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The primary objective of this study, is to determine the effect of a Cup pessary, a device that is currently readily available in the USA and similar in design to the Arabin pessary, on the incidence of delivery prior to 37 weeks in women with a history of prior spontaneous birth (before 37 weeks) and incidentally found to have a cervix less than 25 mm in length prior to 23 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pessary use during pregnancy | Experimental | Device: Cup pessary |
|
| Expectant management | No Intervention | Expectant Management + weekly intramuscular progesterone injections |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cup pessary (Bioteque America, Inc) | Device | Placement of cup pessary in the vagina after randomization |
|
| Measure | Description | Time Frame |
|---|---|---|
| delivery prior to 37 weeks of gestation | Gestational age at birth will be recorded | within the first 30 days after delivery of the neonate |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of birth less than seven days from randomization | Gestational age at birth will be recorded | within the first 30 days after delivery of the neonate |
| Previable birth (<24 weeks) | Gestational age at birth will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita W Driggers, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
| Washington Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8569824 | Background | Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904. | |
| 19788970 |
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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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| within the first 30 days after delivery of the neonate |
| Perinatal death | defined as either a stillbirth or postnatal death prior to hospital discharge | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Low birth weight | Birthweight at delivery will be recorded | within the first 30 days after delivery of the neonate |
| Major adverse neonatal outcomes | intraventricular hemorrhage, respiratory distress syndrome of the newborn, retinopathy of prematurity, or necrotizing enterocolitis | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Need for neonatal special care | ventilation, phototherapy, treatment for sepsis, blood transfusion | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Incidence of complications due to pessary | Incidence of bacterial vaginosis, urinary tract infections, vaginal erosions will be recorded at monthly visits. | Every 4 weeks while pregnant with pessary in situ |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Franklin Square Hospital | Baltimore | Maryland | 21237 | United States |
| Owen J, Hankins G, Iams JD, Berghella V, Sheffield JS, Perez-Delboy A, Egerman RS, Wing DA, Tomlinson M, Silver R, Ramin SM, Guzman ER, Gordon M, How HY, Knudtson EJ, Szychowski JM, Cliver S, Hauth JC. Multicenter randomized trial of cerclage for preterm birth prevention in high-risk women with shortened midtrimester cervical length. Am J Obstet Gynecol. 2009 Oct;201(4):375.e1-8. doi: 10.1016/j.ajog.2009.08.015. |
| 12802023 | Background | Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140. |
| 5646408 | Background | Vitsky M. Pessary treatment of the incompetent cervical os. Obstet Gynecol. 1968 May;31(5):732-3. doi: 10.1097/00006250-196805000-00024. No abstract available. |
| 5944837 | Background | Oster S, Javert CT. Treatment of the incompetent cervix with the Hodge pessary. Obstet Gynecol. 1966 Aug;28(2):206-8. doi: 10.1097/00003081-196608000-00011. No abstract available. |
| 12747228 | Background | Arabin B, Halbesma JR, Vork F, Hubener M, van Eyck J. Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? J Perinat Med. 2003;31(2):122-33. doi: 10.1515/JPM.2003.017. |
| 14669390 | Background | Antczak-Judycka A, Sawicki W, Spiewankiewicz B, Cendrowski K, Stelmachow J. [Comparison of cerclage and cerclage pessary in the treatment of pregnant women with incompetent cervix and threatened preterm delivery]. Ginekol Pol. 2003 Oct;74(10):1029-36. Polish. |
| 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 |