Contraception
Conditions
Brief summary
The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.
Detailed description
Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO). The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood. Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups. Primary: Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups. Aim #2: To determine the timing of lactogenesis in both groups Secondary: Aim #1: To assess breastfeeding continuation and exclusivity between the immediate versus the standard group. Aim #2: To compare postpartum factors associated with discontinuing breastfeeding between the immediate versus the standard group. Aim #3: To compare participant satisfaction with postpartum contraception counseling in women enrolled in the study and in those women who opted not to enroll in the study between the immediate versus the standard group. Aim #4: To compare postpartum mood as measured by EPDS score between the immediate versus the standard group. Aim #5: To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score between the immediate versus the standard group. Aim #6: To compare the total number of days of postpartum bleeding in the immediate versus standard. Aim #7: To compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate insertion (first 24 hours after delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the ENG implant.
Interventions
DRUGEtonogestrel
Immediate v. Standard insertion.
DEVICENexplanon
Implant.
Sponsors
University of New Mexico
Society of Family Planning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum) * Aged 13 and older * English or Spanish speakers * Deliver an infant at UNM Hospital at \> 37 weeks gestational age * Intend to breastfeed * Desire the implant as a method for contraception * Agree to randomization * Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)
Exclusion criteria
* Under age 13 * History of breast cancer (screen by past medical history) * History of undiagnosed vaginal bleeding (screen by past medical history) * Head trauma that affected pituitary function (screen by past medical history) * Prolactin insufficiency (screen by past medical history) * Previous lactation failure (defined as no lactation within 5 days postpartum) * Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history) * Liver dysfunction (screen by past medical history) * Use of drugs that inhibit lactation (screen by medical history) * Sensitivity to the components of the ENG implant (screen by past medical history) * Contraindications to use the implant by the (US MEC) (screen by past medical history) * Active labor * Delivery at \< 37 weeks gestational age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum | For the primary outcome will be the first eight weeks after delivery. | Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Factors Associated With Breastfeeding Discontinuation. | Up to 24 weeks postpartum. | Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group. Subjects were asked to rate the importance of seven different factors independently, on a 4-item Likert scale from 0 = Not at all important, to 3 = Very important |
| Satisfaction With Postpartum Contraception Counseling | At enrollment. | Person-Centered Contraceptive Counseling Measure (PCCC Measure) pcccmeasure.ucsf.edu Scale range: 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent Higher values represent higher satisfaction and patient-centeredness |
| Postpartum Mood | At 2, 4, and 8 weeks postpartum. | To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, and 8 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression. |
| Exclusive Breastfeeding | Up to 24 weeks postpartum. | Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement: If you are currently breastfeeding, are you: * Exclusively breastfeeding * Breastfeeding and supplementing breastfeeding with bottles of breast milk * Breastfeeding and supplementing breastfeeding with bottles of formula |
| Postpartum Bleeding Days | At 2, 4, and 8 weeks postpartum. | To compare the total number of days of postpartum bleeding in the immediate versus standard group. This is a secondary outcome for which analysis is ongoing. |
| Satisfaction With the ENG Implant | At 8 weeks postpartum | Using a questionnaire the investigators seek to compare participant satisfaction with the ENG implant between the immediate versus the standard group. Scale: 0= Unsatisfied, 1=Satisfied, 2=Very satisfied |
| Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups. | Up to 24 weeks postpartum | To compare timing of breastfeeding discontinuation through 6 months postpartum between the immediate versus the standard group. |
| Sexual Function | At 4, 8, and 12 weeks postpartum | To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above. For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Insertion Group, Per Protocol Immediate insertion within first 24 hours after delivery ENG implant insertion Intervention. | 62 |
| Standard Postpartum Insertion Group, Per Protocol Insertion of the Etonogestrel implant 4-6 weeks postpartum (changed post hoc to at least 2 weeks postpartum) | 53 |
| Total | 115 |
Baseline characteristics
| Characteristic | Immediate Insertion Group, Per Protocol | Standard Postpartum Insertion Group, Per Protocol | Total |
|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 5.5 | 27.2 years STANDARD_DEVIATION 5.3 | 27.7 years STANDARD_DEVIATION 5.4 |
| Delivery mode Cesarean | 9 Participants | 13 Participants | 22 Participants |
| Delivery mode Operative vaginal | 2 Participants | 1 Participants | 3 Participants |
| Delivery mode Vaginal | 51 Participants | 39 Participants | 90 Participants |
| Epidural | 43 Participants | 35 Participants | 78 Participants |
| Parity | 2 Parity | 1 Parity | 2 Parity |
| Planning to breastfeed more than 6 months | 51 Participants | 47 Participants | 98 Participants |
| Previously breastfed | 33 Participants | 23 Participants | 56 Participants |
