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In women with unexplained recurrent miscarriages, progesterone (400 mg pessaries, twice daily), started soon as possible at luteal phase and after a positive pregnancy test and continued to 28 weeks of gestation, compared to placebo, ).
Progesterone improves secondary outcomes such as gestation at delivery, on-going pregnancy at 12 weeks, survival at 28 days of neonatal life.
. Progesterone, compared to placebo, does not incur substantial adverse effects to the mother or the neonate.
Explore differential or subgroup effects of progesterone in prognostic subgroups.
. Perform an economic evaluation for cost-effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone group | Active Comparator | progesterone (400 mg pessary, once daily) |
|
| Placebo group | Placebo Comparator | Placebo (pessary, once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients continued the pregnancy beyond 20 weeks gestation. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of miscarriages | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Live Birth | 2 years | |
| Number of preterm delivery | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaa M Ismail, M D | Faculity of medicine,Assiut university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Hospital | Asyut | Egypt |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |