Breastfeeding, Contraception
Conditions
Keywords
Minipill, Progestin-only Pill, Postpartum, Slynd, Camila, Micronor, Infant growth, Breastmilk, Drospirenone, Norethindrone
Brief summary
This study will assess the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills (POPs) on maternal, breastmilk, and infant outcomes.
Detailed description
This is a placebo-controlled randomized controlled trial enrolling dyads of birthing people and their newborn infants. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth. Birthing people will be randomly assigned to 1 of 3 groups and will be blinded to group assignment: 1. immediate initiation of drospirenone-containing progestin-only pills (d-POPs), 2. immediate initiation of norethindrone-containing progestin-only pills (n-POPs) 3. immediate initiation of a placebo pill for one month followed by d-POPs.
Interventions
DRUGProgestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age and older * Desires to use POPs for 3 months * Speak English or Spanish * Had a vaginal or cesarean delivery of a singleton full term (≥37 weeks) infant less than 168 hours prior * Intends to breastfeed exclusively for 6 months
Exclusion criteria
* Desire another pregnancy in less than 6 months * Do not intend to exclusively breastfeed * Do not have access to a telephone * Have any medical contraindication to POPs * Have any contraindication to breastfeeding, including maternal illegal drug use, history of augmentation or reduction, infant with major congenital anomaly * Cognitively impaired * Currently incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. | 8 weeks postpartum | Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Bleeding | 8 weeks postpartum | Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey. |
| Satisfaction With Assigned POP | 8 weeks postpartum | Overall satisfaction and if birthing people would recommend the POP they were assigned to use to a friend will be ascertained from an email self-report survey. Counts are the number of birthing people who responded yes. |
| Protein Content of Human Milk | 4 weeks postpartum | Mid-feeding milk samples will be pumped by birthing people and analyzed. |
| Carbohydrate Content of Human Milk | 4 weeks postpartum | Mid-feeding milk samples will be pumped by birthing people and analyzed. |
| Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum | 8 weeks postpartum | Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey. |
| Perception of Milk Supply | 8 weeks postpartum | Self-reported perception of adequacy of milk supply will be collected with the 20-item Hill and Humenick Lactation Scale among birthing people. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding. |
| Change in Infant Weight | Baseline and 4 weeks after delivery | Infant weight in grams will be compared over 4 weeks. |
| Change in Infant Height | Baseline and 4 weeks after delivery | Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks. |
| Change in Infant Head Circumference | Baseline and 4 weeks after delivery | The maximum diameter through the infant's glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks. |
| Fat Content of Human Milk | 4 weeks postpartum | Mid-feeding milk samples will be pumped by birthing people and analyzed. |
Countries
United States
Participant flow
Pre-assignment details
Numbers represent dyads of the birthing person and infant.
Participants by arm
| Arm | Count |
|---|---|
| Early Initiation d-POPs Initiation of d-POPs 120-160 hours after delivery. Dosing is 4mg daily for 24 days followed by 4 daily inactive tablets for 2 months.
Progestin Only Contraceptive Pills: Daily pill (placebo or active tablet) | 10 |
| Early Initiation n-POPs Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months.
Progestin Only Contraceptive Pills: Daily pill (placebo or active tablet) | 10 |
| Interval Initiation of d-POPs Placebo starting 120-160 hours after delivery, continuing for 28 days. Followed by 24 days of 4mg daily of d-POPs and 4 daily inactive tablets.
Progestin Only Contraceptive Pills: Daily pill (placebo or active tablet) | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Early Initiation d-POPs | Total | Interval Initiation of d-POPs | Early Initiation n-POPs |
|---|---|---|---|---|
| Age, Continuous | 31.6 years STANDARD_DEVIATION 5.6 | 30.4 years STANDARD_DEVIATION 5.6 | 28.4 years STANDARD_DEVIATION 3.6 | 31.2 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 12 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 18 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Highest education level achieved Completed graduate degree | 2 Participants | 7 Participants | 3 Participants | 2 Participants |
| Highest education level achieved High school or less | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Highest education level achieved Post-high school, technical school | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Highest education level achieved Some college | 2 Participants | 5 Participants | 3 Participants | 0 Participants |
| Highest education level achieved Some graduate degree | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Highest education level achieved Undergraduate degree | 5 Participants | 13 Participants | 2 Participants | 6 Participants |
| Infant birth head circumference | 34.3 Centimeters STANDARD_DEVIATION 1.7 | 34.74 Centimeters STANDARD_DEVIATION 1.4 | 35.0 Centimeters STANDARD_DEVIATION 0.7 | 34.9 Centimeters STANDARD_DEVIATION 1.5 |
| Infant birth length | 51.2 Centimeters STANDARD_DEVIATION 2.1 | 51.06 Centimeters STANDARD_DEVIATION 2.3 | 50.4 Centimeters STANDARD_DEVIATION 2.2 | 51.6 Centimeters STANDARD_DEVIATION 2.7 |
| Infant birth weight | 3432 Grams STANDARD_DEVIATION 546 | 3456 Grams STANDARD_DEVIATION 453 | 3502 Grams STANDARD_DEVIATION 484 | 3433 Grams STANDARD_DEVIATION 354 |
| Infant sex at birth Female | 6 Infants of the dyad | 15 Infants of the dyad | 3 Infants of the dyad | 6 Infants of the dyad |
| Infant sex at birth Male | 4 Infants of the dyad | 15 Infants of the dyad | 7 Infants of the dyad | 4 Infants of the dyad |
| Prior delivery | 2 Participants | 9 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 7 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 1 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 | 3 Participants | 6 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 3 Participants | 13 Participants | 6 Participants | 4 Participants |
| Region of Enrollment United States | 10 birthing person/infant dyad | 30 birthing person/infant dyad | 10 birthing person/infant dyad | 10 birthing person/infant dyad |
| Sex: Female, Male Female | 10 Participants | 30 Participants | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Using donor milk to supplement feeding in hospital | 4 Participants | 9 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
Time frame: 8 weeks postpartum
Population: Lactation status was reported by 22 birthing people at 8 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Initiation d-POPs | Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. | 7 Participants |
| Early Initiation n-POPs | Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. | 7 Participants |
| Interval Initiation of d-POPs | Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. | 6 Participants |
Secondary
Carbohydrate Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
Population: 20 total milk samples collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Carbohydrate Content of Human Milk | 9.11 ng/dL | Standard Deviation 0.61 |
| Early Initiation n-POPs | Carbohydrate Content of Human Milk | 8.75 ng/dL | Standard Deviation 0.4 |
| Interval Initiation of d-POPs | Carbohydrate Content of Human Milk | 9.25 ng/dL | Standard Deviation 1.02 |
Secondary
Change in Infant Head Circumference
The maximum diameter through the infant's glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks.
