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

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02341027
• Other study ID #: SFP2016
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraceptive Implant Utilization
• Lactation

Intervention

Device:
• Jadelle
within 5 days of delivery and before discharge from hospital
• Jadelle
6-8 weeks (42-56 days) postpartum

Locations

Country	Name	City	State
Uganda	Mulago Hospital	Kampala

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Makerere University, Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Breastfeeding continuation rates as measured by self-report over the initial 6 months.		6 months
Secondary	Time to lactogenesis measured by self-reported onset of lactogenesis.		72 hours
Secondary	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
Secondary	Pregnancy		6 months