[T.O.M. ointment, breast feeding and serum estradiol in newborn infants. A double-blind, randomized controlled study].
OBJECTIVE
To study whether there is an iatrogenic transfer of oestradiol through the use of T.O.M. ointment administered to prevent or to cure trophic changes in the breast while breastfeeding and what the dangers of plasma levels of oestradiol in the newborn will be.


METHODS
Controlled, randomised, double blind.


METHODS
80 mother/infant couples were included in the study: 40 received the ointment containing oestradiol (the treated group), and 40 received an ointment without oestradiol (the non-treated group); the ointment was applied before each breastfeeding from the 2nd to the 6th or 7th day of life. Mothers' milk and blood from the newborn babies were taken for estimating the levels of oestradiol using a radio-immunological technique. The total quantity of ointment was measured for each subject.


RESULTS
The mean level of oestradiol in the treated mothers' milk was significantly higher (p. 0.0014) than in the milk of the mothers who had not been treated. The concentration of oestradiol in the plasma of the newborn dropped from the first to the last day of the trial without any difference in the treated or non-treated groups no matter what the sex of the child was, nor the quantity of ointment used.
Boutroy
M J
MJ
INSERM U 272 et Service de Gynécologie-Obstétrique C, Maternité Regionale Universitaire, Nancy.
Nicolas
A
A
Curien
B
B
Barbarino-Monnier
P
P
Boutroy
J L
JL
D001941:Breast Diseases / Q000517:prevention & control; D001942:Breast Feeding; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000032:analysis / Q000097:blood* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008895:Milk, Human / Q000737:chemistry*; D009824:Ointments; D010349:Patient Compliance; D011446:Prospective Studies; D013997:Time Factors
D009824:Ointments; D004958:Estradiol; C010452:estradiol-17 beta-benzoate
Pommade T.O.M., allaitement et estradiolémie des nouveau-nés, Etude contrôlée, randomisée, à double insu.