Abortion, Abortion Induced Complicated
Conditions
Keywords
medical abortion, induced abortion
Brief summary
Termination of Second trimester Abortion with Letrozole and Misoprostol Compared to Misoprostol Alone
Detailed description
An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: * Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol. * Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. This study will be open-label due to different drugs and route of administrations used.
Interventions
DRUG· Misoprostol + letrozole
1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion.
1. to compare the effect of letrozole plus misoprostol versus misoprostol alone for termination of second-trimester pregnancy. 2. to compare efficacy of letrozole and misoprostol versus misoprostol alone in theraputic abortion (living fetus) versus missed abortion
Sponsors
Sohag University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An online randomization program will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two equal groups in a parallel manner: * Group I (Letrozole + Misoprostol): Patients will receive letrozole 2.5 mg orally the dose of letrozole is 4 tab once/day for 3 consecutive days, followed by vaginal misoprostol. * Group II (Misoprostol alone (: Patients will receive vaginal misoprostol alone using the same dosage schedule without letrozole pretreatment. This study will be open-label due to different drugs and route of administrations used.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women aged 18-45 years. * Failed pregnancy. * Gestational age between 14 and 20weeks, confirmed by ultrasonography on the day of admission. * Hemoglobin concentration \>9 g/dL. * Closed cervix. * Absence of products of conception in the cervical canal. \-
Exclusion criteria
* Previous attempt to terminate the current pregnancy. * Molar pregnancy (hydatidiform mole). * Pathological uterine lesions including uterine fibroids and congenital uterine malformations. * Cardiac disease. * Renal disease. * Hemorrhagic disorders. * Body mass index (BMI) \>35 kg/m². * Documented hypersensitivity or allergy to letrozole, misoprostol, or any of the study medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| · Complete abortion rate. | 1 weak |
Contacts
CONTACTahmed khalifa elsayed, resident
Outcome results
None listed