Oral Mifepristone and Buccal Misoprostol Administered Simultaneously for Abortion Through 63 Days Gestation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To determine the complete abortion rate, at 24 hours after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg buccally simultaneously in women at <49, 50-56, and 57-63 days gestation.
研究概览
简要总结
HYPOTHESIS: For women with pregnancies at <49, 50-56, and 57-63 days gestation who receive mifepristone 200 mg orally and misoprostol 800 mcg buccally at the same time, the complete abortion rate 24 hours after misoprostol administration will be 90% (95% CI 78%, 97%) within each gestational age group.
This is a prospective clinical trial. Women will be enrolled such that 40 women are in each of three gestational age ranges: ≤49, 50-56, and 57-63 days gestation on the day treatment is initiated. Once a gestational age range includes 40 subjects, enrollment in that group will be closed. Subjects will swallow mifepristone 200 mg and then place four 200 µg misoprostol tablets between the check and gum (2 tablets on each side). The women will be instructed to keep the tablets in place for 30 minutes; any remaining portions of the tablets will be swallowed after this time. Participants will follow-up 24 hours after receiving the misoprostol. Vaginal ultrasonography will be performed to assess for expulsion of the gestational sac. Women who have not aborted by the first follow-up visit will be given a dose of vaginal misoprostol and will return for a follow-up visit in one week. Subjects who have not aborted by the two-week follow-up will be offered a surgical abortion. At each visit, data will be collected on bleeding, cramping, other side effects, and medication use.
详细描述
- TELEPHONE SCREEN:
Initial contact will be by a phone call (or, rarely, a drop-in visit) initiated by a potential study participant. A member of the research staff will advise the potential participant of the study rationale, protocol, risks, benefits, and visit schedule. We request a waiver of the requirement to obtain signed informed consent for the screening process, which will usually take place over the phone. We believe we meet the criteria for the use of this waiver because the screening procedure presents no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context. The information obtained during the screening phone call is the same type of information that would be collected on patients setting up an appointment for an abortion. The telephone script and screen are included in Attachment 2. If the subject does not meet inclusion criteria, the information collected during the screening process will be destroyed. Potential subjects interested in participation will be scheduled for a screening visit.
Each subject will undergo a minimum of 3 visits all of which will be performed in the Family Planning Research Office at Magee-Womens Hospital. She will also receive a minimum of 3 follow-up telephone calls. Those subjects who do not pass the pregnancy by the first follow-up visit will be scheduled for return visits as indicated on the Study Flow Sheet (see attachment) and described below. 2. SCREENING AND ENROLLMENT: Visit length 1 ½ hours.
- After obtaining consent for a screening ultrasound evaluation, a transvaginal and a transabdominal ultrasound examination will be performed to ascertain gestational age. The transvaginal ultrasound results will be used to confirm gestational age and document an intrauterine gestation for the study protocol. Vaginal ultrasound to confirm estimated gestational age (EGA) will use the following criteria:
- EGA (days) = mean sac diameter + 3025
- EGA (days) = embryonic pole + 4226
- Mean sac diameter ([length + width + depth]/3) should be used only when no embryonic pole is present.
- If the ultrasound EGA is different from LMP EGA by 4 days or more, then the ultrasound EGA should be used as the study EGA.
- Written informed consent will be obtained at the screening visit prior to any research activities. The investigator or one of the co-investigators, who are physicians, will sign the informed consent document.
- After obtaining informed consent, a medical history and initial laboratory tests (hemoglobin and blood type) will be obtained. If the pelvic examination is normal, the endovaginal ultrasound confirms that the gestational age will be less than 63 days on the day of the mifepristone administration, and the laboratory tests satisfy the entry criteria, the subject will be asked to participate in the study.
- A HIPAA compliant "Release of Medical Records" form will be signed to allow future access to medical records related to any care provided during the study by another health care provider.
- VISIT 1: The subject will return prior to reaching 64 days gestation. This day will be considered Study Day 1. Visit length 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Healthy females: 1) 18 years of age or older, 2) requesting an elective termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more than 63 days gestation on the day of mifepristone administration as documented by endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if indicated, and 7) with easy and ready access to a telephone.
排除标准
- •ultrasound evidence at the evaluation(s) prior to mifepristone treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy to mifepristone, chronic corticosteroid administration, adrenal disease), 3) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7) known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report, 14) prior participation in this research study, or 15) current participation in another research study that, in the opinion of the investigator, would interfere with the conduct of this study.
结局指标
主要结局
To determine the complete abortion rate, at 24 hours after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg buccally simultaneously in women at <49, 50-56, and 57-63 days gestation.
次要结局
- To compare the complete abortion rates, at 24 hours after misoprostol administration, by gestational age (up to and including 49, from 50-56, and 57-63 days gestation) with this medical abortion regimen.
- To determine the complete medical abortion rate at approximately 14 days after treatment, among those women who receive a second dose of misoprostol.
- To assess side effects (i.e. nausea, vomiting) and pain medication use after treatment.
- To assess the acceptability of this medical abortion regimen.
- To compare the accuracy of transvaginal and abdominal ultrasonography in gestational age dating and treatment failure in this cohort.