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Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone | Active Comparator | Participants with 1st trimester miscarriage will receive oral 200mg mifepristone . After 48 hours of mifepristone, 800 micro gm misoprostol will be given vaginally for expulsion of product of conception (standard care). |
|
| Letrozole | Experimental | Participants with 1st trimester miscarriage will receive 10mg letrozole orally for three consecutive days. This is to be followed by tablet misoprostol 800 micro gm vaginally for expulsion of product of conception (standard care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Participants with 1st trimester miscarriage will receive for medical termination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Expulsion of product of conception | Mean duration of expulsion since administration of vaginal misoprostol | 24 hours since administration of misoprostol |
| Requirement of surgical evacuation | Surgical evacuation where complete abortion does not occur | beyond 24 hours since misoprostol administration |
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INCLUSION CRITERIA :
EXCLUSION CRITERIA :
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calcutta National Medical College and Hospital | Kolkata | West Bengal | 700014 | India |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Letrozole | Drug | Participants with 1st trimester miscarriage will receive for medical termination |
|
|
| D011083 |
| Polycyclic Compounds |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |