Misoprostol for the Medical Management of Non-Viable First Trimester Pregnancies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- time to resolution
研究概览
简要总结
The purpose of this study is to examine the effectiveness of Misoprostol (Cytotec; GD Searle and Co., Chicago, IL) for the management of non-viable first trimester pregnancies. Specifically, Misoprostol (15-S-15-methyl PGE1) will be compared to a placebo with expectant management in who have documented non-viable gestations. We will examine the following outcome variables: time to resolution, number of patients requiring dilation and curettage, change in hematocrit, cost to the institution, patient satisfaction, and reported side effects.
详细描述
Patients presenting to the OB/GYN clinic with a nonviable gestation, diagnosis documented by endovaginal ultrasound will be enrolled. Ultrasonic findings will be verified by two of the resident staff from the obstetrics and gynecology department of Madigan Army Medical Center. Patients consenting will be directed to the OB/GYN clinic for evaluation, exam, and counseling and to watch the video giving explanation of purpose of the study and the planned procedure, but also expected side effects and possible complications. Patients will be randomized into two groups: study group receiving Misoprostol per vagina and the control group receiving a placebo per vagina. Subjects will be issued an envelope and go to the pharmacy to pick up their study medication, blinded to them and the provider. They will also be given Motrin and Phenergan to help alleviate undesired side effects. Four 200 ug tablets of Misoprostol or placebo will be placed in the posterior fornix of the vagina using a speculum under the direct visualization of the provider. Patients will return in 24 hours for re-examination. If no evidence of an intrauterine pregnancy remains, patients will be informed that their miscarriage was complete, given precautions and asked to make an appointment for follow-up in 4 weeks in addition to weekly visits to the lab for quantitative BHCG. All patients will be followed until the quantitative BHCG has fallen zero to ensure resolution of the pregnancy event.
Patients with evidence of a gestational sac will be given a second dose of Misoprostol or a D&C if they choose to withdraw from the study or a surgical intervention if it is deemed clinically indicated by the attending staff. Again, subjects will be given appropriate counseling and precautions and asked to follow up in an additional 24 hours for re-evaluation. Surveys will be given at each visit and follow up to evaluate patient satisfaction and also to query for unintended side effects and complications.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients with nonviable pregnancy document by ultrasound
- •Gestation at or less than 13 weeks by ultrasound measurements
- •Clinically stable as determined by provider
- •Hematocrit > 30
- •Over 18 years of age
排除标准
- •History of allergy to, or intolerance of, misoprostol
- •Refusal to abstain from intercourse for 72 hours
- •Significant vaginal bleeding (> 2 pad/hr)
- •History of inflammatory bowel disease
研究组 & 干预措施
A
Four 200 ug tablets of Misoprostol
干预措施: Misoprostol (Drug)
B
干预措施: Misoprostol (Drug)
结局指标
主要结局
time to resolution
时间窗: 24hrs, and then weekly, after insertion
percentage requiring dilation and curettage
时间窗: 24hrs, and then weekly, after insertion
failure to expel products of conception
时间窗: 24hrs, and then weekly, after insertion
change in hematocrit
时间窗: 24hrs, and then weekly, after insertion
side effects
时间窗: 24hrs, and then weekly, after insertion
BHCG level
时间窗: 24hrs, and then weekly, after insertion
次要结局
未报告次要终点
