Trial Outcomes & Findings for Progestin-Only Pill Use and Breastfeeding Study (NCT NCT04965116)
NCT ID: NCT04965116
Last Updated: 2024-04-19
Results Overview
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
8 weeks postpartum
Results posted on
2024-04-19
Participant Flow
Numbers represent dyads of the birthing person and infant.
Participant milestones
| Measure |
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)
|
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)
|
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Progestin-Only Pill Use and Breastfeeding Study
Baseline characteristics by cohort
| Measure |
Early Initiation d-POPs
n=10 Participants
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)
|
Early Initiation n-POPs
n=10 Participants
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)
|
Interval Initiation of d-POPs
n=10 Participants
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)
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
28.4 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
30.4 years
STANDARD_DEVIATION 5.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 birthing person/infant dyad
n=5 Participants
|
10 birthing person/infant dyad
n=7 Participants
|
10 birthing person/infant dyad
n=5 Participants
|
30 birthing person/infant dyad
n=4 Participants
|
|
Prior delivery
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Highest education level achieved
High school or less
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Highest education level achieved
Post-high school, technical school
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Highest education level achieved
Some college
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Highest education level achieved
Undergraduate degree
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Highest education level achieved
Some graduate degree
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Highest education level achieved
Completed graduate degree
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Using donor milk to supplement feeding in hospital
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Infant sex at birth
Female
|
6 Infants of the dyad
n=5 Participants
|
6 Infants of the dyad
n=7 Participants
|
3 Infants of the dyad
n=5 Participants
|
15 Infants of the dyad
n=4 Participants
|
|
Infant sex at birth
Male
|
4 Infants of the dyad
n=5 Participants
|
4 Infants of the dyad
n=7 Participants
|
7 Infants of the dyad
n=5 Participants
|
15 Infants of the dyad
n=4 Participants
|
|
Infant birth length
|
51.2 Centimeters
STANDARD_DEVIATION 2.1 • n=5 Participants
|
51.6 Centimeters
STANDARD_DEVIATION 2.7 • n=7 Participants
|
50.4 Centimeters
STANDARD_DEVIATION 2.2 • n=5 Participants
|
51.06 Centimeters
STANDARD_DEVIATION 2.3 • n=4 Participants
|
|
Infant birth weight
|
3432 Grams
STANDARD_DEVIATION 546 • n=5 Participants
|
3433 Grams
STANDARD_DEVIATION 354 • n=7 Participants
|
3502 Grams
STANDARD_DEVIATION 484 • n=5 Participants
|
3456 Grams
STANDARD_DEVIATION 453 • n=4 Participants
|
|
Infant birth head circumference
|
34.3 Centimeters
STANDARD_DEVIATION 1.7 • n=5 Participants
|
34.9 Centimeters
STANDARD_DEVIATION 1.5 • n=7 Participants
|
35.0 Centimeters
STANDARD_DEVIATION 0.7 • n=5 Participants
|
34.74 Centimeters
STANDARD_DEVIATION 1.4 • n=4 Participants
|
PRIMARY outcome
Timeframe: 8 weeks postpartumPopulation: Lactation status was reported by 22 birthing people at 8 weeks.
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=9 Participants
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)
|
Interval Initiation of d-POPs
n=6 Participants
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)
|
|---|---|---|---|
|
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
|
7 Participants
|
7 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 8 weeks postpartumPopulation: Progestin-only pill use was reported by 22 birthing people at 8 weeks.
Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=9 Participants
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)
|
Interval Initiation of d-POPs
n=6 Participants
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)
|
|---|---|---|---|
|
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
|
7 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8 weeks postpartumPopulation: Vaginal bleeding was reported by 22 birthing people at 8 weeks.
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=9 Participants
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)
|
Interval Initiation of d-POPs
n=6 Participants
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)
|
|---|---|---|---|
|
Vaginal Bleeding
|
0.1 days
Standard Deviation 0.4
|
2.7 days
Standard Deviation 3.1
|
0.2 days
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 8 weeks postpartumPopulation: Satisfaction with assigned POP was reported by 22 birthing people at 8 weeks.
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".
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=9 Participants
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)
|
Interval Initiation of d-POPs
n=6 Participants
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)
|
|---|---|---|---|
|
Satisfaction With Assigned POP
|
6 Participants
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: 20 total milk samples were collected.
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Protein Content of Human Milk
|
1.49 ng/dL
Standard Deviation 0.18
|
1.46 ng/dL
Standard Deviation 0.29
|
1.26 ng/dL
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: 20 total milk samples collected.
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Carbohydrate Content of Human Milk
|
9.11 ng/dL
Standard Deviation 0.61
|
8.75 ng/dL
Standard Deviation 0.40
|
9.25 ng/dL
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 4 weeks postpartumPopulation: 20 total milk samples collected
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Fat Content of Human Milk
|
3.79 ng/dL
Standard Deviation 0.71
|
3.53 ng/dL
Standard Deviation 1.14
|
3.24 ng/dL
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 8 weeks postpartumPopulation: Perception of milk supply was reported by 22 birthing people at 8 weeks.
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.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=9 Participants
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)
|
Interval Initiation of d-POPs
n=6 Participants
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)
|
|---|---|---|---|
|
Perception of Milk Supply
|
95.1 Mean scale score
Standard Deviation 8.0
|
96.5 Mean scale score
Standard Deviation 7.9
|
92.5 Mean scale score
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after deliveryPopulation: 20 infants weighed.
Infant weight in grams will be compared over 4 weeks.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Change in Infant Weight
|
20.9 Percent difference
Standard Deviation 13.1
|
28.4 Percent difference
Standard Deviation 9.0
|
30.8 Percent difference
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after deliveryPopulation: 20 infants measured.
Infant length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Change in Infant Height
|
7.2 Percent difference
Standard Deviation 2.6
|
3.6 Percent difference
Standard Deviation 4.0
|
6.8 Percent difference
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline and 4 weeks after deliveryPopulation: 20 infants measured.
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.
Outcome measures
| Measure |
Early Initiation d-POPs
n=7 Participants
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)
|
Early Initiation n-POPs
n=6 Participants
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)
|
Interval Initiation of d-POPs
n=7 Participants
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)
|
|---|---|---|---|
|
Change in Infant Head Circumference
|
8.4 Percent difference
Standard Deviation 5.0
|
7.3 Percent difference
Standard Deviation 3.8
|
7.4 Percent difference
Standard Deviation 3.5
|
Adverse Events
Early Initiation d-POPs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Early Initiation n-POPs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interval Initiation of d-POPs
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sarah Averbach, MD, MAS
University of California, San Diego
Phone: 858-329-4464
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place