Breastfeeding, Contraception, Postpartum Contraception
Conditions
Brief summary
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period
Detailed description
Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply. The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant. Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.
Interventions
Women will be randomized to the TIMING of implant placement
Sponsors
Society of Family Planning
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Live pregnancy of at least 24 weeks gestation * Intention to use a contraceptive implant postpartum * 17 years of age or older * English or Spanish speaking * Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible) * The presence of at least one of the following conditions known to be a risk factor for low milk supply: * Expected delivery prior to 34 weeks * Obesity (pre-pregnancy BMI \>35) * Polycystic Ovarian Syndrome * Diabetes (gestational or pre-gestational) * Self-reported difficulty with low milk supply in past
Exclusion criteria
* Not English or Spanish speaking * Allergy or Contraindication to contraceptive implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Breastfeeding at 6 Months | 6 months postpartum | Exclusive Breastfeeding at 6 months |
| Time to Lactogenesis Stage II | 1-5 days postpartum | Difference in time to Lactogenesis Stage II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Bleeding | 0-6 months postpartum | Number of Participants that reported heavy bleeding at 6 months postpartum |
| Satisfaction With Contraceptive Implant | 0-6 months postpartum | Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Postplacental contraceptive implant placed within 30 minutes of placental delivery
Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 51 |
| Immediate Postpartum Contraceptive Implant placed 1-3 days postpartum
Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 52 |
| Delayed Contraceptive Implant placed 6 or more weeks postpartum
Etonogestrel Contraceptive Implant: Women will be randomized to the TIMING of implant placement | 52 |
| Total | 155 |
Baseline characteristics
| Characteristic | Postplacental | Immediate Postpartum | Delayed | Total |
|---|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 4.5 | 27 years STANDARD_DEVIATION 4.6 | 27 years STANDARD_DEVIATION 4.8 | 27 years STANDARD_DEVIATION 4.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 32 Participants | 31 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 17 Participants | 18 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants | 18 Participants | 22 Participants | 65 Participants |
| Race (NIH/OMB) More than one race | 17 Participants | 24 Participants | 24 Participants | 65 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Female | 51 Participants | 52 Participants | 52 Participants | 155 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 0 / 51 | 0 / 52 | 0 / 52 |
| serious Total, serious adverse events | 0 / 51 | 0 / 52 | 0 / 52 |
Outcome results
Primary
Number of Participants Breastfeeding at 6 Months
Exclusive Breastfeeding at 6 months
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postplacental | Number of Participants Breastfeeding at 6 Months | 6 Participants |
| Immediate Postpartum | Number of Participants Breastfeeding at 6 Months | 4 Participants |
| Delayed | Number of Participants Breastfeeding at 6 Months | 6 Participants |
Primary
Time to Lactogenesis Stage II
Difference in time to Lactogenesis Stage II
Time frame: 1-5 days postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postplacental | Time to Lactogenesis Stage II | 66.9 hours | Standard Deviation 27.2 |
| Immediate Postpartum | Time to Lactogenesis Stage II | 62.1 hours | Standard Deviation 29 |
| Delayed | Time to Lactogenesis Stage II | 57.3 hours | Standard Deviation 21.7 |
Secondary
Satisfaction With Contraceptive Implant
Satisfaction on a 1-10 scale (10 being highly satisfied) at 6 months postpartum
Time frame: 0-6 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postplacental | Satisfaction With Contraceptive Implant | 8.41 score on a scale | Standard Deviation 2.01 |
| Immediate Postpartum | Satisfaction With Contraceptive Implant | 8.14 score on a scale | Standard Deviation 2.47 |
| Delayed | Satisfaction With Contraceptive Implant | 8.69 score on a scale | Standard Deviation 1.6 |
Secondary
Vaginal Bleeding
Number of Participants that reported heavy bleeding at 6 months postpartum
Time frame: 0-6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Postplacental | Vaginal Bleeding | 7 Participants |
| Immediate Postpartum | Vaginal Bleeding | 6 Participants |
| Delayed | Vaginal Bleeding | 4 Participants |