- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03154268
Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women (GWGCPW)
11 mai 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Observationnel
Inscription (Réel)
10422
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Preeclampsia
Délai: 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
Délai: 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
Délai: After 14th gestational weeks till delivery, about 6 months
|
Intrahepatic cholestasis of pregnancy.
|
After 14th gestational weeks till delivery, about 6 months
|
Placenta previa
Délai: During pregnancy till delivery
|
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
|
During pregnancy till delivery
|
Gestational diabetes
Délai: 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
Délai: During delivery
|
Rupture of maternal uterus confirmed by laparotomy.
|
During delivery
|
Placental abruption
Délai: 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
Délai: Within 24h after delivery
|
Postpartum bleeding volume ≥500 mL.
|
Within 24h after delivery
|
Hepatic diseases
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: within 1 month after delivery
|
Birth weight >4000 g.
|
within 1 month after delivery
|
Infant of low-birth weight
Délai: within 1 month after delivery
|
Birth weight <2500 g.
|
within 1 month after delivery
|
Neonatal ICU admission
Délai: Within 1 month after delivery
|
Admission to neonatal intensive care unit.
|
Within 1 month after delivery
|
Neonatal death
Délai: Within 1 month after delivery
|
Neonatal death.
|
Within 1 month after delivery
|
Large for gestational age
Délai: 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
Délai: 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
Délai: Within 1 month after delivery
|
Neonatal defect.
|
Within 1 month after delivery
|
Maternal adverse outcomes
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Xin Sun, Doctor, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2015
Achèvement primaire (Réel)
1 décembre 2016
Achèvement de l'étude (Réel)
1 mars 2017
Dates d'inscription aux études
Première soumission
24 mars 2017
Première soumission répondant aux critères de contrôle qualité
11 mai 2017
Première publication (Réel)
16 mai 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
16 mai 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 mai 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GWG-China-2016
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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