A NOVEL ORAL CONTRACEPTIVE INITIATION METHOD

Columbia University Health Sciences, New York NY

Investigators

Linked publications & trials

Abstract

DESCRIPTION (Adapted from applicant's description): In the United States, nearly half of all pregnancies are unintended at the time of conception, and more than eighty percent of pregnancies among teenagers are unintended. The main reason is non-use of effective contraceptives. Oral contraceptives are one of the most effective of methods, but even after they are prescribed, pregnancy rates remain high. This is primarily related to non-use of the pills (encompassing both discontinuation and never starting). As many as 24% of young women who seek oral contraceptives never start them. Because conventional instructions for starting oral contraceptives mandate waiting for the next menstrual period, never starting may occur due to waning motivation or to pregnancy that occurs before the next period. The proposed study is a pilot evaluation designed to produce sample size, subject enrollment and retention, and budget estimates needed for a large randomized trial to compare the conventional oral contraceptive initiation method to an innovative approach called Quickstart. With this innovative approach, a woman begins taking oral contraceptives at any time during her menstrual cycle when she is motivated to begin contraception. In the planned randomized trial, contraceptive continuation and discontinuation, associated bleeding patterns, and unintended pregnancies will be compared between the two groups. This pilot study will be a one year effort to produce estimates of enrollment, losses to follow-up, and occurrence of pertinent outcomes, including pregnancy and contraceptive discontinuation. This pilot will also assess the effects of three different levels of patient incentives to enroll and complete the follow-up interview. These data will then be used to estimate sample size, power and budget for the larger randomized trial to follow.