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different protocol started, new registration
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Preterm birth (PTB), defined as birth between 20 and 36 6/7 weeks, is responsible for the majority of the neonatal morbidity and mortality in the United States, and 35% of all U.S. healthcare spending on infants. Globally, about 28% of the 4 million annual neonatal deaths are directly attributable to PTB.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
The aim of this study is to evaluate the efficacy of maintenance tocolysis with Arabin pessary compared to standard care in singleton gestations with arrested PTL and with short transvaginal ultrasound (TVU) cervical length (CL) <25mm
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cervical pessary | Experimental | Arabin cervical pessary |
|
| Standard care | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arabin cervical pessary | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth (SPTB) | Less than 34 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth (SPTB) | Less than 37,35,32,28 and 24 weeks gestation | |
| Gestational age at delivery | mean gestational age at delivery | Delivery (at birth) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | 80100 | Italy |
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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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| Latency | mean latency in days (from randomization to delivery) | Delivery (at birth) |
| Birth weight | mean birth weight in grams | Delivery (at birth) |
| Admission to neonatal intensive care unit | Delivery (at birth) |
| respiratory distress syndrome | Delivery (at birth) |
| low birth weight | birth weight <2500 grams | Delivery (at birth) |
| intraventricular hemorrhage | grade 3 or 4 | Between birth and 28 days of age |
| neonatal mortality | death of a live-born baby within the first 28 days of life | Between birth and 28 days of age |
| D000091642 | Urogenital Diseases |