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Financial/business decision by Sponsor to not proceed with this study
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A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\
A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical Cerclage + Progesterone | Active Comparator | Placement of a Cervical Cerclage plus the daily administration of vaginal progesterone (200mg tab) |
|
| Progesterone | Placebo Comparator | Daily administration of vaginal progesterone (200mg tab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Cerclage placement | Procedure | Cervical Cerclage placement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of very preterm birth (PTB) | Rate of very PTB (PTB less than 32 weeks) | Time frame measured on the date the infant is born. We anticipate this time frame to be approximately 16 weeks. |
| Rate of adverse perinatal outcome | The rate of adverse perinatal outcome defined as any one or more of the following: Miscarriage, stillbirth, neonatal death, respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage (grade III or IV), necrotizing enterocolitis, culture proven sepsis. | Time frame measured 28 days after the infant is born. We anticipate this time frame to be approximately 28 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Combs, MD | Pediatrix | Principal Investigator |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D002581 | Uterine Cervical Incompetence |
| 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 |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Two groups: Cerclage + Progesterone vs. Progesterone alone
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| Vaginal Progesterone |
| Drug |
200mg tab of vaginal progesterone administered daily from time of randomization until delivery. |
|
|
| D000091642 | Urogenital Diseases |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D000091662 | Genital Diseases |
| 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 |