Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

11. mai 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

10422

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preeclampsia
Tidsramme: 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
Tidsramme: 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
Tidsramme: After 14th gestational weeks till delivery, about 6 months
Intrahepatic cholestasis of pregnancy.
After 14th gestational weeks till delivery, about 6 months
Placenta previa
Tidsramme: During pregnancy till delivery
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
During pregnancy till delivery
Gestational diabetes
Tidsramme: 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
Tidsramme: During delivery
Rupture of maternal uterus confirmed by laparotomy.
During delivery
Placental abruption
Tidsramme: 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
Tidsramme: Within 24h after delivery
Postpartum bleeding volume ≥500 mL.
Within 24h after delivery
Hepatic diseases
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: within 1 month after delivery
Birth weight >4000 g.
within 1 month after delivery
Infant of low-birth weight
Tidsramme: within 1 month after delivery
Birth weight <2500 g.
within 1 month after delivery
Neonatal ICU admission
Tidsramme: Within 1 month after delivery
Admission to neonatal intensive care unit.
Within 1 month after delivery
Neonatal death
Tidsramme: Within 1 month after delivery
Neonatal death.
Within 1 month after delivery
Large for gestational age
Tidsramme: 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
Tidsramme: 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
Tidsramme: Within 1 month after delivery
Neonatal defect.
Within 1 month after delivery
Maternal adverse outcomes
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

West China Hospital

Samarbeidspartnere

West China Second University Hospital

Etterforskere

  • Hovedetterforsker: Xin Sun, Doctor, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2015

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. mars 2017

Datoer for studieregistrering

Først innsendt

24. mars 2017

Først innsendt som oppfylte QC-kriteriene

11. mai 2017

Først lagt ut (Faktiske)

16. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2017

Sist bekreftet

1. mai 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GWG-China-2016

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Vektøkning i svangerskapet

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Tunisia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere