Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women (GWGCPW)

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.

Study Overview

• Status: Completed
• Conditions: Gestational Weight Gain

• Study Type: Observational
• Enrollment (Actual): 10422

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: West China Second University Hospital
• Investigators: Principal Investigator: Xin Sun, Doctor, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: China; Gestational weight gain; Model; Chinese pregnant women; Adverse outcome; Retrospective longitudinal study; IOM guideline
• Additional Relevant MeSH Terms: Body Weight Changes; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: GWG-China-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No