Birth Control to Improve Birth Spacing: a Prospective Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,341
- 试验地点
- 2
- 主要终点
- Desired birth spacing
研究概览
简要总结
This study aims to investigate the drivers of postpartum contraceptive use with a prospective cohort. The study will clarify the role of contraceptive knowledge, attitudes, norms, and self-efficacy in driving intention to initiate contraception postpartum and describe the impact of environmental barriers on enacting intended postpartum contraception initiation.
详细描述
This study will be a sequential mixed-methods design with a prospective cohort to identify and explore barriers to contraceptive initiation both immediately after birth and prior to hospital discharge, as well as throughout the fourth trimester. It will include a baseline patient survey, electronic medical record data pull, follow up survey, and qualitative interviews.
The investigators will enroll 1400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at two sites. The baseline survey will be self-administered. The investigators will then contact participants for a follow-up survey at 12 weeks postpartum. Surveys will be self-administered through a link received by text message or email. Additional analyses will draw on retrospectively collected medical record data.
The investigators will invite a subset of 25-30 study subjects to participate in qualitative interviews.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 or older
- •Attending prenatal care visits at one of the two study sites
排除标准
- •Under the age of 18
- •Cannot complete a survey in English or Spanish
- •Do not have physical or cognitive ability to complete a survey on a tablet
结局指标
主要结局
Desired birth spacing
时间窗: Baseline
self-reported desire to space births
Contraceptive knowledge
时间窗: Baseline
measured via the Contraceptive Knowledge Assessment (Haynes et al 2017), 0-25 score range, higher scores reflect greater knowledge. Haynes MC, Ryan N, Saleh M, Winkel AF, Ades V. Contraceptive Knowledge Assessment: validity and reliability of a novel contraceptive research tool. Contraception. 2017 Feb;95(2):190-197. doi: 10.1016/j.contraception.2016.09.002. Epub 2016 Sep 9.
Contraceptive attitudes and norms
时间窗: Baseline
measured via validated psychometric scales; Examining Contraceptive Use and Unmet Need Study, 12-58 range, higher score indicates more knowledge, citation: Callegari, Lisa S., MD, MPH, Zhao, Xinhua, PhD, Schwarz, Eleanor Bimla, MD, MS, Rosenfeld, Elian, PhD, Mor, Maria K., PhD, \& Borrero, Sonya, MD, MS. (2017). Racial/ethnic differences in contraceptive preferences, beliefs, and self-efficacy among women veterans. American Journal of Obstetrics and Gynecology, 216(5), 504.e1-504.e10. DOI: 10.1016/j.ajog.2016.12.178
Planned postpartum contraceptive method
时间窗: Baseline
self-report of selected method
Intention to initiate contraception postpartum
时间窗: Baseline
self-reported desire to use contraception within 12 weeks of birth
Environmental barriers to contraceptive use
时间窗: 12-week follow up
Participants will rate the difficulty in accessing their desired contraceptive method after giving birth and respond to the reasons why it is - or is not - easy to access.
contraceptive self-efficacy
时间窗: Baseline
measured via validated psychometric scales; Examining Contraceptive Use and Unmet Need Study, 12-58 range, higher score indicates more knowledge, citation: Callegari, Lisa S., MD, MPH, Zhao, Xinhua, PhD, Schwarz, Eleanor Bimla, MD, MS, Rosenfeld, Elian, PhD, Mor, Maria K., PhD, \& Borrero, Sonya, MD, MS. (2017). Racial/ethnic differences in contraceptive preferences, beliefs, and self-efficacy among women veterans. American Journal of Obstetrics and Gynecology, 216(5), 504.e1-504.e10. DOI: 10.1016/j.ajog.2016.12.178
Contraceptive use
时间窗: 12-week follow up
Participants will be asked if they have used a contraceptive method since giving birth.
次要结局
- Intimate partner violence(12-week follow up)
研究者
Elizabeth Janiak
Assistant Professor
Brigham and Women's Hospital