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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03154268
Other study ID # GWG-China-2016
Secondary ID
Status Completed
Phase N/A
First received March 24, 2017
Last updated May 11, 2017
Start date January 2015
Est. completion date March 2017

Study information

Verified date May 2017
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 10422
Est. completion date March 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

1. Deliveries between January 2013 and December 2014;

2. Gestational age between 37 weeks or older and less than 42 weeks;

3. Registration with care documents at the first prenatal visit prior to the 15th gestational week;

4. Had at least five follow-up visits until delivery.

Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
West China Hospital West China Second University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary ICP Intrahepatic cholestasis of pregnancy. After 14th gestational weeks till delivery, about 6 months
Primary Placenta previa Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound. During pregnancy till delivery
Primary 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
Primary Ruptured uterus Rupture of maternal uterus confirmed by laparotomy. During delivery
Primary 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
Primary Postpartum hemorrhage Postpartum bleeding volume =500 mL. Within 24h after delivery
Primary 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
Primary 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
Primary 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
Primary Respiratory diseases Pneumonia, bronchitis, asthma or pulmonary tuberculosis. During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Primary Thyroid disease Hyperthyroidism or hypothyroidism. During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Primary ICU admission Admission to intensive care unit. During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Primary Maternal death Maternal death. During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Primary Macrosomia Birth weight >4000 g. within 1 month after delivery
Primary Infant of low-birth weight Birth weight <2500 g. within 1 month after delivery
Primary Neonatal ICU admission Admission to neonatal intensive care unit. Within 1 month after delivery
Primary Neonatal death Neonatal death. Within 1 month after delivery
Primary Large for gestational age Neonatal weight, length, or head circumference above the 90th percentile for that gestational age. Within 1 month after delivery
Primary Small for gestational age Neonatal weight, length, or head circumference below the 10th percentile for that gestational age. Within 1 month after delivery
Primary Neonatal defect Neonatal defect. Within 1 month after delivery
Primary 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
Primary 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
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