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临床试验/NCT00068848
NCT00068848已完成4 期

RCT of a Novel Oral Contraceptive Initiation Method

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)5 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2003年2月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
2,000
试验地点
5

研究概览

简要总结

Women who choose to take birth control pills are currently instructed to begin taking the pills at the end of a menstrual cycle. This creates a window of time between when the woman is given the pills and when she begins taking them. Some women fail to begin taking the pills, placing them at increased risk of pregnancy. This study will evaluate a new approach to beginning birth control pills. Women will take the first pill in the doctor's office rather than waiting until the next menstrual cycle.

详细描述

Despite the effectiveness of oral contraceptives, pregnancy rates are high among women who choose this method of birth control. These pregnancies occur due to incorrect use, premature discontinuation, and failure to begin taking oral contraceptives after they have been prescribed. As many as 25% of adolescents who seek oral contraceptives from family planning clinics never take the first pill. Failure to begin oral contraceptives may occur due to ambivalence, confusion about starting instructions, or intervening pregnancy. Conventional starting instructions for oral contraceptives require waiting until the next menstrual period; this may leave the woman at high risk of pregnancy. This trial will evaluate a "quick start" approach in which the woman swallows the first pill during the clinic visit under direct observation and then continues daily pill use without waiting for her next menses. The trial will determine whether immediate oral contraceptive initiation offers benefits compared to conventional starting approaches.

Participants in this study will be randomized to receive either the quick start or the standard starting approach. Participants will complete a questionnaire at study entry and Months 3 and 6. The main outcomes are 6-month oral contraceptive continuation rates and pregnancy rates.

研究设计

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

入排标准

年龄范围
— 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Requests hormonal contraceptives as primary method of contraception
  • Sexually active (intercourse within 30 days prior to study entry) or anticipating sexual activity within 30 days following study entry

排除标准

  • 未提供

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (5)

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