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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Immediate v. Standard insertion.
Implant.
University of New Mexico
Albuquerque, New Mexico, United States
University of Utah
Salt Lake City, Utah, United States
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.
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.
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.
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.
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.
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Time frame: At 2, 4, and 8 weeks postpartum.
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
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.
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
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