Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2021-10-25
2022-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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)
Interventions
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Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
Yes
Sponsors
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University of California, San Diego
OTHER
Responsible Party
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Sarah Averbach, MD MAS
Associate Professor
Principal Investigators
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Sarah Averbach, MD, MAS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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210357
Identifier Type: -
Identifier Source: org_study_id
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