Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

NCT03154268 | Completed DMC

• 1 other identifier: GWG-China-2016
• Study Type: observational
• Target: 10,422
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Gestational Weight Gain

Keywords

Gestational weight gain; Chinese pregnant women; Retrospective longitudinal study; China; IOM guideline; Adverse outcome; Model

Outcome Measures

Primary Outcomes (24)

• 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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• West China Second University Hospital: collaborator

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xin Sun, Doctor

  Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chinese Evidence-based Medicine Center

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: May 16, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05