Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

Study Overview
=================
Brief Summary
-----------------
Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. Hypothesis: Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. Research question: Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Detailed Description
-----------------
Aim of the Work Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester. Hypothesis: Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester. Research question: Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester? Primary outcome: Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol. Secondary outcome: • Curettage (surgical evacuation of the products of conception) Incomplete abortion (retained products of conception). Considerable bleeding that necessitates immediate evacuation.

Official Title
-----------------
Study at Zagazig General Hospital

Conditions
-----------------
Missed Abortion

Intervention / Treatment
-----------------
* Device: Letrozole misoprostol
* Drug: Misoprostol, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Woman age more than 18 years old (age of legal consent). BMI ranges between 25 kg/m2 and 35 kg/m2. Gestational age of 63 days' gestation (or less). Missed abortion. Hemoglobin leve Exclusion criteria: Woman age less than 18 years old. BMI less than 25 kg/m2 or more than 35 kg/m2. Gestational age more than 63 days' gestation. Molar pregnancy. Hemoglobin level less than 10 gm/dL. Fibroid uterus. Uterus with congenital anomalies. Previous attempts for induction of abortion in the current pregnancy. Coagulation defect i.e. coagulopathy. Contraindication for induction of abortion e.g. heart failure. Allergy to misoprostol or letrozole.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Letrozole misoprostol<br>Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start | Device: Letrozole misoprostol<br>* Letrozole give pretreatment of abortion by misoprostol<br>|
| Misoprostol,placebo<br>Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start | Drug: Misoprostol, placebo<br>* Give placebo pretreatment of abortion by misoprostol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion | Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol. | 1week |