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Completed

NCT Number: NCT03154268

Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

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.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • West China Second University Hospital

Registry information

Acronym: GWGCPW

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 16, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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