Presurgical orthopedics and satisfaction in motherhood: a randomized clinical trial (Dutchcleft).

OBJECTIVE: To study the effect of infant orthopedics on satisfaction in motherhood. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and was performed by means of a computerized balanced allocation method. Setting: Cleft palate centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands. PATIENTS: Two groups of infants with complete unilateral cleft lip and palate and no other malformations. INTERVENTIONS: Group IO+ (n = 27) wore passive maxillary plates during the first year of life, group IO- (n = 27) did not. MAIN OUTCOME MEASURE(S): Mean satisfaction scores were obtained from completed questionnaires at 6, 24, and 58 weeks of age. A 4-point scale was used (1 = very satisfactory to 4 = very unsatisfactory). RESULTS: The range of the mean scores for the individual items on the questionnaires for both groups ranged between 1.1 and 2.4. No differences were found between groups. Mothers appear to be satisfied in motherhood, least satisfied with the available time for themselves, and very satisfied with hugging and walking their babies. No differences were found between groups. CONCLUSIONS: Results from the present study show that infant orthopedics, with a passive plate during the first year of life, in children with a unilateral cleft lip and palate has no influence on the mothers' satisfaction in motherhood.