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Progestin-Only Pill Use and Breastfeeding Study

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ClinicalTrials.gov Identifier: NCT04965116
Recruitment Status : Not yet recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Sarah Averbach, MD MAS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Contraception Breastfeeding Drug: Progestin Only Contraceptive Pills Phase 4

Detailed Description:

This is a placebo-controlled randomized controlled trial enrolling dyads of mothers and their newborn babies. 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.

Women 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Progestin-Only Pill Use and Breastfeeding Study
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: 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.
Drug: Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Names:
  • Slynd
  • Camila
  • Micronor
  • Errin

Experimental: Early Initiation n-POPs
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
Daily pill (placebo or active tablet)
Other Names:
  • Slynd
  • Camila
  • Micronor
  • Errin

Placebo Comparator: 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.
Drug: Progestin Only Contraceptive Pills
Daily pill (placebo or active tablet)
Other Names:
  • Slynd
  • Camila
  • Micronor
  • Errin




Primary Outcome Measures :
  1. Proportion of participants exclusively breastfeeding at 2 months postpartum [ Time Frame: 8 weeks postpartum ]
    Exclusive breastfeeding will be assessed at 8 weeks postpartum through an email self-reported survey. Type of infant feeding will be collected weekly beginning with enrollment to ascertain the length of time exclusively breastfeeding and date of stopping if applicable.


Secondary Outcome Measures :
  1. Breastfeeding supplementation type [ Time Frame: Weeks 2-8 postpartum ]
    If not exclusively breastfeeding, type of supplementation will be collected via text and email surveys.

  2. Proportion of participants using progestin-only pills at 2 months postpartum [ Time Frame: 8 weeks postpartum ]
    Type of contraception being used at 8 weeks postpartum will be assessed through an email self-reported survey.

  3. Vaginal bleeding [ Time Frame: 4 and 8 weeks postpartum ]
    Number of days of any bleeding and spotting in last month will be collected via self-reported email survey.

  4. Satisfaction with contraception method [ Time Frame: 4 and 8 weeks postpartum ]
    Overall satisfaction and if participants would recommend the current method of contraception they are using to a friend will be ascertained from an email self-report survey.

  5. Protein content of breastmilk [ Time Frame: 4 weeks postpartum ]
    Mid-feeding breastmilk samples will be collected and analyzed.

  6. Carbohydrate content of breastmilk [ Time Frame: 4 weeks postpartum ]
    Mid-feeding breastmilk samples will be collected and analyzed.

  7. Fat content of breastmilk [ Time Frame: 4 weeks postpartum ]
    Mid-feeding breastmilk samples will be collected and analyzed.

  8. Maternal perception of milk supply [ Time Frame: 4 and 8 weeks postpartum ]
    Self-reported perception of adequacy of breastmilk supply will be collected with the 20-item Hill and Humenick Lactation Scale. Minimum scale score is 20 and maximum is 140, with higher scores representing a more positive perception of breastfeeding.

  9. Change in infant weight [ Time Frame: Baseline and 4 weeks after delivery ]
    Weight in grams will be compared over 4 weeks.

  10. Change in infant height [ Time Frame: Baseline and 4 weeks after delivery ]
    Length as measured on a marked board to the nearest millimeter will be compared over 4 weeks.

  11. Change in infant head circumference [ Time Frame: Baseline and 4 weeks after delivery ]
    The maximum diameter through the glabella and occiput is found and measured with a tape measure and recorded to the nearest millimeter and compared over 4 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 13 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965116


Contacts
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Contact: Gennifer Kully, MSc 858-329-4464 familyplanningresearch@health.ucsd.edu

Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Contact: Gennifer Kully, MSc    858-329-4464    familyplanningresearch@health.ucsd.edu   
Principal Investigator: Sarah Averbach, MD, MAS         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Sarah Averbach, MD, MAS University of California, San Diego
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Responsible Party: Sarah Averbach, MD MAS, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04965116    
Other Study ID Numbers: 210357
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sarah Averbach, MD MAS, University of California, San Diego:
Minipill
Progestin-only Pill
Postpartum
Slynd
Camila
Micronor
Infant growth
Breastmilk
Drospirenone
Norethindrone
Additional relevant MeSH terms:
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Contraceptive Agents
Progestins
Reproductive Control Agents
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists