Complete Miscarriage
Conditions
Keywords
Letrozole, Misoprostol, First-Trimester, Pretreatment
Brief summary
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.
Detailed description
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
Interventions
DRUGLetrozole
DRUGMisoprostol
OTHERPlacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Maternal age more than 18 years old (age of legal consent). * Gestational age less than 13 weeks. * Hemoglobin \>10 g/dL. * BMI between 25 kg/m2 and 35 kg/m2. * Missed abortion. * Living fetus with multiple congenital malformations incompatible with life.
Exclusion criteria
* Maternal age less than 18 years old. * Gestational age more than 12 weeks. * Hemoglobin \<10 g/dL. * Anencephaly. * Fibroid uterus. * BMI less than 25kg/m2 and more than 35kg/m2. * Coagulopathy. * History or evidence of adrenal pathology. * Previous attempts for induction of abortion in the current pregnancy. * Allergy to misoprostol or letrozole. * Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complete abortion | 1 week | complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for surgical evacuation of the products of conception | 1 week | 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 | 1 week | Maternal morbidity * Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion) * Minor side effects (fever, rigors, nausea, vomiting) |
| Hemoglobin and hematocrit deficit | 1 week | — |
Countries
Egypt
Outcome results
None listed