Adjuvant Isonicotinic Acid Hydrazide (INH) Pretreatment With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- number of patients with complete abortion
研究概览
简要总结
The primary endpoint was the success rate of adjuvant isonicotinic acid hydrazide (INH) and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.
详细描述
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 10 weeks based on the last menstrual period
Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week
Adjuvant isonicotinic acid hydrazide (INH) administration with misoprostol raises the rate of complete abortion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind randomized parallel assign controlled trial
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
- •Gestational age less than 70 days gestation (<10 wks)
- •Hemoglobin >10 g/dL.
- •BMI between 18.5 kg/m2 and 30 kg/m
- •Missed abortion
排除标准
- •Molar pregnancy.
- •Fibroid uterus.
- •Uterine anomalies.
- •Coagulopathy.
- •Medical disorder that contraindicate induction of abortion (e.g. heart failure).
- •Previous attempts for induction of abortion in the current pregnancy.
- •Allergy to misoprostol or letrozole.
- •Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
研究组 & 干预措施
INH
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.
干预措施: Isonicotinic Acid Hydrazide (Drug)
INH
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.
干预措施: Misoprostol (Drug)
Misoprostol
Misoprostol Alone 800 mcg every three hours up to maximum three doses
干预措施: Misoprostol (Drug)
结局指标
主要结局
number of patients with complete abortion
时间窗: 12 hours
number of patients with complete abortion
time from induction to abortion
时间窗: 12 hours
time from induction to abortion
次要结局
- number of the women will undergo dilatation and curettage after failed medical induction of abortion(12 hours)
研究者
hany farouk
A Professor
Aswan University Hospital