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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Contraceptive Usage
Intervention Drug: Etonogestrel contraceptive implant
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

Period Title: Overall Study
Started 41 40
Completed 15 11
Not Completed 26 29
Reason Not Completed
Lost to Follow-up             26             29
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 11 participants 26 participants
18.93  (1.64) 19.64  (1.03) 19.24  (1.42)
[1]
Measure Analysis Population Description: Age was not recorded in the baseline questionnaire.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
41
 100.0%
40
 100.0%
81
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.4%
0
   0.0%
1
   1.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   2.5%
1
   1.2%
Black or African American
30
  73.2%
31
  77.5%
61
  75.3%
White
8
  19.5%
7
  17.5%
15
  18.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   4.9%
1
   2.5%
3
   3.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 40 participants 81 participants
41 40 81
1.Primary Outcome
Title Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum
Hide Description We compare the number of participants continuing the implant at six months in each group.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

Overall Number of Participants Analyzed 15 11
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
7
  63.6%
2.Secondary Outcome
Title Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

Overall Number of Participants Analyzed 15 11
Measure Type: Count of Participants
Unit of Measure: Participants
10
  66.7%
8
  72.7%
3.Secondary Outcome
Title Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

Overall Number of Participants Analyzed 15 11
Measure Type: Count of Participants
Unit of Measure: Participants
14
  93.3%
6
  54.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

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.

Etonogestrel contraceptive implant: Etonogestrel contraceptive implant

All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/11 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Angela Dempsey
Organization: Medical University of South Carolina
Phone: 843-762-4500
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03585504     History of Changes
Other Study ID Numbers: HR #19133
First Submitted: May 10, 2018
First Posted: July 13, 2018
Results First Submitted: August 24, 2018
Results First Posted: October 4, 2018
Last Update Posted: October 4, 2018