NCT03154268|CompletedDMC
Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women
GWGCPW
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GWGCPW
Sponsor study identifier
observational
10,422
0 countries
N/A
Study Start
January 2015
Actual (reported)Primary Completion
December 2016
Actual (reported)Study Completion
March 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Actual (reported)December 2016
Actual (reported)March 2017
Actual (reported)March 24, 2017
Actual (reported)May 16, 2017
Actual (reported)Preeclampsia
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
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
Intrahepatic cholestasis of pregnancy.
After 14th gestational weeks till delivery, about 6 months
Placenta previa
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
During pregnancy till delivery
Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
Xin Sun, Doctor
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
10,422 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2017
First Posted
May 16, 2017
Study Start
January 2015
Actual (reported)Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China
Gestational diabetes
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
Rupture of maternal uterus confirmed by laparotomy.
During delivery
Placental abruption
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
Postpartum bleeding volume ≥500 mL.
Within 24h after delivery
Hepatic diseases
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
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
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
Pneumonia, bronchitis, asthma or pulmonary tuberculosis.
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Thyroid disease
Hyperthyroidism or hypothyroidism.
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
ICU admission
Admission to intensive care unit.
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Maternal death
Maternal death.
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Macrosomia
Birth weight \>4000 g.
within 1 month after delivery
Infant of low-birth weight
Birth weight \<2500 g.
within 1 month after delivery
Neonatal ICU admission
Admission to neonatal intensive care unit.
Within 1 month after delivery
Neonatal death
Neonatal death.
Within 1 month after delivery
Large for gestational age
Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.
Within 1 month after delivery
Small for gestational age
Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.
Within 1 month after delivery
Neonatal defect
Neonatal defect.
Within 1 month after delivery
Maternal adverse outcomes
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
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
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
March 2017
Actual (reported)Last Updated
May 16, 2017
Record last verified: 2017-05
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