Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341027
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Mulago Hospital, Uganda
Makerere University
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 9, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date February 17, 2020
Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
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). [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2015)
  • Breastfeeding continuation rates as measured by self-report over the initial 6 months. [ Time Frame: 6 months ]
  • Time to lactogenesis measured by self-reported onset of lactogenesis. [ Time Frame: 72 hours ]
  • Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months. [ Time Frame: Birth to 6 months ]
  • Pregnancy [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Official Title  ICMJE Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
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.
Detailed Description

Waiting until 6 weeks postpartum to initiate contraception puts women at risk for unintended pregnancy and short birth intervals. Short birth intervals of less than 18 months are associated with an increased risk of preterm delivery and low birth weight infants.

Subdermal implants are advantageous for the postpartum period because they are long-acting, reversible, and highly effective, and they do not contain estrogen or require intrauterine placement. In observational studies postpartum continuation rates have been shown to be greater than 95% after 6 months and 86-87% after 1 year in US populations. Implants are not routinely available during the immediate postpartum period in Uganda, and availability could improve the contraceptive method mix for postpartum women in that country. The results of this study may support increasing access to a form of immediate postpartum LARC (long acting reversible contraception) in a developing country.

This is a randomized, controlled trial of the association between immediate postpartum contraceptive implant placement and implant utilization at 6 months postpartum among women in Uganda. This study will compare the proportion of women using the Levonorgestrel contraceptive implant at 6 months after delivery in women randomized to insertion within 5 days of delivery (immediate insertion) or 6 weeks after delivery (delayed insertion). The study population is women who have a delivery at Mulago hospital in Kampala, Uganda and choose a contraceptive implant for postpartum contraception.

The investigators plan to enroll 202 women who are planning to receive a postpartum Levonorgestrel contraceptive implant after delivery to find out whether the timing of postpartum administration of the implant (prior to hospital discharge or 6 weeks after delivery) affects implant utilization, satisfaction with the implant, vaginal bleeding or breastfeeding.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Contraceptive Implant Utilization
  • Lactation
Intervention  ICMJE
  • Device: Jadelle
    within 5 days of delivery and before discharge from hospital
    Other Names:
    • Levonorgestrel contraceptive implants
    • Sino-Implant
  • Device: Jadelle
    6-8 weeks (42-56 days) postpartum
    Other Names:
    • Levonorgestrel contraceptive implants
    • Sino-Implant
Study Arms  ICMJE
  • Active Comparator: Levonorgestrel (LNG) implants immediately postpartum
    LNG contraceptive implants provided within 5 days of delivery
    Intervention: Device: Jadelle
  • Active Comparator: Levonorgestrel (LNG) implants 6 weeks postpartum
    LNG contraceptive implants provided 6-8 weeks postpartum
    Intervention: Device: Jadelle
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2016)
205
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2015)
202
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female
  • 18 - 50 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02341027
Other Study ID Numbers  ICMJE SFP2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Mulago Hospital, Uganda
  • Makerere University
Investigators  ICMJE
Principal Investigator: 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
PRS Account University of California, San Francisco
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP