The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
Primary outcome: Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol) Secondary outcome: Need for surgical evacuation of the products of conception * Incomplete expulsion of the products of conception (incomplete miscarriage). * Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity * Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion) * Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
423
Ain Shams University Maternity Hospital
Cairo, Egypt
Incidence of complete abortion
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
Time frame: 1 week
Need for surgical evacuation of the products of conception
Need for surgical evacuation of the products of conception * Incomplete expulsion of the products of conception (incomplete miscarriage). * Considerable bleeding necessitating immediate surgical evacuation.
Time frame: 1 week
Maternal morbidity
Maternal morbidity * Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion) * Minor side effects (fever, rigors, nausea, vomiting)
Time frame: 1 week
Hemoglobin and hematocrit deficit
Time frame: 1 week
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