跳至主要内容
临床试验/CTRI/2024/07/070965
CTRI/2024/07/070965招募中不适用

Comparison between Letrozole and Mifepristone as pre-treatment in medical management of early pregnancy termination: a prospective open-label randomized controlled trial.

Sanchari Debnath1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Complete evacuation of conceptus

研究概览

简要总结

Miscarriage is a common early pregnancy complication that occurs in 15% to 20% of all clinical pregnancies, and the majority occur in the first trimester. According to FIGO guideline, the typical dosage of misoprostol for the medical management of first trimester miscarriage is 800 microgram vaginally or 600 microgram sublingually 3 hours apart for 2 doses. Misoprostol is a synthetic analogue of naturally occurring prostaglandin E1 which induces abortion by stimulating the myometrium and cause cervical ripening and dilatation. Misoprostol has also been used in conjunction with other medications such as Mifepristone to boost success rates up to 95%. Mifepristone in low dose, 200 mg single per oral dose, works by antagonizing progesterone hormone which is the main hormone for pregnancy continuation. Letrozole is an oral aromatase inhibitor that can prevent the production of estrogen. It has been found to be effective in the medical termination of pregnancy when coupled with misoprostol. After extensive literature search, very few studies could be found which has compared the efficacy of letrozole v/s mifepristone as pretreatment for medical management of early trimester of pregnancy termination as well no such studies could be found from this part of country. Considering the above fact, the present study has been planned to compare the efficacy between Letrozole pretreatment and Mifepristone pre treatment following Misoprostol in early termination of pregnancy for complete evacuation in medical method.

Till now I have recruited 40 cases.

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 60.00 Year(s)(—)
性别
Female

入选标准

  • Aged ≥18 years and planned for first trimester missed miscarriage with or without vaginal bleeding at 6-9 complete weeks of gestation
  • With a singleton pregnancy.
  • Who agreed to participate in the trial volunterally.
  • Who had no contraindications for medical abortion.

排除标准

  • 1.Incomplete or invitable miscarriage defined by the clinical finding of an open cervix with bleeding 2.suspected ectopic pregnancy 3.history of heart liver or kidney disease or adrenal insufficiency abnormal uterine lessons such as adenomyosis fibroid or congenital malformations or intra uterine adhesion 4.pregnancy with an intra uterine contraceptive device in situ 5.history of coagulataory dysfunction or intake of anticoagulant drugs 6.hemoglobin level of less than 9.5 gram.

结局指标

主要结局

Complete evacuation of conceptus

时间窗: 17 days

次要结局

  • Time interval between consumption of medication and expulsion of product of conception(17 days)

研究者

发起方
Sanchari Debnath
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanchari Debnath

AGARTALA GOVERNMENT MEDICAL COLLEGE AND GBP HOSPITAL.

研究点 (1)

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