This is a double blinded randomized placebo controlled clinical trial to detect the efficacy and safety of vaginal progesterone alone or combined with aspirin in prevention of recurrent PTB.
The included women will be randomly allocated to prophylactically receive either vaginal progesterone at a dose of 200 mg (prontogest 200mg every 12 hr) combined with oral aspirin at a dose of 100mg once daily both at the same time (group1), or vaginal progesterone (prontogest 200mg every 12 hr) and oral placebo (manufactured in a standard way to have the same size and shape of asprin tablet) also at the same time (group 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
256
group1: oral aspirin at a dose of 100mg once daily at the same time with progesterone
group 2: oral placebo once daily at the same time with progesterone
Menoufia University
Shibīn al Kawm, Egypt
Number of participants who will deliver before 34 weeks gestation.
Number of participants who have preterm delivery before 34 weeks gestation
Time frame: 18 month
The number of participants who have prolongation of pregnancy after 34 till 37 weeks gestation
Number of participants who will deliver after 34w gestation and neonatal outcomes
Time frame: 18 months
Neonatal outcomes
Neonatal birth weight Admission to NICU Neonatal complications
Time frame: 18 months
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