Feasibility of Home Follow-up After Medication Abortion (MAB)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Completed follow-up for the clinic group
研究概览
简要总结
This study aims to evaluate a home follow-up alternative after medication abortion with pregnancy testing and a completion test. Clinical evaluation after a medication abortion (MAB) is standard of care to diagnose continued pregnancy and treat complications, typically done with a provider and an ultrasound examination or serial blood testing. Follow-up rates in the literature after MAB have been found to be 51% to 77% in recent literature using these standard follow-up methods. Though medication abortion is highly efficient, the on-going pregnancy rate is about 4% for pregnancies with gestational age up to 70 days from last menstrual period, thus highlighting the importance of follow-up as patients may not know they have a continued pregnancy weeks to even months after taking medication for an abortion. The investigators plan on providing participants with the option of a home follow-up option versus the standard of care (clinic) option. The primary objective of this study is looking at follow-up rates by each of these groups. As more options are provided for follow-up to patients, it is hoped that follow-up rates will improve and reduce the burdens of clinic visits on both providers and patients, ultimately making continued pregnancy after a medication abortion a never event.
详细描述
The primary objective of this research is to determine if introducing home follow-up will improve follow-up rates after medication abortion
Secondary objectives of the study are to:
- assess the feasibility of mobile phone text messaging with low sensitivity pregnancy testing for home follow-up after medication abortion
- assess the acceptability of chosen follow-up after medication abortion
- determine the complication rate, emergency room visit rate, and ongoing pregnancy rate after home follow-up
This prospective cohort study will be carried out at a single, urban hospital-based abortion clinic exploring the feasibility and acceptability of home follow-up after medication abortion with text messaging and a Low Sensitivity Pregnancy Test (LSPT). Participants will be recruited from a single abortion practice at Boston Medical Center (BMC) in Boston, Massachusetts. This clinic serves a multi-ethnic population from the South Boston area, with most patients English and Spanish speaking and covered by public insurance. Abortion care is provided by obstetrics and gynecology residents, family planning fellows, nurse practitioners, and family planning doctors.
As part of the study participants will be given the choice to have clinic follow-up or home follow-up. The clinic follow-up cohort will receive our clinic standard of care - they will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination. This cohort will be asked the same questions to assess completion that will be asked of the home follow-up group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English or Spanish speakers
- •Have a working phone they consider their own with text messaging capabilities
- •Have a viable intrauterine pregnancy
- •Are eligible for a medication abortion (10 weeks gestational age or less)
- •Elect the method of medication abortion
排除标准
- 未提供
结局指标
主要结局
Completed follow-up for the clinic group
时间窗: 2 weeks
Percent of participants in this group that return to the scheduled clinic visit
Completed follow-up for the home group
时间窗: 2 weeks
Percent of participants in this group that completed the final texted survey
次要结局
- Complications after the medical abortion(42 days)
- Number of emergency visits(42 days)
- Any follow up(42 days)
- Ongoing pregnancy(42 days)
- Screen positive for pregnancy in the home follow-up group(2 weeks)
- Acceptability of chosen follow-up(2 weeks)