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Trial record 18 of 404 for:    LEVONORGESTREL

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

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ClinicalTrials.gov Identifier: NCT02341027
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : July 18, 2016
Sponsor:
Collaborators:
Mulago Hospital, Uganda
Makerere University
Information provided by (Responsible Party):
Jody Steinauer, MD, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Contraceptive Implant Utilization Lactation Device: Jadelle Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Active Comparator: Levonorgestrel (LNG) implants immediately postpartum
LNG contraceptive implants provided within 5 days of delivery
Device: Jadelle
within 5 days of delivery and before discharge from hospital
Other Names:
  • Levonorgestrel contraceptive implants
  • Sino-Implant

Active Comparator: Levonorgestrel (LNG) implants 6 weeks postpartum
LNG contraceptive implants provided 6-8 weeks postpartum
Device: Jadelle
6-8 weeks (42-56 days) postpartum
Other Names:
  • Levonorgestrel contraceptive implants
  • Sino-Implant




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Breastfeeding continuation rates as measured by self-report over the initial 6 months. [ Time Frame: 6 months ]
  2. Time to lactogenesis measured by self-reported onset of lactogenesis. [ Time Frame: 72 hours ]
  3. 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 ]
  4. Pregnancy [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341027


Locations
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Uganda
Mulago Hospital
Kampala, Uganda
Sponsors and Collaborators
University of California, San Francisco
Mulago Hospital, Uganda
Makerere University
Investigators
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Principal Investigator: Sarah Averbach, MD University of California, San Francisco
Principal Investigator: Jody Steinauer, MD, MAS University of California, San Francisco
Principal Investigator: Josephat Byamugisha, MBChB, PhD Mulago Hospital and Makerere University College of Health Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jody Steinauer, MD, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02341027     History of Changes
Other Study ID Numbers: SFP2016
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016
Keywords provided by Jody Steinauer, MD, University of California, San Francisco:
Immediate postpartum contraception
Contraceptive implants
Breastfeeding
Jadelle
Lactation
Levonorgestrel
Additional relevant MeSH terms:
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Contraceptive Agents
Levonorgestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral