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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraceptive Implant Utilization, Lactation

Intervention / Treatment
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* Device: Jadelle
* Device: Jadelle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levonorgestrel (LNG) implants immediately postpartum<br>LNG contraceptive implants provided within 5 days of delivery | Device: Jadelle<br>* within 5 days of delivery and before discharge from hospital<br>* Other names: Sino-Implant;|
| Active Comparator: Levonorgestrel (LNG) implants 6 weeks postpartum<br>LNG contraceptive implants provided 6-8 weeks postpartum | Device: Jadelle<br>* 6-8 weeks (42-56 days) postpartum<br>* Other names: Sino-Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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). |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immediate postpartum contraception, Contraceptive implants, Breastfeeding, Jadelle, Lactation, Levonorgestrel