The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
Condition: Underweight
MeSH terms: Thinness
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a
      etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the
      provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight
      of the mother will be administer to all women. One sample of saliva from the mother and the
      child will be collected every day until 21 days after enrollment. Additionally, weight,
      height and size of the leg of each child will be measured at baseline, at the day 11 and at
      the day 21 after enrollment. Also, a diary with information of change of diapers and number
      of breastfeeding will be kept by each mother.
    

Intervention name(s): LNG-IUS; Implanon; 30 mcg EE and 150 LNG oral contraceptive (Microvlar); TCu380A copper-intrauterine device; TCu380A intrauterine device
Intervention type(s): Device; Device; Drug; Device; Device
Intervention description(s): 10 women will receive the LNG-IUS during breastfeeding; 60 mcg/day contraceptive implant; 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
Other intervention name(s): Mirena, Bayer, Brazil; Implanon, MSD, Brazil; Microvlar (Bayer, Brazil); Optima IUD (Injeflex, Brazil); Implanon, MSD, Os, The Netherland; Mirena, Bayer Oy, Tuku, Finland; TCu380A copper intrauterine device; Optima, Injeflex, Brazil; Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Intervention MeSH terms: Copper; Contraceptive Agents; Levonorgestrel; Etonogestrel; Desogestrel; Contraceptives, Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: contraceptives; hormonal; breastfeeding; infant weight