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Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents (Implanon)

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ClinicalTrials.gov Identifier: NCT03585504
Recruitment Status : Completed
First Posted : July 13, 2018
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
American College of Obstetricians and Gynecologists
Bayer
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The specific aim of this study is to evaluate whether insertion of a long-acting contraceptive implant in postpartum adolescents prior to hospital discharge increases use of this highly effective contraception during the first twelve months postpartum among adolescents who elect Implanon® as their preferred method of contraception. Additionally, this study aims to compare the acceptability of bleeding in postpartum adolescents who have an etonogestrel contraceptive implant prior to discharge versus those with insertion at the six week postpartum visit. The investigators will evaluate the acceptability of bleeding rather than collect prospective diaries because the investigators feel subjective perceptions of bleeding impact contraceptive continuation more than quantitative differences in bleeding.

Condition or disease Intervention/treatment Phase
Contraceptive Usage Drug: Etonogestrel contraceptive implant Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants were randomized to receive a contraceptive implant before hospital discharge or at their six week postpartum visit
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Intervention group
Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.
Drug: Etonogestrel contraceptive implant
Etonogestrel contraceptive implant

Active Comparator: Control Group
These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.
Drug: Etonogestrel contraceptive implant
Etonogestrel contraceptive implant




Primary Outcome Measures :
  1. Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum [ Time Frame: 6 months ]
    We compare the number of participants continuing the implant at six months in each group.


Secondary Outcome Measures :
  1. Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum. [ Time Frame: 6 months ]
    Compare the number of participants who reported that they were somewhat or very satisfied with their subjective bleeding experience at six months postpartum in each group. Each participant was asked, "Please indicate your overall level of satisfaction with your bleeding." The response options were "very satisfied", "somewhat satisfied", "somewhat dissatisfied", and "very dissatisfied". The outcome measure was treated as a categorical variable.

  2. Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum. [ Time Frame: 6 months ]
    Comparison of the number of participants in each group who report that they were somewhat or very satisfied with their contraceptive method choice at six months postpartum in each group. Participants were asked, " How would you rate your overall satisfaction with implanon?" The response options were "very satisfied", "somewhat satisfied", "somewhat dissatisfied", and "very dissatisfied". The outcome measure was treated as a categorical variable.



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Ages Eligible for Study:   15 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ages 15-21
  • women
  • english or spanish speaking
  • less than 120 hours post partum

Exclusion Criteria:

  • women who are breastfeeding
  • contraindications to Implanon® insertion including current or prior thrombo-embolic disease, liver disease, hypersensitivity to components of Implanon®, or are using medications such as rifampin, phenytoin, or carbamazepine that increase metabolism of steroid hormones.
  • indicate unwillingness to continue follow-up for one year.

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): NCT03585504


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
American College of Obstetricians and Gynecologists
Bayer
Investigators
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Principal Investigator: Angela Dempsey, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03585504     History of Changes
Other Study ID Numbers: HR #19133
First Posted: July 13, 2018    Key Record Dates
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of South Carolina:
Implanon
Bleeding Acceptability
Contraceptive Implant
Adolescent Pregnancy Prevention
Post Partum Insertion of Implanon

Additional relevant MeSH terms:
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Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists