Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02341027|
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Contraceptive Implant Utilization Lactation||Device: Jadelle||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Active Comparator: Levonorgestrel (LNG) implants immediately postpartum
LNG contraceptive implants provided within 5 days of delivery
within 5 days of delivery and before discharge from hospital
Active Comparator: Levonorgestrel (LNG) implants 6 weeks postpartum
LNG contraceptive implants provided 6-8 weeks postpartum
6-8 weeks (42-56 days) postpartum
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341027
|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|