Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03585504
Status:
COMPLETED
Last Update Posted:
2018-10-04
First Post:
2018-05-10
Brief Title:
Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Randomized Controlled Trial of Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Implanon
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
Detailed Description:
Study Design and Subject Recruitment The investigators propose a prospective randomized trial comparing immediate postpartum insertion of Implanon versus insertion at the standard six week postpartum visit in adolescents Recruitment will occur on our postpartum ward
The study coordinator will approach all eligible women on the postpartum ward to offer comprehensive contraceptive counseling including information about Implanon as well as other methods Those who choose Implanon will be screened for eligibility and consented for participation in the study If a subject is under 18 years of age the investigators will obtain parental consent from at least one parent or legal guardian as well as assent from the adolescent participant according to our IRB guidelines Those who are not interested in participation will be provided with a standard postpartum appointment for insertion Based on our volume of adolescent deliveries the investigators anticipate to complete enrollment within 1 year and follow-up within two years
Inclusion and Exclusion Criteria Women will be eligible for enrollment if they are 21 years old or younger English or Spanish speaking less than 120 hours 5 days postpartum after either vaginal or cesarean delivery primiparous or multiparous and breast andor bottle-feeding Women will be excluded from enrollment if they have 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 Women will also be excluded if they indicate unwillingness to continue follow-up for one year
Randomization After consent is obtained each participant will be randomized to one of two groups The study coordinator will open opaque sealed envelopes containing group assignment in sequence The envelopes will be prepared by a research staff member not involved in recruitment or analysis prior to start of enrollment The randomization scheme will utilize permuted blocks of sizes four and six The intervention group will undergo Implanon insertion prior to hospital discharge per package instructions For those randomized to this group the study coordinator will notify the physician on call to ensure insertion prior to discharge This will not prolong hospital stay The control group will receive an appointment to undergo Implanon insertion at the postpartum visit occurring approximately six weeks after delivery as is standard care in our institution In addition to standard counseling to avoid sexual intercourse for six weeks all participants will be counseled about condom use for prevention of both sexually transmitted infections and pregnancy
Follow-up At the time of enrollment each participant will complete a questionnaire to collect information about sociodemographic characteristics sexual and reproductive history contraceptive history bleeding expectations breast feeding intentions and prior sexual education experiences Each participant will be provided with a notice of study participation to give their provider at their postpartum follow-up visit but there will not be contact between study staff and participants at the six week postpartum visit Each participant will be contacted by telephone at three six and twelve months postpartum Follow-up questionnaires will be administered at this time to assess use of Implanon since delivery use of other highly effective and less effective contraceptive methods the acceptability of bleeding experiences and the prevalence and duration of breastfeeding
Outcomes
Primary Outcome is the proportion of participants in each group using Implanon at six months
Secondary Outcomes Contraceptive Use and Pregnancy
Proportion of participants using Implanon at three months
Proportion of participants using Implanon at twelve months
Proportion of participants using another highly effective method at three six and twelve months
Intrauterine contraception and sterilization will be considered highly effective in this study
Proportion of participants using a less effective method at three six and twelve months DMPA combined hormonal oral contraception vaginal ring transdermal patch progestin only pills and barrier methods will be considered less effective methods in this study
Proportion of participants practicing abstinence at three six and twelve months
Proportion of participants using no contraceptive method at three six and twelve months
Reasons for non-use of Implanon at three six and twelve months
Reasons for non-use of any method at three six and twelve months
Pregnancy rate in each group at twelve months
o Bleeding Acceptability
Bleeding expectations prior to insertion of Implanon
Comparison of bleeding perceptions to pre-insertion expectations
Proportion of participants who cite bleeding irregularities as a reason for non-use at three six and twelve months
Satisfaction with bleeding on Likert scale
o Overall Acceptability 5 of 12
Proportion at three six and twelve months willing to use Implanon again after another delivery
