NCT01465022

Brief Summary

Objectives To clarify the relationship between postpartum (2 weeks) use of progestin-only vs. combined oral contraceptive pills and the outcomes of breastfeeding continuation, infant growth, contraceptive method continuation, and pregnancy rates in breastfeeding women. Specific research questions:

  1. 1.To determine whether there is a difference in rates of breastfeeding continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.
  2. 2.To determine whether there is a difference in infant growth at 2 weeks and 8 weeks between postpartum breastfeeding women using progestin-only pills vs. combined pills.
  3. 3.To determine whether there is a difference in birth control method continuation at 2 months and 4 months between postpartum breastfeeding women using progestin-only pills vs. combined pills.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 15, 2016

Completed
Last Updated

May 20, 2016

Status Verified

February 1, 2016

Enrollment Period

3.4 years

First QC Date

November 1, 2011

Results QC Date

May 29, 2015

Last Update Submit

April 14, 2016

Conditions

Breast FeedingContraception

Keywords

Breastfeeding ratesContraceptive continuationBirth control pillsLactation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Continued to Breastfeed at 6 Months

    Proportion of participants who are continuing to breastfeed from 2 months to 6 months after delivery

    Baseline to Week 8, Week 8, 2-6 months

Secondary Outcomes (4)

  • Number of Participants Who Continued Birth Control Method After 6 Months

    Baseline to Week 8, Week 8, 2-6 months

  • Infant Length Growth From 2-8 Weeks

    Week 2 and Week 8

  • Infant Weight Growth From 2-8 Weeks

    Week 2 and Week 8

  • Infant Occipitofrontal Circumference Growth From 2-8 Weeks

    Week 2 and Week 8

Study Arms (2)

Study Arm A

ACTIVE COMPARATOR

Study Arm A is one of two interventions (Combined estrogen-progestin pill)

Drug: Combined estrogen-progestin pill

Study Arm B

ACTIVE COMPARATOR

Study Arm B is one of two interventions (Progestin-only pill)

Drug: Progestin-only pill

Interventions

Combined estrogen-progestin pillDRUG

1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo

Also known as: OCP
Study Arm A
Progestin-only pillDRUG

.35 mg norethindrone once a day orally

Also known as: POP
Study Arm B

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • able to give informed consent
  • postpartum women delivering at the University of New Mexico Hospital
  • Intend to breastfeed
  • Plan to use oral contraceptives as her family planning method
  • Willing to be randomized to either progestin-only pills or combined pills

You may not qualify if:

  • medical contraindications to combined pills including history of thromboembolism, uncontrolled hypertension or complex migraine headaches
  • preterm birth (\<37 weeks)
  • small for gestational age infant (\<2500 grams)
  • large for gestational age infant (\>4500 grams)
  • infant with major congenital anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Espey E, Ogburn T, Leeman L, Singh R, Ostrom K, Schrader R. Effect of progestin compared with combined oral contraceptive pills on lactation: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):5-13. doi: 10.1097/AOG.0b013e31823dc015.

    PMID: 22143258DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Results Point of Contact

Title
Eve Espey MD, MPH, Principal Investigator
Organization
University of New Mexico
eespey@salud.unm.edu
505 272 6372

Study Officials

  • Eve Espey, MD

    UNM OB Gyn

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, OB-GYN

Study Record Dates

First Submitted

November 1, 2011

First Posted

November 4, 2011

Study Start

January 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 20, 2016

Results First Posted

January 15, 2016

Record last verified: 2016-02