A Randomized Controlled Trial of Three Prophylactic Antibiotic Regimens for First Trimester Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Nausea Scale
研究概览
简要总结
This study, a double blinded randomized controlled trial, is being done to compare side effects of commonly used antibiotic regimens prior to same day abortion procedures.
In total, 180 pregnant women in their first trimester of pregnancy (5 0/6-13 6/7 weeks gestation) will be randomized to receive one of the three commonly used antibiotics (azithromycin, doxycycline, metronidazole) for same day abortion procedures or placebo prior to their abortion procedure. Approximately, 30-60 mins after study drug administration, the procedure will be performed.
A sub-study will be completed on 40 women who consent to endometrial sampling and to have their blood drawn.
详细描述
Main Study:
Women will be randomized to receive single oral doses of azithromycin 500 mg, doxycycline 200 mg, metronidazole 500 mg, or placebo. Computer-generated randomization will be used to assign participants to one of the four treatment arms. Women receiving placebo will receive antibiotic prophylaxis after completion of the study.
Both the participants and the investigators will be blinded as to the treatment group. This will be accomplished by placing the study medication inside opaque gelatin capsules. We will randomize participants by assigning them to the next of the sequentially numbered sealed opaque study packets, containing the gelatin capsules with study medication inside. A second envelope will be opened after completion of all study procedure and will only say if the participant received placebo, so that additional antibiotics can be given.
Participants will swallow the appropriate medication approximately 30-60 minutes prior to the surgical abortion (15-90 minutes range is acceptable). Study population will be all eligible patients undergoing surgical abortion in the first trimester at Washington Hospital Center and Planned Parenthood Metropolitan Washington. We will assess pain and side effects via written questionnaire at three different time points throughout the day, once at time of consent, before and after the procedure. Patients will be contacted within 1-2 weeks for follow-up and again pain and side effects will be assessed, as well.
Sub-study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women in good general health.
- •English speaking.
- •Age 18 or over.
- •Seeking non-urgent surgical termination of pregnancy.
- •Gestational age of 5 0/7 to 13 6/7 weeks, confirmed by sonogram.
排除标准
- •Less than 18 years of age.
- •Early pregnancy failure or fetal demise.
- •Poor general health that would prevent one from tolerating the medication or surgical procedure.
- •Intolerance, allergy, or contraindication to any of the study medications.
- •Inability to tolerate oral intake due to current nausea or vomiting.
- •Diagnosis of hyperemesis gravidarum with current pregnancy.
- •Need of an urgent surgical abortion.
- •Gestational age outside of 5-13 6/7 weeks by sonogram.
研究组 & 干预措施
Azithromycin
500 mg of Azithromycin
干预措施: Azithromycin (Drug)
Doxycycline
200 mg of Doxycycline
干预措施: Doxycycline (Drug)
Metronidazole
500 mg of Metronidazole
干预措施: Metronidazole (Drug)
Placebo
Inactive Ingredient
干预措施: Placebo (Drug)
结局指标
主要结局
Nausea Scale
时间窗: 1 Day
Nausea symptom was collected at different time points via surveys (None, Mild, Moderate, Severe)
Emesis Severity
时间窗: 1 Day
Emesis severity assessment collected at different time points (None, Mild, Moderate, Severe)
次要结局
- Serum Antibiotic Levels(3 hours)
- Pain Scale(Day 1)
- Endometrial Growth(3 Days)