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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical cerclage | Active Comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm |
|
| vaginal progesterone | Active Comparator | Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks |
|
| Cervical cerclage plus vaginal progesterone | Active Comparator | Cervical cerclage in twin pregnancy with transvaginal cervical length ≤25mm plus Daily vaginal progesterone 400mg from diagnosis of the short cervix to 36 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Cervical cerclage indicated by short cervix ≤25mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm labor before 34 weeks | Number of patients with preterm birth before 34 weeks gestations | Up to 34 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal respiratory distress syndrome | number of neonatal respiratory distress syndrome | At birth |
| Early neonatal death | number babies died in the neonatal period |
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Inclusion Criteria:
Exclusion Criteria:
Women pregnant in dichorionic twins
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam, md | Contact | 01022336052 | 002 | hany.farouk@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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A randomized clinical trial
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A randomized clinical trial open label
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| vaginal progesterone | Drug | Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks |
|
|
| within one month postpartum |
| D000091642 | Urogenital Diseases |