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临床试验/NCT00677742
NCT00677742已完成不适用

Impact of Pack Supply on Oral Contraception Continuation

Columbia University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
700
试验地点
1
主要终点
oral contraception continuation

研究概览

简要总结

The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.

详细描述

Discontinuation of oral contraceptive use in the initial months is common; successful early continuation is predictive of long term continuation and prevention of unintended pregnancy. The conventional approach to initiation of hormonal contraceptives in publicly funded clinics across the United States is to give the patient a limited supply of OCs, or a prescription with a limited number of refills, and then have her return to the clinic for a refill. This approach requires the patient to make frequent visits to the clinic, a barrier to method continuation.

This randomized trial will evaluate a simple but potentially powerful change in family planning clinic practice, i.e., the effect of dispensing more versus fewer cycles of oral contraception (OC). The study will be carried out in an urban, publicly funded family planning clinic that serves a population that is poor, young and primarily Hispanic or AfricanAmerican. This population was targeted as its members are at increased risk of discontinuing contraception in the first year of use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
— 至 35 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • English or Spanish speaker
  • age less than or equal to 35 years requesting OC as their primary method of contraception
  • currently sexually active or anticipating sexual activity within the next 30 days

排除标准

  • contraindications to oral contraceptives per clinic protocol (e.g., hypertension and pregnancy)
  • currently using OCs (that is, current users requesting a routine refill)
  • desiring pregnancy within the next 6 months
  • leaving the clinic catchment area within 6 months
  • previous participation in this study

结局指标

主要结局

oral contraception continuation

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn L. Westhoff

Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center

Columbia University

研究点 (1)

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