The aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.
Women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (TVS) starting from 16 weeks till 24 weeks of gestation. Eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. At 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. For women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. For women in the cerclage group, McDonald cervical cerclage will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
220
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGPrivate practice settings
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGObstetrics and Gynecology Department in Port Said University
Port Said, Egypt
RECRUITINGPreterm labor before 35 weeks
Time frame: Up to 35 weeks gestational age
Delivery before 37 weeks
Time frame: Up to 37 weeks gestational age
Low birth weight (LBW)
Birth weight of a living neonate of \< 2500 gm regardless of gestational age
Time frame: At birth
Neonatal respiratory distress syndrome (RDS)
Time frame: At birth
Early neonatal death (END)
Time frame: One month after birth
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