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Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries.
The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. |
|
| 2 | Active Comparator | previous preterm delivery, treatment with daily vaginal natural progesterone |
|
| 3 | Active Comparator | short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate. |
|
| 4 | Active Comparator | short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17 alfa hydroxyprogesterone caproate | Drug | weekly injection of 250 mg until 34 weeks gestation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| comfort of use and consequently of that compliance | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tal Biron-Shental, MD | Meir Medical Center, Israel, Affiliated to Tel Aviv University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | Israel |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| natural progesterone |
| Drug |
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation. |
|
| 17 alfa hydroxyprogesterone caproate | Drug | weekly injection, 250 mg until 34 weeks gestation |
|
| vaginal progesterone | Drug | daily vaginal progesterone 200 mg until 34 weeks gestation. |
|
| D000091642 | Urogenital Diseases |