Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Condition: Contraceptive Implant Utilization; Lactation
Study type: Interventional

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.
    

Intervention name(s): Jadelle; Jadelle
Intervention type(s): Device; Device
Intervention description(s): within 5 days of delivery and before discharge from hospital; 6-8 weeks (42-56 days) postpartum
Other intervention name(s): Levonorgestrel contraceptive implants; Sino-Implant; Levonorgestrel contraceptive implants; Sino-Implant
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immediate postpartum contraception; Contraceptive implants; Breastfeeding; Jadelle; Lactation; Levonorgestrel