Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
الكلمات الدالة
نبذة مختصرة
وصف
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
تواريخ
| آخر التحقق: | 08/31/2015 |
| تم الإرسال لأول مرة: | 02/24/2015 |
| تم إرسال التسجيل المقدر: | 03/23/2015 |
| أول نشر: | 03/26/2015 |
| تم إرسال آخر تحديث: | 09/26/2015 |
| آخر تحديث تم نشره: | 09/28/2015 |
| تاريخ بدء الدراسة الفعلي: | 02/28/2015 |
| تاريخ الإنجاز الأساسي المقدر: | 08/31/2015 |
| التاريخ المتوقع لانتهاء الدراسة: | 08/31/2015 |
حالة أو مرض
التدخل / العلاج
Drug: letrozole
Drug: Misoprostol
Other: placebo
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Active Comparator: letrozole Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. | Drug: letrozole |
| Placebo Comparator: placebo Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. | Other: placebo |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | Female |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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). |
النتيجة
مقاييس النتائج الأولية
1. Incidence of complete abortion [1 week]
مقاييس النتائج الثانوية
1. Need for surgical evacuation of the products of conception [1 week]
2. Maternal morbidity [1 week]
3. Hemoglobin and hematocrit deficit [1 week]
