The Importance of Including Reproductive Life Plan Counseling During Contraceptive Counseling: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Awareness of preconception health
研究概览
简要总结
The reproductive life plan is a protocol intended to promote preconception planning, improve reproductive health and increase health knowledge. The aim of the study is to evaluate the importance of including the reproductive life plan counseling during contraceptive counseling.
详细描述
The aim of the study is to evaluate the outcomes of the reproductive life plan counseling on knowledge about fertility and awareness of preconception health.
2 groups of women visiting a primary health care center for contraceptive counseling are formed: a control group that will receive the standard care (standard family planning counseling) and the intervention group that will receive the standard family planning counseling in addition to the reproductive life plan counseling.
The included women are aged between 20 and 40 years. They are informed about the study when they call the center to make their appointment. When they attend the center, they receive a written and oral information and they are also informed that participation is voluntary and that they can interrupt their participation at any time without explanation. The women who agree to participate will sign an informed consent.
The midwives will be trained to reproductive life plan counseling before the commencement of the study. They have access to a template with discussion points to choose from, depending on the woman's answer to the first question (Do you want children/more children in the future?). If the answer is "no" the counseling will focus on contraceptive methods and sexual health (avoiding sexually transmitted diseases). If the answer is "yes" the discussion will focus on preconception and reproductive health (avoiding alcohol and tobacco, taking folic acid at least one month before conception, avoiding under and overweight,...).
Randomization: sealed envelopes are prepared with notes for CG (control group) or IG (intervention group). Before starting the counseling, the midwife opens the envelope containing instructions for either CG or IG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 20 and 40 years old visiting the health center
排除标准
- •Women that refuse to participate in the study
结局指标
主要结局
Awareness of preconception health
时间窗: 2 months
Unit of measure: The percentage of women who answer correctly the questions about preconception health. Measurement tool: Questionnaire using the following questions (the importance for a woman to stop using tobacco, to refrain from alcohol, to be of normal weight, and to start with folic acid before a pregnancy). This outcome is compared between the intervention group and the control group.
Knowledge about fertility
时间窗: 2 months
Unit of measure: The percentage of women who answer correctly the questions about fertility. Measurement tool: Questionnaire using the following questions (probability of a 25-year-old woman becoming pregnant if she had unprotected intercourse, fecundity time of an ovum, the age of decline of woman's fertility, the chance of giving birth after in-vitro fertilization). This outcome is compared between the intervention group and the control group.
次要结局
- The use of contraception(2 months)
