The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women
1 other identifier
interventional
40
1 country
1
Brief Summary
The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
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
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedMay 17, 2012
May 1, 2012
4 months
June 16, 2011
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of infant weight, height and size of the tibial
The study have the purpose to evaluate the infant weight, height and size of the tibial in infant who breastfeeding on demand exclusively and their mother were either users of a combined oral contraceptive, placebo, etonogestrel-releasing subdermal contraceptive implant or levonorgestrel-releasing intrauterine system. Additionally, pregnancy effectiveness and any adversse event will record in all groups of women.
women and children will be evaluated at time frame from day 42 through day 64 post-partum
Study Arms (4)
Combined oral contraceptive
ACTIVE COMPARATOR10 women will receive COC during breastfeeding
Levonorgestrel intrauterine system
ACTIVE COMPARATOR10 women will receive a LNG-IUS during breastfeeding
Implanon
ACTIVE COMPARATOR10 women will receive Implanon during breastfeeding
TCu380A intrauterine device
ACTIVE COMPARATOR10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding
Interventions
10 women will receive the LNG-IUS during breastfeeding
10 women will receive oral contraceptive during breastfeeding
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Eligibility Criteria
You may qualify if:
- women at the day 42th of post-partum fully breastfeeding-
You may not qualify if:
- baby premature
- diabetes
- blood hypertension
- not breastfeeding or partial breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campinas
Campinas, São Paulo, 13083-888, Brazil
Related Publications (1)
Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhaes A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Aug;100(2):445-50. doi: 10.1016/j.fertnstert.2013.03.039. Epub 2013 Apr 23.
PMID: 23623474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Bahamondes, MD
University of Campinas
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Medical Doctor
Study Record Dates
First Submitted
June 16, 2011
First Posted
July 6, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
May 17, 2012
Record last verified: 2012-05