Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women (GWGCPW)
11 de mayo de 2017 actualizado por: Jing Tan, West China Hospital
The purpose of this study is to investigate the reference ranges and rates of gestational weight gain among Chinese pregnant women, and to analyze the correlation between gestational weight gain and adverse outcomes.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
10422
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
Descripción
Inclusion Criteria:
- Deliveries between January 2013 and December 2014;
- Gestational age between 37 weeks or older and less than 42 weeks;
- Registration with care documents at the first prenatal visit prior to the 15th gestational week;
- Had at least five follow-up visits until delivery.
Exclusion Criteria: None
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preeclampsia
Periodo de tiempo: After 20th gestational weeks till delivery, about 5 months
|
Maternal systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg during gestation.
Urine protein ≥5.0 g within 24h, urine volume <400 mL.
HELLP syndrome or pulmonary edema present.
|
After 20th gestational weeks till delivery, about 5 months
|
|
Eclampsia
Periodo de tiempo: After 20th gestational weeks till delivery, about 5 months
|
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
|
After 20th gestational weeks till delivery, about 5 months
|
|
ICP
Periodo de tiempo: After 14th gestational weeks till delivery, about 6 months
|
Intrahepatic cholestasis of pregnancy.
|
After 14th gestational weeks till delivery, about 6 months
|
|
Placenta previa
Periodo de tiempo: During pregnancy till delivery
|
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
|
During pregnancy till delivery
|
|
Gestational diabetes
Periodo de tiempo: After 24th gestational weeks, about 4 months
|
By oral glucose tolerance test between 24th and 28th gestational weeks (fasting glucose ≥5.1 mmol/L, 1-h glucose ≥10.0 mmol/L, 2-h glucose ≥8.5 mmol/L; one abnormal result sufficient).
|
After 24th gestational weeks, about 4 months
|
|
Ruptured uterus
Periodo de tiempo: During delivery
|
Rupture of maternal uterus confirmed by laparotomy.
|
During delivery
|
|
Placental abruption
Periodo de tiempo: After 20th gestational weeks till delivery, about 5 months
|
Abruption of a normally positioned placenta before delivery, diagnosed by clinical symptoms, ultrasound, fetal heart monitoring, or laboratory tests.
|
After 20th gestational weeks till delivery, about 5 months
|
|
Postpartum hemorrhage
Periodo de tiempo: Within 24h after delivery
|
Postpartum bleeding volume ≥500 mL.
|
Within 24h after delivery
|
|
Hepatic diseases
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Hepatitis-B/C/E virus infection, acute fatty liver disease, or severe hepatitis.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Hematological diseases
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Iron-deficiency anemia, thalassemia, hemophilia, idiopathic thrombocytopenic purpura, aplastic anemia, or disseminated intravascular coagulation.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Gynecological diseases
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Uterine fibroids, ovarian cyst, cervical carcinoma, pelvic inflammation, or ovarian carcinoma.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Respiratory diseases
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Pneumonia, bronchitis, asthma or pulmonary tuberculosis.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Thyroid disease
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Hyperthyroidism or hypothyroidism.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
ICU admission
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Admission to intensive care unit.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Maternal death
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Maternal death.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Macrosomia
Periodo de tiempo: within 1 month after delivery
|
Birth weight >4000 g.
|
within 1 month after delivery
|
|
Infant of low-birth weight
Periodo de tiempo: within 1 month after delivery
|
Birth weight <2500 g.
|
within 1 month after delivery
|
|
Neonatal ICU admission
Periodo de tiempo: Within 1 month after delivery
|
Admission to neonatal intensive care unit.
|
Within 1 month after delivery
|
|
Neonatal death
Periodo de tiempo: Within 1 month after delivery
|
Neonatal death.
|
Within 1 month after delivery
|
|
Large for gestational age
Periodo de tiempo: Within 1 month after delivery
|
Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.
|
Within 1 month after delivery
|
|
Small for gestational age
Periodo de tiempo: Within 1 month after delivery
|
Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.
|
Within 1 month after delivery
|
|
Neonatal defect
Periodo de tiempo: Within 1 month after delivery
|
Neonatal defect.
|
Within 1 month after delivery
|
|
Maternal adverse outcomes
Periodo de tiempo: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
There occurred one or more of preeclampsia, eclampsia, ICP, placenta previa, gestational diabetes, ruptured uterus, placental abruption, postpartum hemorrhage, hepatic diseases, hematological diseases, gynecological diseases, respiratory diseases, thyroid disease, ICU admission, or maternal death.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Neonatal adverse outcomes
Periodo de tiempo: Within 1 month after delivery
|
There occurred one or more of macrosomia, low-birth weight, neonatal ICU admission, neonatal death, large for gestational age, small for gestational age, or neonatal defect.
|
Within 1 month after delivery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xin Sun, Doctor, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2015
Finalización primaria (Actual)
1 de diciembre de 2016
Finalización del estudio (Actual)
1 de marzo de 2017
Fechas de registro del estudio
Enviado por primera vez
24 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2017
Publicado por primera vez (Actual)
16 de mayo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GWG-China-2016
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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