Premature Labour
Conditions
Keywords
Preterm labor, Short cervix, Progesterone, Cervical cerclage
Brief summary
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.
Detailed description
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.
Interventions
DRUGProgesterone
Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
PROCEDURECervical cerclage
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)
Sponsors
Mohamed Sayed Abdelhafez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women with singleton pregnancy. * History of preterm labor and/or midtrimester miscarriage in a previous pregnancy. * Cervical length of 15-25 mm by transvaginal sonography (TVS) at 16-24 weeks of gestation.
Exclusion criteria
* Age \< 20 or \> 35 years. * Congenital uterine malformation. * Multifetal pregnancy. * Known major fetal structural or chromosomal abnormality. * Known allergy or contraindication (relative or absolute) to progesterone therapy. * Presence of contraindication to cervical cerclage. * Medical conditions complicating pregnancy. * Vaginal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preterm labor before 35 weeks | Up to 35 weeks gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery before 37 weeks | Up to 37 weeks gestational age | — |
| Low birth weight (LBW) | At birth | Birth weight of a living neonate of \< 2500 gm regardless of gestational age |
| Neonatal respiratory distress syndrome (RDS) | At birth | — |
| Early neonatal death (END) | One month after birth | — |
Countries
Egypt
Contacts
Primary ContactWaleed El-refaie, Dr
Outcome results
None listed