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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progesterone group | Active Comparator | Vaginal progesterone suppositories will be given |
|
| Cerclage group | Active Comparator | Cervical cerclage will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm labor before 35 weeks | Up to 35 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery before 37 weeks | Up to 37 weeks gestational age | |
| Low birth weight (LBW) | Birth weight of a living neonate of < 2500 gm regardless of gestational age | At birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed El-refaie, Dr | Contact | wrefaie@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Waleed El-refaie, Dr | Port Said University | Principal Investigator |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Director |
| Ahmed M Badawy, Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Cervical cerclage | Procedure | 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) |
|
|
| Neonatal respiratory distress syndrome (RDS) | At birth |
| Early neonatal death (END) | One month after birth |
| Mansoura University |
| Study Chair |
| Private practice settings | Recruiting | Al Mansurah | Dakahlia Governorate | Egypt |
| Obstetrics and Gynecology Department in Port Said University | Recruiting | Port Said | Egypt |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |