Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally).
The main questions this study aims to answer are:
ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included.
What Will Happen in the Study A total of 92 women will take part.
Participants will be randomly assigned to one of two groups:
Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol.
Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol.
Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed.
Products of conception will be examined to confirm abortion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol with placebo | Active Comparator | Vaginal Misoprostol will be instituted after oral placebo |
|
| Misoprostol with Letrozole | Experimental | After oral letrozole, vaginal Misoprostol will be instituted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol (given vaginally) | Drug | 800 micrograms of a single dose of vaginal misoprostol will be given |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortion | The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound. | From start of study medication after randomization to within 24-hours |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Induction-abortion interval | The time interval (in hours) from the administration of first dose of Misoprostol up to the time when the fetus aborted. | From start of study medication to abortion, within 24-hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Afrayshum T Principal Investigator, MBBS | Contact | +92 3336239197 | afrayshumtariq@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rabia R Assistant Professor, FCPS | Nishtar Medical University and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishtar Medical University and Hospital | Recruiting | Multan | Punjab Province | 60000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30647756 | Background | Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000027 | Abortion, Incomplete |
| D000030 | Abortion, Missed |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016595 | Misoprostol |
| C078133 | Arthrotec |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Letrozole 5 mg | Drug | 10 mg oral letrozole for 3 days will be given |
|
|
| Placebo | Drug | oral placebo for three days will be given |
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |