NCT04965116

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 19, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

June 26, 2021

Results QC Date

October 23, 2023

Last Update Submit

April 18, 2024

Conditions

ContraceptionBreastfeeding

Keywords

MinipillProgestin-only PillPostpartumSlyndCamilaMicronorInfant growthBreastmilkDrospirenoneNorethindrone

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Proportion of Birthing People Using Progestin-only Pills at 8 Weeks Postpartum

    8 weeks postpartum

  • Vaginal Bleeding

    8 weeks postpartum

  • Satisfaction With Assigned POP

    8 weeks postpartum

  • Protein Content of Human Milk

    4 weeks postpartum

  • Carbohydrate Content of Human Milk

    4 weeks postpartum

  • +5 more secondary outcomes

Study Arms (3)

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.

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.

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.

Drug: Progestin Only Contraceptive Pills

Interventions

Progestin Only Contraceptive PillsDRUG

Daily pill (placebo or active tablet)

Also known as: Slynd, Camila, Micronor, Errin
Early Initiation d-POPsEarly Initiation n-POPsInterval Initiation of d-POPs

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Norethindrone

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Sarah Averbach, MD, MAS
Organization
University of California, San Diego
familyplanningresearch@health.ucsd.edu
858-329-4464

Study Officials

  • Sarah Averbach, MD, MAS

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 26, 2021

First Posted

July 16, 2021

Study Start

October 25, 2021

Primary Completion

November 4, 2022

Study Completion

November 4, 2022

Last Updated

April 19, 2024

Results First Posted

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)