Clinical trial NCT01388582: The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Underweight
Keywords: contraceptives
hormonal
breastfeeding
infant weight
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-07-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* women at the day 42th of post-partum fully breastfeeding-

Exclusion Criteria:

* baby premature
* diabetes
* blood hypertension
* not breastfeeding or partial breastfeeding

Primary outcomes:
measure: Evaluation of infant weight, height and size of the tibial
timeFrame: women and children will be evaluated at time frame from day 42 through day 64 post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
Study officials:
affiliation: University of Campinas
name: Luis Bahamondes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.