| Previously used implant | 26 Participants | 16 Participants | 42 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 participants | 7 participants | 11 participants |
| Race/Ethnicity, Customized Black or African American | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Hispanic or Latina | 44 participants | 44 participants | 88 participants |
| Race/Ethnicity, Customized Other | 15 participants | 15 participants | 30 participants |
| Race/Ethnicity, Customized White | 34 participants | 26 participants | 60 participants |
| Recruitment site University of New Mexico | 50 Participants | 45 Participants | 95 Participants |
| Recruitment site University of Utah | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Female | 62 Participants | 53 Participants | 115 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 1 / 72 |
| other Total, other adverse events | 0 / 78 | 0 / 72 |
| serious Total, serious adverse events | 0 / 78 | 0 / 72 |
Outcome results
Primary
Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum
Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
Time frame: For the primary outcome will be the first eight weeks after delivery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum | 54 Participants |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum | 45 Participants |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Per Protocol | Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum | 48 Participants |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Per Protocol | Number of Participants With Continuation of Breastfeeding at 8 Weeks Postpartum | 43 Participants |
Comparison: To achieve 80% power with a 1-sided type 1 error of 5% utilizing the Z-test (unpooled), 62 participants would be required in each group, for a total of 124 participants. Accounting for expected loss to follow-up of 20%, we aimed to recruit 149 participants and rounded up to final recruitment goal of 150.
Secondary
Exclusive Breastfeeding
Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement: If you are currently breastfeeding, are you: * Exclusively breastfeeding * Breastfeeding and supplementing breastfeeding with bottles of breast milk * Breastfeeding and supplementing breastfeeding with bottles of formula
Time frame: Up to 24 weeks postpartum.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Exclusive Breastfeeding | 13 Participants |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Exclusive Breastfeeding | 9 Participants |
Secondary
Factors Associated With Breastfeeding Discontinuation.
Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group. Subjects were asked to rate the importance of seven different factors independently, on a 4-item Likert scale from 0 = Not at all important, to 3 = Very important
Time frame: Up to 24 weeks postpartum.
Population: Some subjects provided partial data or no data at all.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I was sick | 0 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Insufficient milk | 2 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Baby got sick | 0 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I had trouble; breast issues | 0 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Provider said baby was underweight | 0 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I quit breastfeeding; life issues | 2 score on a Likert scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Baby had trouble sucking or latching | 0.5 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I quit breastfeeding; life issues | 0 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Baby had trouble sucking or latching | 3 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Baby got sick | 0 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I was sick | 0 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Provider said baby was underweight | 0 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | Insufficient milk | 2 score on a Likert scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Factors Associated With Breastfeeding Discontinuation. | I had trouble; breast issues | 1.5 score on a Likert scale |
Comparison: Baby had trouble sucking or latchingp-value: 0.221Wilcoxon (Mann-Whitney)
Comparison: Baby got sickp-value: 0.786Wilcoxon (Mann-Whitney)
Comparison: I was sickp-value: 0.064Wilcoxon (Mann-Whitney)
Comparison: Provider said baby was underweightp-value: 0.044Wilcoxon (Mann-Whitney)
Comparison: Insufficient milkp-value: 0.666Wilcoxon (Mann-Whitney)
Comparison: I had trouble; breast issuesp-value: 0.006Wilcoxon (Mann-Whitney)
Comparison: I quit breastfeeding; life issuesp-value: 0.476Wilcoxon (Mann-Whitney)
Secondary
Postpartum Bleeding Days
To compare the total number of days of postpartum bleeding in the immediate versus standard group. This is a secondary outcome for which analysis is ongoing.
Time frame: At 2, 4, and 8 weeks postpartum.
Population: Some subjects provided partial data: i.e. only provided responses for some days or no data at all.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 2 weeks postpartum | 14 Days with bleeding |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 4 weeks postpartum | 14 Days with bleeding |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 8 weeks postpartum | 25 Days with bleeding |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 2 weeks postpartum | 14 Days with bleeding |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 4 weeks postpartum | 12 Days with bleeding |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Bleeding Days | 8 weeks postpartum | 11 Days with bleeding |
Comparison: 2 weeks postpartump-value: 0.6Wilcoxon (Mann-Whitney)
Comparison: 4 weeks postpartump-value: 0.07Wilcoxon (Mann-Whitney)
Comparison: 8 weeks postpartump-value: 0.36Wilcoxon (Mann-Whitney)
Secondary
Postpartum Mood
To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, and 8 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.
