ContraceptionPhase 4NCT04965116
Progestin-Only Pill Use and Breastfeeding Study
A Phase 4 study testing Progestin Only Contraceptive Pills in people with Contraception and Breastfeeding, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Breastfeeding
- What is being tested?
- Progestin Only Contraceptive Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 4 Nov 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
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.
Read the 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:
- immediate initiation of drospirenone-containing progestin-only pills (d-POPs),
- immediate initiation of norethindrone-containing progestin-only pills (n-POPs)
- immediate initiation of a placebo pill for one month followed by d-POPs.
- Conditions
- Contraception, Breastfeeding
- Being tested
- Progestin Only Contraceptive Pills
- Keywords
- Minipill, Progestin-only Pill, Postpartum, Slynd, Camila, Micronor, Infant growth, Breastmilk, Drospirenone, Norethindrone
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progestin Only Contraceptive PillsDrug
Also called Slynd, Camila, Micronor, Errin
Daily pill (placebo or active tablet)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Progestin Only Contraceptive Pills |
| 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. Receives: Drug: Progestin Only Contraceptive Pills |
| 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. Receives: Drug: Progestin Only Contraceptive Pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
Measured: 8 weeks postpartum
Secondary outcomes (10)
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.
Measured: 8 weeks postpartum
Vaginal Bleeding
Number of days of any bleeding and spotting among birthing people in last week will be collected via self-reported email survey.
Measured: 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".
Measured: 8 weeks postpartum
Protein Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Measured: 4 weeks postpartum
Carbohydrate Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Measured: 4 weeks postpartum
Fat Content of Human Milk
Mid-feeding milk samples will be pumped by birthing people and analyzed.
Measured: 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.
Measured: 8 weeks postpartum
Change in Infant Weight
Infant weight in grams will be compared over 4 weeks.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start25 Oct 2021
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Sarah Averbach, MD, MAS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965116
- Sponsor's protocol ID
- 210357
- Status last verified
- Apr 2024
- First submitted
- 26 Jun 2021
- Last updated
- 19 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progestin-Only Pill Use and Breastfeeding Study
- ClinicalTrials.gov ID
- NCT04965116
- Acronym / sponsor ID
- 210357
- Conditions
- Contraception, Breastfeeding
- Keywords
- Minipill, Progestin-only Pill, Postpartum, Slynd, Camila, Micronor, Infant growth, Breastmilk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 19 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- immediate initiation of drospirenone-containing progestin-only pills (d-POPs),
- immediate initiation of norethindrone-containing progestin-only pills (n-POPs)
- immediate initiation of a placebo pill for one month followed by d-POPs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early Initiation d-POPs | Experimental | Drug: Progestin Only Contraceptive PillsInitiation 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 | Drug: Progestin Only Contraceptive PillsInitiation 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 | Drug: Progestin Only Contraceptive PillsPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progestin Only Contraceptive PillsAlso: Slynd, Camila, Micronor, ErrinDaily pill (placebo or active tablet) | Drug | Early Initiation d-POPs, Early Initiation n-POPs, Interval Initiation of d-POPs |
Primary outcome
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum.
Time frame: 8 weeks postpartum
Lactation status will be assessed at 8 weeks postpartum through an email self-reported survey.
10 secondary outcomes
Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum
Time frame: 8 weeks postpartum
Vaginal Bleeding
Time frame: 8 weeks postpartum
Satisfaction With Assigned POP
Time frame: 8 weeks postpartum
Protein Content of Human Milk
Time frame: 4 weeks postpartum
Carbohydrate Content of Human Milk
Time frame: 4 weeks postpartum
Fat Content of Human Milk
Time frame: 4 weeks postpartum
Perception of Milk Supply
Time frame: 8 weeks postpartum
Change in Infant Weight
Time frame: Baseline and 4 weeks after delivery
Change in Infant Height
Time frame: Baseline and 4 weeks after delivery
Change in Infant Head Circumference
Time frame: Baseline and 4 weeks after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Averbach, MD, MAS principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progestin Only Contraceptive Pills in people with Contraception and Breastfeeding, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive Lactation Among Birthing People at 8 Weeks Postpartum. (time frame: 8 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.