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| Name | Class |
|---|---|
| Hospital Universitario de Canarias | OTHER |
| Hospital Son Llatzer | OTHER |
| Fundacion Dexeus | OTHER |
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Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | Expectant management | |
| 2 | Experimental | Placement of arabin pessary since 23 weeks until 37 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicon ring (Arabin Pessary) | Device | Placement of a silicon pessary in the vagina, around the cervix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Delivery Before 34 Completed Weeks | Number of spontaneous preterm births before 34 weeks occurred in each group. | Between 24 and 34 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Birthweight Less Than 1500 g | Number of newborns whose birthweight is less than 1500 grams | Time of delivery |
| Birthweight Less Than 2500 g | Number of newborns whose birthweight is less than 2500 grams |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ELENA CARRERAS, PhD | Maternal-Infantil Vall d´Hebron Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Materno-Infantil de Canarias | Las Palmas de Gran Canaria | Gran Canaria | 35016 | Spain | ||
| Hospital Son Llà tzer |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22475493 | Derived | Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. |
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You are right that our fi rst planned sample size was 2780 patients. However, after the first interim analysis, and in accordance with the advice of our Data Monitoring Committee, the protocol was amended to reach the new and fi nal sample size.
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| ID | Title | Description |
|---|---|---|
| FG000 | Expectant Management | Expectant management: Current conventional management. |
| FG001 | Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks | Placement of arabin pessary since 23 weeks until 37 weeks Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Expectant Management | Both groups were seen by the clinical team of the trial at each centre every month until delivery. Transabdominal ultrasonography was done for fetal biometries and wellbeing, clinical questionnaire was administered for confi rmation of correct device placement in the pessary group (fi gure 2), vaginal swab was taken for study of bacteriological infection, and transvaginal ultra sonography was done to measure cervical length (fi gure 3) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spontaneous Delivery Before 34 Completed Weeks | Number of spontaneous preterm births before 34 weeks occurred in each group. | Posted | Count of Participants | Participants | Between 24 and 34 weeks |
|
Starting at 24 weeks until 28 days after birth
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Expectant Management | Expectant management: usual management | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria M Goya | Hospital Vall d'Hebron | 934893085 | 4652 | maria.goya@vhir.org |
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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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| Time of delivery |
| Intrauterine Fetal Demise | The number of fetal deaths in the pessary group was compared to those in the no pessary group | Pregnancy |
| Neonatal Death | The number of neonatal deaths in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Intraventricular Haemorrhage | The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Respiratory Distress Syndrome | The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Retinopathy of Prematurity | The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Necrotising Enterocolitis | The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Treatment for Sepsis | The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Composite Adverse Outcomes | The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group | Between birth and 28 days of age |
| Spontaneous Delivery Before 28 Completed Weeks | Number of preterm births before 28 weeks occurred in each group. | Between 24 and 28 weeks |
| Any Delivery Before 34 Completed Weeks | Number of all preterm births before 34 weeks occurred in each group. | Between 24 and 34 weeks |
| Spontaneous Delivery Before 37 Completed Weeks | Number of preterm births before 37 weeks occurred in each group. | Between 24 and 37 weeks |
| Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | At time of birth |
| Use of Tocolysis | Number of participants required use of tocolytic medication | participants will be followed for the duration of pregnancy, up to nine months |
| Use of Antenatal Steroids | Number of participants that received betamethasone to reduce morbidity of expected preterm delivery | participants will be followed for the duration of pregnancy, up to nine months |
| Chorioamnionitis | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. | participants will be followed for the duration of pregnancy, up to nine months |
| Vaginal Bleeding | Number of participants who experienced bleeding from lower genital tract during antepartum period | participants will be followed for the duration of pregnancy, up to nine months |
| Preterm Premature Rupture of Membranes | Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test. | participants will be followed for the duration of pregnancy, up to nine months |
| Cesarean Delivery | Number of participants that underwent cesarean delivery | At time of delivery |
| Vaginal Discharge | Number of participants who experienced an increased vaginal discharge. | participants will be followed for the duration of pregnancy, up to nine months |
| Pessary Repositioning Without Removal | Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | participants will be followed for the duration of pregnancy, up to nine months |
| Pessary Withdrawal | Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | participants will be followed for the duration of pregnancy, up to nine months |
| Palma de Mallorca |
| Mallorca |
| 07198 |
| Spain |
| Hospital de Reus | Reus | Tarragona | Spain |
| Hospital Vall d´Hebron | Barcelona | 08035 | Spain |
| Institut Universitary Dexeus | Barcelona | Spain |
| Hospital de Fuenlabrada | Madrid | Spain |
| BG001 | Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks | The pessary was removed during the 37th week of gestation. Indications for pessary removal before this time were active vaginal bleeding, risk of preterm labour with persistent contractions despite tocolysis, or severe patient discomfort. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Birthweight Less Than 1500 g | Number of newborns whose birthweight is less than 1500 grams | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Birthweight Less Than 2500 g | Number of newborns whose birthweight is less than 2500 grams | Posted | Count of Participants | Participants | Time of delivery |
|
|
|
| Secondary | Intrauterine Fetal Demise | The number of fetal deaths in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Pregnancy |
|
|
|
| Secondary | Neonatal Death | The number of neonatal deaths in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Intraventricular Haemorrhage | The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Respiratory Distress Syndrome | The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Retinopathy of Prematurity | The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Necrotising Enterocolitis | The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Treatment for Sepsis | The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Composite Adverse Outcomes | The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group | Posted | Count of Participants | Participants | Between birth and 28 days of age |
|
|
|
| Secondary | Spontaneous Delivery Before 28 Completed Weeks | Number of preterm births before 28 weeks occurred in each group. | Posted | Count of Participants | Participants | Between 24 and 28 weeks |
|
|
|
| Secondary | Any Delivery Before 34 Completed Weeks | Number of all preterm births before 34 weeks occurred in each group. | Posted | Count of Participants | Participants | Between 24 and 34 weeks |
|
|
|
| Secondary | Spontaneous Delivery Before 37 Completed Weeks | Number of preterm births before 37 weeks occurred in each group. | Posted | Count of Participants | Participants | Between 24 and 37 weeks |
|
|
|
| Secondary | Gestational Age at Delivery | Number of weeks of gestation completed by time of delivery | Posted | Mean | Standard Deviation | weeks | At time of birth |
|
|
|
| Secondary | Use of Tocolysis | Number of participants required use of tocolytic medication | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Use of Antenatal Steroids | Number of participants that received betamethasone to reduce morbidity of expected preterm delivery | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Chorioamnionitis | Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia. | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Vaginal Bleeding | Number of participants who experienced bleeding from lower genital tract during antepartum period | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Preterm Premature Rupture of Membranes | Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test. | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Cesarean Delivery | Number of participants that underwent cesarean delivery | Posted | Count of Participants | Participants | At time of delivery |
|
|
|
| Secondary | Vaginal Discharge | Number of participants who experienced an increased vaginal discharge. | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Pessary Repositioning Without Removal | Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| Secondary | Pessary Withdrawal | Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm). | Posted | Count of Participants | Participants | participants will be followed for the duration of pregnancy, up to nine months |
|
|
|
| 190 |
| 0 |
| 190 |
| 0 |
| 190 |
| EG001 | Placement of Arabin Pessary Since 23 Weeks Until 37 Weeks | Silicon ring (Arabin Pessary): Placement of a silicon pessary in the vagina, around the cervix. | 0 | 190 | 0 | 190 | 0 | 190 |
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| D000091642 | Urogenital Diseases |