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Идёт набор NCT07109947

Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage

Без фазы С лечением Miscarriage

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Letrozole 2.5mg.
Кому может быть актуально
Состояния в реестре: Miscarriage. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage

Обзор

Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.

Подробное описание

Various medical and surgical methods have been used to manage missed abortions. Surgical methods include dilatation and curettage, and vacuum aspiration. Because these methods are expensive and involve anesthesia, however, medical methods are generally preferred over surgical methods for abortion.

Medical approaches include misoprostol which is a prostaglandin that causes myometrial contractions, cervical softening and dilatation. It is used to induce abortion and labor and to treat atonic postpartum hemorrhage and peptic ulcers.

It has the advantage of being cost-effective and stable with a low rate of side effects which has led to it being included in the World Health Organization list of essential medications (2014). Misoprostol is licensed for use to induce miscarriage in Egypt. It has not been licensed to induce labor or miscarriage in certain countries such as Germany, but it is used off-label to induce labor in the UK.

Usage of Misoprostol alone has a success rate of between 65 and 93% especially in the early stages of pregnancy. It can also use in combination with other medications such as mifepristone and methotrexate to increase the success rate.

Most studies have examined the effect of letrozole plus misoprostol on the abortion of live embryos .Given the significance of specifying an effective and safe method for termination of abortion and the specific features of letrozole, such as its safety, cost-effectiveness, and availability.

Вмешательства

  • Препарат Letrozole 2.5mg
    to determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage.

Первичные конечные точки

  • Miscarriage Achievement [Срок оценки: 10 days]

Критерии участия

Критерии включения

  • Missed or anembryonic pregnancy.
  • Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
  • Hemoglobin level more than 9g/l.
  • Closed cervix.
  • No product of conception in the cervical canal.

Критерии исключения

  • Previous attempt to terminate the pregnancy.
  • Molar pregnancy
  • Abnormal uterine lesions such as fibroids or congenital mal formations.
  • Pregnancy despite of intrauterine contraceptive device.
  • Medical disorders as cardiac, renal or hemorrhagic diseases.
  • BMI more than 35 kg/m2.
  • Known hypersensitivity to any of the medication used.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Aswan University Hospital — Aswān

Идентификаторы

NCT: NCT07109947 · Arwa Ashraf

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