Adjuvant Isonicotinic Acid Hydrazide (INH) With Misoprostol for Induction of Abortion in First-trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- number of patient with complete abortion
研究概览
简要总结
This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
详细描述
In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind randomized controlled study
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
- •previous one or more cesarean deliveries
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 INH.
研究组 & 干预措施
INH
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 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 two doses.
干预措施: Isonicotinic Acid (Drug)
INH
3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 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 two doses.
干预措施: Misoprostol (Drug)
Placebo Comparator
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
干预措施: Placebo (Drug)
Placebo Comparator
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
干预措施: Misoprostol (Drug)
结局指标
主要结局
number of patient with complete abortion
时间窗: 9 hours
number of patient with complete abortion
induction to abortion time
时间窗: 9 hours
induction to abortion time
次要结局
- number of patient need for surgical evacuation of the products of conception(12 hours)
研究者
hany farouk
A Professor
Aswan University Hospital