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Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women

Completed
Conditions
Gestational Weight Gain
Registration Number
NCT03154268
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
10422
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ICPAfter 14th gestational weeks till delivery, about 6 months

Intrahepatic cholestasis of pregnancy.

Neonatal defectWithin 1 month after delivery

Neonatal defect.

Gestational diabetesAfter 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).

Hematological diseasesDuring 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.

Placenta previaDuring pregnancy till delivery

Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.

Thyroid diseaseDuring pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year

Hyperthyroidism or hypothyroidism.

ICU admissionDuring pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year

Admission to intensive care unit.

Macrosomiawithin 1 month after delivery

Birth weight \>4000 g.

Infant of low-birth weightwithin 1 month after delivery

Birth weight \<2500 g.

PreeclampsiaAfter 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.

EclampsiaAfter 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.

Ruptured uterusDuring delivery

Rupture of maternal uterus confirmed by laparotomy.

Placental abruptionAfter 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.

Postpartum hemorrhageWithin 24h after delivery

Postpartum bleeding volume ≥500 mL.

Hepatic diseasesDuring 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.

Gynecological diseasesDuring 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.

Respiratory diseasesDuring pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year

Pneumonia, bronchitis, asthma or pulmonary tuberculosis.

Maternal deathDuring pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year

Maternal death.

Neonatal ICU admissionWithin 1 month after delivery

Admission to neonatal intensive care unit.

Neonatal deathWithin 1 month after delivery

Neonatal death.

Large for gestational ageWithin 1 month after delivery

Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.

Small for gestational ageWithin 1 month after delivery

Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.

Neonatal adverse outcomesWithin 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.

Maternal adverse outcomesDuring 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.

Secondary Outcome Measures
NameTimeMethod
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