff A, Byamugisha J, Dehlendorf C, Steinauer J. Immediate versus delayed postpartum use of levonorgestrel contraceptive implants: a randomized controlled trial in Uganda. Am J Obstet Gynecol. 2017 Nov;217(5):568.e1-568.e7. doi: 10.1016/j.ajog.2017.06.005. Epub 2017 Jun 10.

    PMID: 28610898DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Sarah Averbach, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Jody Steinauer, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Josephat Byamugisha, MBChB, PhD

    Mulago Hospital and Makerere University College of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

UG(1)