Clinical trial NCT02341027: Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Official title: Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Implant Utilization
Lactation
Keywords: Immediate postpartum contraception
Contraceptive implants
Breastfeeding
Jadelle
Lactation
Levonorgestrel
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mulago Hospital, Uganda
name: Makerere University
First posted: 2015-01-19
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: Breastfeeding continuation rates as measured by self-report over the initial 6 months.
timeFrame: 6 months
measure: Time to lactogenesis measured by self-reported onset of lactogenesis.
timeFrame: 72 hours
measure: Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months.
timeFrame: Birth to 6 months
measure: Pregnancy
timeFrame: 6 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Hospital
Study officials:
affiliation: University of California, San Francisco
name: Sarah Averbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Jody Steinauer, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Mulago Hospital and Makerere University College of Health Sciences
name: Josephat Byamugisha, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.