Ultrasonographic and Hormonal Characteristics of Malawian Women With and Without Obstetric Fistula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Cervical length
研究概览
简要总结
This study is a cross-sectional study of 110 Malawian women to compare the ultrasonographic and hormonal characteristics of women and without obstetric fistula.
Hypothesis #1: Women with obstetric fistula have a mean cervical length measurement that is at least 10 mm shorter than the mean cervical length measurement of similar women without obstetric fistula.
Hypothesis #2: Evaluation of the hormonal and ultrasonographic characteristics of women with obstetric fistula will allow us to assess the cause of amenorrhea in these women.
详细描述
This study is a cross-sectional study of 110 Malawian women who present for medical evaluation at the Fistula Care Centre in Lilongwe, Malawi. If a woman enrolls in the study, her demographic, medical history, physical exam, and lab data will be abstracted from her medical records at the Fistula Centre. She will also a pelvic ultrasound on each participant so that the characteristics of her cervix, uterus, and ovaries (such as the cervical length, endometrial thickness and ovarian volume) can be evaluated. If the participant has an obstetric fistula, she will also complete an additional blood draw for lab testing. The laboratory tests will evaluate three hormones that are associated with amenorrhea and infertility: follicle stimulating hormone, estradiol, and antimullerian hormone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Presentation to the Fistula Care Centre in Lilongwe for medical evaluation
- •Ability to consent for study participation in Chichewa
- •Female aged 18-45 years
- •Willingness to undergo pelvic ultrasound for assessment of pelvic organs
排除标准
- •No history of pregnancy
- •History of hysterectomy
- •Current pregnancy or pregnancy within the past six weeks
- •Seriously or terminally ill
结局指标
主要结局
Cervical length
时间窗: baseline
次要结局
- Hormonal levels(baseline)
研究者
Jennifer Tang, MD, MSCR
Research Assistant Professor
University of North Carolina, Chapel Hill