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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Initiation d-POPs | Experimental | 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. |
|
| Early Initiation n-POPs | Experimental | Initiation of n-POPs 120-160 hours after delivery. Dosing is 0.35mg daily for 28 days for 2 months. |
|
| Interval Initiation of d-POPs | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progestin Only Contraceptive Pills | Drug | Daily pill (placebo or active tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. | Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey. | 8 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks postpartum |
| Vaginal Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Averbach, MD, MAS | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States |
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Numbers represent dyads of the birthing person and infant.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
There are 30 total dyads enrolled, 30 birthing people and their respective 30 newborn infants. The unit of the dyad is specified for each characteristic and was either self-reported by the birthing person or collected via chart review for the infant.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | Early Initiation n-POPs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Birthing person |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Lactation status was reported by 22 birthing people at 8 weeks. | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
8 weeks
In this section, participants are considered individually rather than in dyads. This number equals 30 birthing people and 30 infants, making the total sample reported 60.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Averbach, MD, MAS | University of California, San Diego | 858-329-4464 | familyplanningresearch@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2021 | Oct 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009640 | Norethindrone |
| ID | Term |
|---|---|
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 |
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|
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
| 8 weeks postpartum |
| 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". | 8 weeks postpartum |
| Protein Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 4 weeks postpartum |
| Carbohydrate Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 4 weeks postpartum |
| Fat Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 4 weeks postpartum |
| 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. | 8 weeks postpartum |
| Change in Infant Weight | Infant weight in grams will be compared over 4 weeks. | Baseline and 4 weeks after delivery |
| Change in Infant Height | Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks. | Baseline and 4 weeks after delivery |
| 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. | Baseline and 4 weeks after delivery |
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) |
| BG002 | 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) |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex of the birthing person | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity of the birthing person | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of the birthing person | Count of Participants | Participants |
|
| Region of Enrollment | Birthing person/infant dyads enrolled in the United States. | Number | birthing person/infant dyad |
|
| Prior delivery | Birthing people who have had a prior delivery. | Count of Participants | Participants |
|
| Highest education level achieved | Highest education level achieved by birthing person. | Count of Participants | Participants |
|
| Using donor milk to supplement feeding in hospital | Number of birthing people using donor milk to feed their infant. | Count of Participants | Participants |
|
| Infant sex at birth | Number of infants by sex. | Number | Infants of the dyad |
|
| Infant birth length | Infant birth length in centimeters. | Mean | Standard Deviation | Centimeters |
|
| Infant birth weight | Infant birth weight in grams. | Mean | Standard Deviation | Grams |
|
| Infant birth head circumference | Infant head circumference in centimeters at birth. | Mean | Standard Deviation | Centimeters |
|
| OG002 | 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) |
|
|
| 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. | Progestin-only pill use was reported by 22 birthing people at 8 weeks. | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
|
|
| 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. | Vaginal bleeding was reported by 22 birthing people at 8 weeks. | Posted | Mean | Standard Deviation | days | 8 weeks postpartum |
|
|
|
| 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". | Satisfaction with assigned POP was reported by 22 birthing people at 8 weeks. | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
|
|
| Secondary | Protein Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 20 total milk samples were collected. | Posted | Mean | Standard Deviation | ng/dL | 4 weeks postpartum |
|
|
|
| Secondary | Carbohydrate Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 20 total milk samples collected. | Posted | Mean | Standard Deviation | ng/dL | 4 weeks postpartum |
|
|
|
| Secondary | Fat Content of Human Milk | Mid-feeding milk samples will be pumped by birthing people and analyzed. | 20 total milk samples collected | Posted | Mean | Standard Deviation | ng/dL | 4 weeks postpartum |
|
|
|
| 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. | Perception of milk supply was reported by 22 birthing people at 8 weeks. | Posted | Mean | Standard Deviation | Mean scale score | 8 weeks postpartum |
|
|
|
| Secondary | Change in Infant Weight | Infant weight in grams will be compared over 4 weeks. | 20 infants weighed. | Posted | Mean | Standard Deviation | Percent difference | Baseline and 4 weeks after delivery |
|
|
|
| Secondary | Change in Infant Height | Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks. | 20 infants measured. | Posted | Mean | Standard Deviation | Percent difference | Baseline and 4 weeks after delivery |
|
|
|
| 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. | 20 infants measured. | Posted | Mean | Standard Deviation | Percent difference | Baseline and 4 weeks after delivery |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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) | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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) | 0 | 20 | 0 | 20 | 0 | 20 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |