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

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ClinicalTrials.gov Identifier: NCT03154268
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
West China Second University Hospital
Information provided by (Responsible Party):
Jing Tan, West China Hospital

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.

Condition or disease
Gestational Weight Gain

Study Type : Observational
Actual Enrollment : 10422 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight




Primary Outcome Measures :
  1. Preeclampsia [ Time Frame: After 20th gestational weeks till delivery, about 5 months ]
    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.

  2. Eclampsia [ Time Frame: After 20th gestational weeks till delivery, about 5 months ]
    Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.

  3. ICP [ Time Frame: After 14th gestational weeks till delivery, about 6 months ]
    Intrahepatic cholestasis of pregnancy.

  4. Placenta previa [ Time Frame: During pregnancy till delivery ]
    Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.

  5. Gestational diabetes [ Time Frame: After 24th gestational weeks, about 4 months ]
    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).

  6. Ruptured uterus [ Time Frame: During delivery ]
    Rupture of maternal uterus confirmed by laparotomy.

  7. Placental abruption [ Time Frame: After 20th gestational weeks till delivery, about 5 months ]
    Abruption of a normally positioned placenta before delivery, diagnosed by clinical symptoms, ultrasound, fetal heart monitoring, or laboratory tests.

  8. Postpartum hemorrhage [ Time Frame: Within 24h after delivery ]
    Postpartum bleeding volume ≥500 mL.

  9. Hepatic diseases [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Hepatitis-B/C/E virus infection, acute fatty liver disease, or severe hepatitis.

  10. Hematological diseases [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Iron-deficiency anemia, thalassemia, hemophilia, idiopathic thrombocytopenic purpura, aplastic anemia, or disseminated intravascular coagulation.

  11. Gynecological diseases [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Uterine fibroids, ovarian cyst, cervical carcinoma, pelvic inflammation, or ovarian carcinoma.

  12. Respiratory diseases [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Pneumonia, bronchitis, asthma or pulmonary tuberculosis.

  13. Thyroid disease [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Hyperthyroidism or hypothyroidism.

  14. ICU admission [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Admission to intensive care unit.

  15. Maternal death [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    Maternal death.

  16. Macrosomia [ Time Frame: within 1 month after delivery ]
    Birth weight >4000 g.

  17. Infant of low-birth weight [ Time Frame: within 1 month after delivery ]
    Birth weight <2500 g.

  18. Neonatal ICU admission [ Time Frame: Within 1 month after delivery ]
    Admission to neonatal intensive care unit.

  19. Neonatal death [ Time Frame: Within 1 month after delivery ]
    Neonatal death.

  20. Large for gestational age [ Time Frame: Within 1 month after delivery ]
    Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.

  21. Small for gestational age [ Time Frame: Within 1 month after delivery ]
    Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.

  22. Neonatal defect [ Time Frame: Within 1 month after delivery ]
    Neonatal defect.

  23. Maternal adverse outcomes [ Time Frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year ]
    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.

  24. Neonatal adverse outcomes [ Time Frame: Within 1 month after delivery ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154268


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

Responsible Party: Jing Tan, Chinese Evidence-based Medicine Center, West China Hospital
ClinicalTrials.gov Identifier: NCT03154268     History of Changes
Other Study ID Numbers: GWG-China-2016
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jing Tan, West China Hospital:
Gestational weight gain
Chinese pregnant women
Retrospective longitudinal study
China
IOM guideline
Adverse outcome
Model

Additional relevant MeSH terms:
Body Weight
Weight Gain
Signs and Symptoms
Body Weight Changes