The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
Aswan University
Aswān, Egypt
RECRUITINGPreterm labor before 34 weeks gestations
Number of patients delivered before 34 weeks gestations
Time frame: Up to 34 weeks gestational age
Neonatal respiratory distress syndrome
Number of neonates develop respiratory distress syndrome
Time frame: At birth
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Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age