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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

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.

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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.

Conditions

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Contraceptive Implant Utilization Lactation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Levonorgestrel (LNG) implants immediately postpartum

LNG contraceptive implants provided within 5 days of delivery

Group Type ACTIVE_COMPARATOR

Jadelle

Intervention Type DEVICE

within 5 days of delivery and before discharge from hospital

Levonorgestrel (LNG) implants 6 weeks postpartum

LNG contraceptive implants provided 6-8 weeks postpartum

Group Type ACTIVE_COMPARATOR

Jadelle

Intervention Type DEVICE

6-8 weeks (42-56 days) postpartum

Interventions

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Jadelle

within 5 days of delivery and before discharge from hospital

Intervention Type DEVICE

Jadelle

6-8 weeks (42-56 days) postpartum

Intervention Type DEVICE

Other Intervention Names

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Levonorgestrel contraceptive implants Sino-Implant Levonorgestrel contraceptive implants Sino-Implant

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No