Clinical trial NCT01465022: Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Official title: Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Contraception
Keywords: Breastfeeding rates
Contraceptive continuation
Birth control pills
Lactation
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: American College of Obstetricians and Gynecologists
First posted: 2011-11-04
Enrollment: 197
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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. 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. 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.

Hypothesis

Combined oral contraceptive pills, when initiated by postpartum breastfeeding women, will cause a differential in continuation of breastfeeding: 35% continuation in the combined pill group vs. 60% in the progestin-only pill group at 8 weeks.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Who Continued to Breastfeed at 6 Months
timeFrame: Baseline to Week 8, Week 8, 2-6 months
Secondary outcomes:
measure: Number of Participants Who Continued Birth Control Method After 6 Months
timeFrame: Baseline to Week 8, Week 8, 2-6 months
measure: Infant Length Growth From 2-8 Weeks
timeFrame: Week 2 and Week 8
measure: Infant Weight Growth From 2-8 Weeks
timeFrame: Week 2 and Week 8
measure: Infant Occipitofrontal Circumference Growth From 2-8 Weeks
timeFrame: Week 2 and Week 8
Other outcomes:
Locations:
Study officials:
affiliation: UNM OB Gyn
name: Eve Espey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.