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Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa
The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.
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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 26-28 week and up to 37-weeks' gestation or delivery |
|
| vaginal progesterone | Active Comparator | vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery |
|
| control group | No Intervention | Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-OHPC | Drug | received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery. |
| Measure | Description | Time Frame |
|---|---|---|
| number of patient delivered before 37 weeks | calculation the number of patients delivered before 37 weeks | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| number of episodes of antepartum hemorrhage | calculating the mean number of episodes of antepartum hemorrhage | 2 month |
| Hospital admission for significant antepartum hemorrhage | Number of patients requiring hospital admission for significant antepartum hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
pregnant women with placenta previa
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam, md | 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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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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A randomized controlled study
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An open-label randomized controlled study
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|
| vaginal progesterone | Drug | vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery |
|
|
| 2 month |
| Neonatal Birth weight | measure Neonatal Birth weight in kilograms | one hours post operative |
| D010922 | Placenta Diseases |
| 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 |