Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

Gestational Weight Gain Clinical Trial

— GWGCPW  

Official title:

Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03154268
• Other study ID #: GWG-China-2016
• 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
• 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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain

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