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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Underweight

Intervention / Treatment
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* Device: LNG-IUS
* Device: Implanon
* Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
* Device: TCu380A copper-intrauterine device
* Device: TCu380A intrauterine device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women at the day 42th of post-partum fully breastfeeding- Exclusion Criteria: baby premature diabetes blood hypertension not breastfeeding or partial breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined oral contraceptive<br>10 women will receive COC during breastfeeding | Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar)<br>* 10 women will receive oral contraceptive during breastfeeding<br>* Other names: Microvlar (Bayer, Brazil);Device: TCu380A intrauterine device<br>* 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding<br>* Other names: Microvlar oral contraceptive, Bayer, São Paulo, Brazil;|
| Active Comparator: Levonorgestrel intrauterine system<br>10 women will receive a LNG-IUS during breastfeeding | Device: LNG-IUS<br>* 10 women will receive the LNG-IUS during breastfeeding<br>* Other names: Mirena, Bayer, Brazil;Device: TCu380A intrauterine device<br>* 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding<br>* Other names: Microvlar oral contraceptive, Bayer, São Paulo, Brazil;|
| Active Comparator: Implanon<br>10 women will receive Implanon during breastfeeding | Device: Implanon<br>* 60 mcg/day contraceptive implant<br>* Other names: Implanon, MSD, Brazil;Device: TCu380A intrauterine device<br>* 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding<br>* Other names: Microvlar oral contraceptive, Bayer, São Paulo, Brazil;|
| Active Comparator: TCu380A intrauterine device<br>10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding | Device: TCu380A copper-intrauterine device<br>* Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group<br>* Other names: Optima IUD (Injeflex, Brazil);Device: TCu380A intrauterine device<br>* 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding<br>* Other names: Microvlar oral contraceptive, Bayer, São Paulo, Brazil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptives, hormonal, breastfeeding, infant weight