Proportion at three six and twelve months willing to recommend Implanon to a friend
o Breast Feeding
Proportion of participants in each group planning to breastfeed at time of enrollment
Proportion of participants breast feeding at three six and twelve months
Duration of breast feeding in weeks by participant report
The study coordinator will approach all eligible women on the postpartum ward to offer comprehensive contraceptive counseling including information about Implanon as well as other methods Those who choose Implanon will be screened for eligibility and consented for participation in the study If a subject is under 18 years of age the investigators will obtain parental consent from at least one parent or legal guardian as well as assent from the adolescent participant according to our IRB guidelines Those who are not interested in participation will be provided with a standard postpartum appointment for insertion Based on our volume of adolescent deliveries the investigators anticipate to complete enrollment within 1 year and follow-up within two years
Inclusion and Exclusion Criteria Women will be eligible for enrollment if they are 21 years old or younger English or Spanish speaking less than 120 hours 5 days postpartum after either vaginal or cesarean delivery primiparous or multiparous and breast andor bottle-feeding Women will be excluded from enrollment if they have 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 Women will also be excluded if they indicate unwillingness to continue follow-up for one year
Randomization After consent is obtained each participant will be randomized to one of two groups The study coordinator will open opaque sealed envelopes containing group assignment in sequence The envelopes will be prepared by a research staff member not involved in recruitment or analysis prior to start of enrollment The randomization scheme will utilize permuted blocks of sizes four and six The intervention group will undergo Implanon insertion prior to hospital discharge per package instructions For those randomized to this group the study coordinator will notify the physician on call to ensure insertion prior to discharge This will not prolong hospital stay The control group will receive an appointment to undergo Implanon insertion at the postpartum visit occurring approximately six weeks after delivery as is standard care in our institution In addition to standard counseling to avoid sexual intercourse for six weeks all participants will be counseled about condom use for prevention of both sexually transmitted infections and pregnancy
Follow-up At the time of enrollment each participant will complete a questionnaire to collect information about sociodemographic characteristics sexual and reproductive history contraceptive history bleeding expectations breast feeding intentions and prior sexual education experiences Each participant will be provided with a notice of study participation to give their provider at their postpartum follow-up visit but there will not be contact between study staff and participants at the six week postpartum visit Each participant will be contacted by telephone at three six and twelve months postpartum Follow-up questionnaires will be administered at this time to assess use of Implanon since delivery use of other highly effective and less effective contraceptive methods the acceptability of bleeding experiences and the prevalence and duration of breastfeeding
Outcomes
Primary Outcome is the proportion of participants in each group using Implanon at six months
Secondary Outcomes Contraceptive Use and Pregnancy
Proportion of participants using Implanon at three months
Proportion of participants using Implanon at twelve months
Proportion of participants using another highly effective method at three six and twelve months
Intrauterine contraception and sterilization will be considered highly effective in this study
Proportion of participants using a less effective method at three six and twelve months DMPA combined hormonal oral contraception vaginal ring transdermal patch progestin only pills and barrier methods will be considered less effective methods in this study
Proportion of participants practicing abstinence at three six and twelve months
Proportion of participants using no contraceptive method at three six and twelve months
Reasons for non-use of Implanon at three six and twelve months
Reasons for non-use of any method at three six and twelve months
Pregnancy rate in each group at twelve months
o Bleeding Acceptability
Bleeding expectations prior to insertion of Implanon
Comparison of bleeding perceptions to pre-insertion expectations
Proportion of participants who cite bleeding irregularities as a reason for non-use at three six and twelve months
Satisfaction with bleeding on Likert scale
o Overall Acceptability 5 of 12
Proportion at three six and twelve months willing to use Implanon again after another delivery
Proportion at three six and twelve months willing to recommend Implanon to a friend
o Breast Feeding
Proportion of participants in each group planning to breastfeed at time of enrollment
Proportion of participants breast feeding at three six and twelve months
Duration of breast feeding in weeks by participant report
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None