Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 5:26 AM
Study NCT ID:
NCT02405156
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.
Detailed Description:
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Data recording:
1. Duration of complete abortion.
2. Post abortion bleeding.
3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.
4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
5. Recording maternal morbidities.
6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Data recording:
1. Duration of complete abortion.
2. Post abortion bleeding.
3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.
4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
5. Recording maternal morbidities.
6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: