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Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa
Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa.
The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth.
Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa.
The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 17-OHPC | Active Comparator | patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
|
| placebo to 17-OHPC | Placebo Comparator | patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-OHPC | Drug | patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
| Measure | Description | Time Frame |
|---|---|---|
| the duration of prolongation of pregnancy from the time of enrollment to the time of delivery | measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| apgar score | measure apgar score from 0 to 10 | 5 minutes postpartum |
| the number of patients with postpartum hemorrhage | calculation the number of patients with postpartum hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women with symptomatic placenta previa
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam | Contact | 01022336052 | 002 | hany.farouk@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D010923 | Placenta Previa |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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A Double-Blind Randomized Clinical Trial
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A Double-Blind Randomized Clinical Trial
|
| placebo to 17-OHPC | Drug | patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
|
|
| 24 hours post operative |
| D010922 | Placenta Diseases |