Sample Composition With Time, According to Treatment

Treatment GroupTotal
No. of eligible patients invited to participate1290
No. of refusals151
No. of randomized1139
No. allocated to treatment1665152302281139
No. of postrandomization drops*144413
Average no. of completed prenatal home visits (range, SD)7 (0–18, 4.0)7 (0–18, 4.0)14
Average no. of completed postnatal home visits (range, SD)26 (0–71, 14.7)26
No. of miscarriages6196839
No. of stillbirths053210
No. of infant/child deaths272112
No. available for follow-upNA480NA213693
No. of 6-y maternal interviews completedNA444NA197641
No. of 6-y child assessments completedNA425NA190615
  • Unless otherwise specified, the difference between the numbers of cases randomized and assessed is attributable to missed assessments. NA indicates not applicable.

  • * Eleven of the 13 women who dropped out involved cases in which the mother refused participation after randomization. One case (assigned to treatment 2) was dropped from the study when it was learned that the woman was registered and randomized a second time after an earlier registration and miscarriage; a second case (assigned to treatment 1) was not monitored because of a clerical error after a staff member identified the woman as not meeting the inclusion criteria.