Underweight
Conditions
Keywords
contraceptives, hormonal, breastfeeding, infant weight
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.
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.
Interventions
DEVICELNG-IUS
10 women will receive the LNG-IUS during breastfeeding
DEVICEImplanon
60 mcg/day contraceptive implant
DRUG30 mcg EE and 150 LNG oral contraceptive (Microvlar)
10 women will receive oral contraceptive during breastfeeding
DEVICETCu380A copper-intrauterine device
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
DEVICETCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* women at the day 42th of post-partum fully breastfeeding-
Exclusion criteria
* baby premature * diabetes * blood hypertension * not breastfeeding or partial breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of infant weight, height and size of the tibial | women and children will be evaluated at time frame from day 42 through day 64 post-partum | 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. |
Countries
Brazil
Outcome results
None listed