The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Cervical cerclage indicated by short cervix ≤25mm
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
Aswan University
Aswān, Egypt
RECRUITINGPreterm labor before 34 weeks
Number of patients with preterm birth before 34 weeks gestations
Time frame: Up to 34 weeks gestational age
Neonatal respiratory distress syndrome
number of neonatal respiratory distress syndrome
Time frame: At birth
Early neonatal death
number babies died in the neonatal period
Time frame: within one month postpartum
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