The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth

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.

Conditions

• Underweight

Interventions

DEVICE

LNG-IUS

10 women will receive the LNG-IUS during breastfeeding

DEVICE

Implanon

60 mcg/day contraceptive implant

DRUG

30 mcg EE and 150 LNG oral contraceptive (Microvlar)

10 women will receive oral contraceptive during breastfeeding

DEVICE

TCu380A copper-intrauterine device

Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group

DEVICE

TCu380A intrauterine device

10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• University of Campinas, Brazil

  lead OTHER

Principal Investigators

• Luis Bahamondes, MD · University of Campinas

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2011-08-31

Completion

2011-08-31

Countries

• Brazil

Study Locations