Time frame: At 2, 4, and 8 weeks postpartum.
Population: Some subjects provided partial data or no data at all.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Mood | 2 weeks postpartum | 2 EPDS Score |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Mood | 4 weeks postpartum | 2 EPDS Score |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Postpartum Mood | 8 weeks postpartum | 3 EPDS Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Mood | 2 weeks postpartum | 1 EPDS Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Mood | 4 weeks postpartum | 4 EPDS Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Postpartum Mood | 8 weeks postpartum | 4 EPDS Score |
Comparison: 2 weeks postpartump-value: 0.264Wilcoxon (Mann-Whitney)
Comparison: 4 weeks postpartump-value: 0.414Wilcoxon (Mann-Whitney)
Comparison: 8 weeks postpartump-value: 0.482Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With Postpartum Contraception Counseling
Person-Centered Contraceptive Counseling Measure (PCCC Measure) pcccmeasure.ucsf.edu Scale range: 1. Poor 2. Fair 3. Good 4. Very Good 5. Excellent Higher values represent higher satisfaction and patient-centeredness
Time frame: At enrollment.
Population: Some subjects provided partial data or no data at all.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Respecting me as a person | 5 score on a scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Letting me say what mattered to me about my birth control method | 5 score on a scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Taking my preferences about my birth control seriously | 5 score on a scale |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Giving me enough information to make the best decision about my birth control method | 5 score on a scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Giving me enough information to make the best decision about my birth control method | 5 score on a scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Respecting me as a person | 5 score on a scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Taking my preferences about my birth control seriously | 5 score on a scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Satisfaction With Postpartum Contraception Counseling | Letting me say what mattered to me about my birth control method | 5 score on a scale |
Comparison: Respecting me as a personp-value: 0.717Wilcoxon (Mann-Whitney)
Comparison: Letting me say what mattered to me about my birth control methodp-value: 0.808Wilcoxon (Mann-Whitney)
Comparison: Taking my preferences about my birth control seriouslyp-value: 0.967Wilcoxon (Mann-Whitney)
Comparison: Giving me enough information to make the best decision about my birth control methodp-value: 0.826Wilcoxon (Mann-Whitney)
Secondary
Satisfaction With the ENG Implant
Using a questionnaire the investigators seek to compare participant satisfaction with the ENG implant between the immediate versus the standard group. Scale: 0= Unsatisfied, 1=Satisfied, 2=Very satisfied
Time frame: At 8 weeks postpartum
Population: Some subjects provided partial data or no data at all.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Satisfaction With the ENG Implant | 1 score on a scale |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Satisfaction With the ENG Implant | 1 score on a scale |
p-value: 0.0376Wilcoxon (Mann-Whitney)
Secondary
Sexual Function
To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above. For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.
Time frame: At 4, 8, and 12 weeks postpartum
Population: Some subjects provided partial data or no data at all.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Sexual Function | 4 weeks postpartum | 6 FSFI Score |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Sexual Function | 8 weeks postpartum | 16 FSFI Score |
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Sexual Function | 12 weeks postpartum | 19.9 FSFI Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Sexual Function | 4 weeks postpartum | 6 FSFI Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Sexual Function | 8 weeks postpartum | 18.5 FSFI Score |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Sexual Function | 12 weeks postpartum | 21.9 FSFI Score |
Comparison: 4 weeks postpartump-value: 0.583Wilcoxon (Mann-Whitney)
Comparison: 8 weeks postpartump-value: 0.062Wilcoxon (Mann-Whitney)
Comparison: 12 weeks postpartump-value: 0.705Wilcoxon (Mann-Whitney)
Secondary
Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups.
To compare timing of breastfeeding discontinuation through 6 months postpartum between the immediate versus the standard group.
Time frame: Up to 24 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate: Implant Placed Within 24 Hours Postpartum -- Modified Intention-to-treat | Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups. | 24 Participants |
| Standard: Implant Placed at Least 2 Weeks Postpartum -- Modified Intention-to-treat | Timing of Breastfeeding Discontinuation Through 24 Weeks Postpartum Between Immediate and Standard Groups. | 24 Participants |