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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
74
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).
Ain SHams Maternity Hospital
Cairo, Abbaseya, Egypt
RECRUITINGIncidence of preterm delivery due to severe antepartum hemorrhage.
Number of patients who delivered before 37 weeks gestational age
Time frame: from 26 weeks till 37 weeks
No. of episodes of antepartum hemorrhage.
Mean number of episodes of antepartum hemorrhage
Time frame: from 26 weeks till 37 weeks
Hospital admission for significant antepartum hemorrhage.
Number of patients requiring hospital admission for significant antepartum hemorrhage
Time frame: from 26 weeks till 37 weeks
Hospital admission for threatened preterm labor.
Number of patients requiring hospital admission for threatened preterm labor
Time frame: from 26 weeks till 37 weeks
Need for blood transfusion.
Number of patients requiring blood transfusion
Time frame: from 26 weeks till 37 weeks
Incidence of severe postpartum hemorrhage.
Number of patients who had severe postpartum hemorrhage
Time frame: from 26 weeks till 37 weeks
Incidence of Cesarean hysterectomy.
Number of patients who underwent cesarean hysterectomy
Time frame: from 26 weeks till 37 weeks
Patient compliance
measured as mean number of doses of vaginal progesterone missed per week
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Time frame: 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.
Time frame: from 26 weeks till 37 weeks
Neonatal Birth weight.
measured in Kg
Time frame: At birth
Need for NICU admission and its duration.
Number of neonates needing NICU admission
Time frame: At birth
Respiratory morbidity (transient tachypnea or respiratory distress syndrome).
number of neonates with respiratory morbidities (transient tachypnea or respiratory distress syndrome).
Time frame: At birth
Prematurity-related mortality.
Number of neonates dying due to prematurity-related cause
Time frame: 28 days postpartum