Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women (GWGCPW)
2017年5月11日 更新者：Jing Tan、West China Hospital
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.
調査の概要
状態
完了
条件
研究の種類
観察的
入学 (実際)
10422
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
サンプリング方法
非確率サンプル
調査対象母集団
Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preeclampsia
時間枠：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.
|
After 20th gestational weeks till delivery, about 5 months
|
|
Eclampsia
時間枠：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.
|
After 20th gestational weeks till delivery, about 5 months
|
|
ICP
時間枠：After 14th gestational weeks till delivery, about 6 months
|
Intrahepatic cholestasis of pregnancy.
|
After 14th gestational weeks till delivery, about 6 months
|
|
Placenta previa
時間枠：During pregnancy till delivery
|
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
|
During pregnancy till delivery
|
|
Gestational diabetes
時間枠：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).
|
After 24th gestational weeks, about 4 months
|
|
Ruptured uterus
時間枠：During delivery
|
Rupture of maternal uterus confirmed by laparotomy.
|
During delivery
|
|
Placental abruption
時間枠：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.
|
After 20th gestational weeks till delivery, about 5 months
|
|
Postpartum hemorrhage
時間枠：Within 24h after delivery
|
Postpartum bleeding volume ≥500 mL.
|
Within 24h after delivery
|
|
Hepatic diseases
時間枠：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.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Hematological diseases
時間枠：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.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Gynecological diseases
時間枠：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.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Respiratory diseases
時間枠：During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Pneumonia, bronchitis, asthma or pulmonary tuberculosis.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Thyroid disease
時間枠：During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Hyperthyroidism or hypothyroidism.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
ICU admission
時間枠：During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Admission to intensive care unit.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Maternal death
時間枠：During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
Maternal death.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Macrosomia
時間枠：within 1 month after delivery
|
Birth weight >4000 g.
|
within 1 month after delivery
|
|
Infant of low-birth weight
時間枠：within 1 month after delivery
|
Birth weight <2500 g.
|
within 1 month after delivery
|
|
Neonatal ICU admission
時間枠：Within 1 month after delivery
|
Admission to neonatal intensive care unit.
|
Within 1 month after delivery
|
|
Neonatal death
時間枠：Within 1 month after delivery
|
Neonatal death.
|
Within 1 month after delivery
|
|
Large for gestational age
時間枠：Within 1 month after delivery
|
Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.
|
Within 1 month after delivery
|
|
Small for gestational age
時間枠：Within 1 month after delivery
|
Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.
|
Within 1 month after delivery
|
|
Neonatal defect
時間枠：Within 1 month after delivery
|
Neonatal defect.
|
Within 1 month after delivery
|
|
Maternal adverse outcomes
時間枠：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.
|
During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
|
|
Neonatal adverse outcomes
時間枠：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.
|
Within 1 month after delivery
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Xin Sun, Doctor、Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年1月1日
一次修了 (実際)
2016年12月1日
研究の完了 (実際)
2017年3月1日
試験登録日
最初に提出
2017年3月24日
QC基準を満たした最初の提出物
2017年5月11日
最初の投稿 (実際)
2017年5月16日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月16日
QC基準を満たした最後の更新が送信されました
2017年5月11日
最終確認日
2017年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。