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This study evaluates the efficacy of prophylactic vaginal progesterone administration in reducing of the episodes of antepartum hemorrhage and subsequent prevention of preterm delivery in women with placenta previa.
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal progesterone group | Active Comparator | Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer). |
|
| 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 |
|---|---|---|---|---|
| Vaginal progesterone | Drug | 400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of preterm delivery due to severe antepartum hemorrhage. | Number of patients who delivered before 37 weeks gestational age | from 26 weeks till 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| No. of episodes of antepartum hemorrhage. | Mean number of episodes of antepartum hemorrhage | from 26 weeks till 37 weeks |
| Hospital admission for significant antepartum hemorrhage. | Number of patients requiring hospital admission for significant antepartum hemorrhage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Samy, MD | Contact | 01001947488 | mohammedsamy8132@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Samy, MD | M Samy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain SHams Maternity Hospital | Recruiting | Cairo | Abbaseya | 002 | 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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|
| from 26 weeks till 37 weeks |
| Hospital admission for threatened preterm labor. | Number of patients requiring hospital admission for threatened preterm labor | from 26 weeks till 37 weeks |
| Need for blood transfusion. | Number of patients requiring blood transfusion | from 26 weeks till 37 weeks |
| Incidence of severe postpartum hemorrhage. | Number of patients who had severe postpartum hemorrhage | from 26 weeks till 37 weeks |
| Incidence of Cesarean hysterectomy. | Number of patients who underwent cesarean hysterectomy | from 26 weeks till 37 weeks |
| Patient compliance | measured as mean number of doses of vaginal progesterone missed per week | from 26 weeks till 37 weeks |
| Patient satisfaction: Likert Scale | measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied. | from 26 weeks till 37 weeks |
| Neonatal Birth weight. | measured in Kg | At birth |
| Need for NICU admission and its duration. | Number of neonates needing NICU admission | At birth |
| Respiratory morbidity (transient tachypnea or respiratory distress syndrome). | number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome). | At birth |
| Prematurity-related mortality. | Number of neonates dying due to prematurity-related cause | 28 days postpartum |
| D010922 | Placenta Diseases |