Efficacy of addition of vaginal Dinoprostone gel(PGE2) to the mifepristone-misoprostol regimen for the second trimester termination of pregnancy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
研究概览
简要总结
All patients who meet eligibility for inclusion in the study will be approached for enrollment during either OPD visit or in the labor oom. If a patient is willing to participate in the study , enrollment in the study will be noted in the case record form. Written informed consent will be obtained from all study participants.Sealed envelopes will be used to randomly allocate groups to paticipants. Group A will receive routine Mifepristone 200 mg per orally followed by per vaginal examination at 30 hours followed by Misoprostol 400 mcg at 36 hours interval every 3 hourly for a maximum of 5 doses. Intervention group will also receive initially 200 mg Mifepristone followed 30 hours by 0.5 mg Dinoprostone gel vaginally followed by 400 mcg misoprostol every 3 hourly (max 5 doses) after 6 hours of dinoprostone gel application. During each dose adminstration , women’s vital signs will be monitored every 2 hourly and process of abortion will be assessed by vaginal examination every 4 houry. After the completion of abortion, the products of conception will be checked for its completeness and induction-abortion interval will be calculated and noted. If theabortion will be still incomplete , it will be completed using surgical evacuation. After the completion of abortion , patients will be observed for 24 hours before discharge and failure of abortion will be considered when a woman failed to abort within 15 hours of 1st dose of misoprostol.For failed cases ,other methods of termination will be undertaken.On discharge ,they will be asked for follow up after a week or earlier in emergent cases. On follow up cases , pelvic examination will be performed and an inquiry will be made of any abnormal bleeding or delayed sode effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women with 12-24 weeks POG elih=gible for second trimester termination of pregnancy as per MTP act.
- •Women with fetal demise between 12-24 weeks Signed informed consent to participate in the study.
排除标准
- •Women who refuse to give consent for this study.
- •Women with multiple pregnancies.
- •Women with previous Cesarean section.
- •Women with a certain degree of cervical dilatation.
- •Women with allergy or contraindication to either drug Those who have some contraindication to either drug.
研究者
Dr Anjali Kumari
Aiims Jodhpur
