Lactation Clinical Trial
Objective: To determine and compare the effect of low dose estrogen combined hormonal
contraceptives and progestin-only contraceptives on lactation.
The subjects will be drawn from a healthy obstetric population in each center, where
possible preliminary contact during antenatal period. At the postpartum visit, subjects that
express their wish for a hormonal contraceptive method will be offered enrollment. After
obtaining an informed consent the participants will be allocated according to their free
wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg
desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel
(Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to
analysis.
Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12
weeks post - partum. Instruction will be given as to recording information on intercurrent
disease, frequency of nursing and use of complementary formula supplements. Maternal BMI
calculation ( weight/height2) will be obtained at first visit.
The objective is to compare the capacity of the breast to secrete milk under standard
conditions and evaluate the influence of different hormonal contraception means. Thus
samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell
pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular
breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest
will be offered to the infant. The milk volume/feeding will be estimated and expressed in
ml/feeding and multiplied by the number of feedings reported.
Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk
analysis : lipid, casein and carbohydrate content
n/a
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