Placenta Previa
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVaginal progesterone
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).
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Gestational age 26-28 weeks of gestation. 2. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan.
Exclusion criteria
1. Multiple pregnancy. 2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM). 3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. 4. Women who have been maintained on progestin therapy since early pregnancy for whatever reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of preterm delivery due to severe antepartum hemorrhage. | from 26 weeks till 37 weeks | Number of patients who delivered before 37 weeks gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital admission for significant antepartum hemorrhage. | from 26 weeks till 37 weeks | Number of patients requiring hospital admission for significant antepartum hemorrhage |
| Hospital admission for threatened preterm labor. | from 26 weeks till 37 weeks | Number of patients requiring hospital admission for threatened preterm labor |
| Need for blood transfusion. | from 26 weeks till 37 weeks | Number of patients requiring blood transfusion |
| Incidence of severe postpartum hemorrhage. | from 26 weeks till 37 weeks | Number of patients who had severe postpartum hemorrhage |
| Incidence of Cesarean hysterectomy. | from 26 weeks till 37 weeks | Number of patients who underwent cesarean hysterectomy |
| No. of episodes of antepartum hemorrhage. | from 26 weeks till 37 weeks | Mean number of episodes of antepartum hemorrhage |
| Patient satisfaction: Likert Scale | from 26 weeks till 37 weeks | measured according to the 5-grade Likert scale: very unsatisfied, unsatisfied, indifferent, satisfied and very satisfied. |
| Neonatal Birth weight. | At birth | measured in Kg |
| Need for NICU admission and its duration. | At birth | Number of neonates needing NICU admission |
| Respiratory morbidity (transient tachypnea or respiratory distress syndrome). | At birth | number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome). |
| Prematurity-related mortality. | 28 days postpartum | Number of neonates dying due to prematurity-related cause |
| Patient compliance | from 26 weeks till 37 weeks | measured as mean number of doses of vaginal progesterone missed per week |
Countries
Egypt
Contacts
Primary ContactMohamed Samy, MD
Outcome results
None listed