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

February 11, 2020 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

205

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Mulago Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levonorgestrel (LNG) implants immediately postpartum
LNG contraceptive implants provided within 5 days of delivery
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
Active Comparator: Levonorgestrel (LNG) implants 6 weeks postpartum
LNG contraceptive implants provided 6-8 weeks postpartum
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Breastfeeding continuation rates as measured by self-report over the initial 6 months.
Time Frame: 6 months
6 months
Time to lactogenesis measured by self-reported onset of lactogenesis.
Time Frame: 72 hours
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
Birth to 6 months
Pregnancy
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Makerere University
Mulago Hospital, Uganda

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

January 9, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFP2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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