Contraceptive Implant UtilizationNCT02341027
Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
A study testing Jadelle in people with Contraceptive Implant Utilization and Lactation, run by University of California, San Francisco at 1 site in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Contraceptive Implant Utilization, Lactation
- What is being tested?
- Jadelle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUganda
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Contraceptive Implant Utilization, Lactation
- Being tested
- Jadelle
- Keywords
- Immediate postpartum contraception, Contraceptive implants, Breastfeeding, Jadelle, Lactation, Levonorgestrel
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JadelleDevice
Also called Levonorgestrel contraceptive implants, Sino-Implant
within 5 days of delivery and before discharge from hospital
JadelleDevice
Also called Levonorgestrel contraceptive implants, Sino-Implant
6-8 weeks (42-56 days) postpartum
| Study group | Role | What they receive |
|---|---|---|
| Levonorgestrel (LNG) implants immediately postpartum | Active comparator | LNG contraceptive implants provided within 5 days of delivery Receives: Device: Jadelle |
| Levonorgestrel (LNG) implants 6 weeks postpartum | Active comparator | LNG contraceptive implants provided 6-8 weeks postpartum Receives: Device: Jadelle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (4)
Breastfeeding continuation rates as measured by self-report over the initial 6 months.
Measured: 6 months
Time to lactogenesis measured by self-reported onset of lactogenesis.
Measured: 72 hours
Change in percentile in infant weight, length and head circumference from delivery to 6 weeks and from delivery to 6 months.
Measured: Birth to 6 months
Pregnancy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contraceptive Implant UtilizationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Mulago Hospital, Uganda, Makerere University
- Responsible party
- Sponsor
- Investigators
- Sarah Averbach, MD, Principal investigator, University of California, San FranciscoJody Steinauer, MD, MAS, Principal investigator, University of California, San FranciscoJosephat Byamugisha, MBChB, PhD, Principal investigator, Mulago Hospital and Makerere University College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341027
- Sponsor's protocol ID
- SFP2016
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28610898
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02341027
- Acronym / sponsor ID
- SFP2016
- Conditions
- Contraceptive Implant Utilization, Lactation
- Keywords
- Immediate postpartum contraception, Contraceptive implants, Breastfeeding, Jadelle, Lactation, Levonorgestrel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Mulago Hospital, Uganda, Makerere University
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levonorgestrel (LNG) implants immediately postpartum | Active comparator | Device: JadelleLNG contraceptive implants provided within 5 days of delivery |
| Levonorgestrel (LNG) implants 6 weeks postpartum | Active comparator | Device: JadelleLNG contraceptive implants provided 6-8 weeks postpartum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JadelleAlso: Levonorgestrel contraceptive implants, Sino-Implantwithin 5 days of delivery and before discharge from hospital | Device | Levonorgestrel (LNG) implants immediately postpartum |
| JadelleAlso: Levonorgestrel contraceptive implants, Sino-Implant6-8 weeks (42-56 days) postpartum | Device | Levonorgestrel (LNG) implants 6 weeks postpartum |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Derived from this study: PubMed 28610898Averbach 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.
Related trials for Contraceptive Implant Utilization
Recruiting
Structured Contraceptive Counseling During Pregnancy
Contraception, Intrauterine Device
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Averbach, MD principal investigator
University of California, San Francisco
Jody Steinauer, MD, MAS principal investigator
University of California, San Francisco
Josephat Byamugisha, MBChB, PhD principal investigator
Mulago Hospital and Makerere University College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jadelle in people with Contraceptive Implant Utilization and Lactation, run by University of California, San Francisco at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.