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

University of California San Francisco (UCSF)

Status: Completed

Conditions: Contraceptive Implant Utilization; Lactation

Treatments: Device: Jadelle

Study type: Interventional

Funder types: Other

Identifiers

NCT02341027

SFP2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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205 participants in 2 patient groups

Levonorgestrel (LNG) implants immediately postpartum

Active Comparator group

Description:

LNG contraceptive implants provided within 5 days of delivery

Treatment:

Device: Jadelle

Device: Jadelle

Levonorgestrel (LNG) implants 6 weeks postpartum

Active Comparator group

Description:

LNG contraceptive implants provided 6-8 weeks postpartum

Treatment:

Device: Jadelle

Device: Jadelle