Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy

Обзор

Incomplete abortion has an eminent clinical diagnosis and is characterized by transvaginal bleeding associated with an open uterine cervix upon physical examination when the products of conception have not been wholly discharged. This is the most frequent clinical presentation of this condition. Currently, misoprostol (prostaglandin E2 analog), along with mifepristone, is the reference drug for medicated uterine emptying in cases of spontaneous or induced abortion, both in the first gestational trimester and at more advanced gestational ages.Misoprostol-only is a safe and effective option for females with missed abortion in the first trimester, although less effective than standard regimens that also contain mifepristone.Once the efficacy, safety, and acceptability of misoprostol in incomplete abortion are well established, future studies must be done in finding the ideal route of administration (oral, sublingual, or vaginal), perfect dosage, and intervals of administration when necessary. The purpose of this study is to evaluate the safety and effectiveness of oral versus vaginal misoprostol in cases of missed abortions during the first trimester of pregnancy. Misoprostol is widely used for medical management of early pregnancy loss; however, the optimal route of administration remains uncertain. Comparing these two routes may help identify the most effective and safest method, thereby improving patient outcomes and guiding clinical practice. According to literature, misoprostol administered vaginally has better effectiveness and fewer side effects. However, conflicting evidence has been found in literature that indicates there is no difference between both route for misoprostol administration. In order to determine the best course of action with the fewest adverse effects for women who have missed an abortion, we wish to carry out this experiment. In order to apply the more appropriate route to the local community, adopt a more effective approach, and revise the criteria for doing so. This will enhance our expertise and methods as well as will improve patients' satisfaction will treatment.

Вмешательства

• Препарат Oral misoprostol
  In group A, females will be given 400 µg orally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.
• Препарат Misoprostol (given vaginally)
  In group B, females will be given 400 µg vaginally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.

Первичные конечные точки

• Induction to Expulsion Interval [Срок оценки: 48 hours]
• Efficacy of Oral Versus Vaginal route [Срок оценки: 24 hours]

Вторичные конечные точки (1)

• Safety of Oral Misoprostol versus Vaginally administered Misoprostol [Срок оценки: 48hours]

Критерии участия

Критерии включения

• Parity <5
• Presenting with missed abortion (defined as spontaneous loss of pregnancy, presence of lower abdomen cramps, ultrasound scan shows no fetal cardiac activity during 8-16 weeks of pregnancy)

Критерии исключения

• Pregnancy with any degree of cervical dilatation
• Signs or symptoms of infection,
• Twin gestation sac, molar pregnancy (on ultrasound),
• Excessive uterine bleeding,
• Blood pressure ≥160/90 mmHg,
• Maternal history of asthma or cardiac or cerebral disease

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

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• PNS Hafeez — Islamabad

Идентификаторы

NCT: NCT07526064 · 27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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