Time frame: Baseline and 4 weeks after delivery
Population: 20 infants measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Change in Infant Head Circumference | 8.4 Percent difference | Standard Deviation 5 |
| Early Initiation n-POPs | Change in Infant Head Circumference | 7.3 Percent difference | Standard Deviation 3.8 |
| Interval Initiation of d-POPs | Change in Infant Head Circumference | 7.4 Percent difference | Standard Deviation 3.5 |
Secondary
Change in Infant Height
Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
Time frame: Baseline and 4 weeks after delivery
Population: 20 infants measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Change in Infant Height | 7.2 Percent difference | Standard Deviation 2.6 |
| Early Initiation n-POPs | Change in Infant Height | 3.6 Percent difference | Standard Deviation 4 |
| Interval Initiation of d-POPs | Change in Infant Height | 6.8 Percent difference | Standard Deviation 6.1 |
Secondary
Change in Infant Weight
Infant weight in grams will be compared over 4 weeks.
Time frame: Baseline and 4 weeks after delivery
Population: 20 infants weighed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Change in Infant Weight | 20.9 Percent difference | Standard Deviation 13.1 |
| Early Initiation n-POPs | Change in Infant Weight | 28.4 Percent difference | Standard Deviation 9 |
| Interval Initiation of d-POPs | Change in Infant Weight | 30.8 Percent difference | Standard Deviation 18.7 |
Secondary
Fat Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
Population: 20 total milk samples collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Fat Content of Human Milk | 3.79 ng/dL | Standard Deviation 0.71 |
| Early Initiation n-POPs | Fat Content of Human Milk | 3.53 ng/dL | Standard Deviation 1.14 |
| Interval Initiation of d-POPs | Fat Content of Human Milk | 3.24 ng/dL | Standard Deviation 0.61 |
Secondary
Perception of Milk Supply
Self-reported perception of adequacy of milk supply will be collected with the 20-item Hill and Humenick Lactation Scale among birthing people. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding.
Time frame: 8 weeks postpartum
Population: Perception of milk supply was reported by 22 birthing people at 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Perception of Milk Supply | 95.1 Mean scale score | Standard Deviation 8 |
| Early Initiation n-POPs | Perception of Milk Supply | 96.5 Mean scale score | Standard Deviation 7.9 |
| Interval Initiation of d-POPs | Perception of Milk Supply | 92.5 Mean scale score | Standard Deviation 6.7 |
Secondary
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
Time frame: 8 weeks postpartum
Population: Progestin-only pill use was reported by 22 birthing people at 8 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Initiation d-POPs | Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum | 7 Participants |
| Early Initiation n-POPs | Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum | 8 Participants |
| Interval Initiation of d-POPs | Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum | 4 Participants |
Secondary
Protein Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Time frame: 4 weeks postpartum
Population: 20 total milk samples were collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Protein Content of Human Milk | 1.49 ng/dL | Standard Deviation 0.18 |
| Early Initiation n-POPs | Protein Content of Human Milk | 1.46 ng/dL | Standard Deviation 0.29 |
| Interval Initiation of d-POPs | Protein Content of Human Milk | 1.26 ng/dL | Standard Deviation 0.28 |
Secondary
Satisfaction With Assigned POP
Overall satisfaction and if birthing people would recommend the POP they were assigned to use to a friend will be ascertained from an email self-report survey. Counts are the number of birthing people who responded yes.
Time frame: 8 weeks postpartum
Population: Satisfaction with assigned POP was reported by 22 birthing people at 8 weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Initiation d-POPs | Satisfaction With Assigned POP | 6 Participants |
| Early Initiation n-POPs | Satisfaction With Assigned POP | 8 Participants |
| Interval Initiation of d-POPs | Satisfaction With Assigned POP | 5 Participants |
Secondary
Vaginal Bleeding
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
Time frame: 8 weeks postpartum
Population: Vaginal bleeding was reported by 22 birthing people at 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Initiation d-POPs | Vaginal Bleeding | 0.1 days | Standard Deviation 0.4 |
| Early Initiation n-POPs | Vaginal Bleeding | 2.7 days | Standard Deviation 3.1 |
| Interval Initiation of d-POPs | Vaginal Bleeding | 0.2 days | Standard Deviation 0.4 |