Gestational Weight GainGWGCPWNCT03154268
Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women
An observational study of Gestational Weight Gain, run by West China Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Weight Gain
- How many people
- 10,422 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
- Conditions
- Gestational Weight Gain
- Keywords
- Gestational weight gain, Chinese pregnant women, Retrospective longitudinal study, China, IOM guideline, Adverse outcome, Model
- Medical subject headings
- Gestational Weight Gain
What is being measured
The primary outcome is the main question the study is designed to answer.
Preeclampsia
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.
Measured: After 20th gestational weeks till delivery, about 5 months
Eclampsia
Tonic-clonic seizures (convulsions) in preeclampsia patients, including convulsions and coma, not due to pre-existing or organic brain disorders.
Measured: After 20th gestational weeks till delivery, about 5 months
ICP
Intrahepatic cholestasis of pregnancy.
Measured: After 14th gestational weeks till delivery, about 6 months
Placenta previa
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
Measured: During pregnancy till delivery
Gestational diabetes
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).
Measured: After 24th gestational weeks, about 4 months
Ruptured uterus
Rupture of maternal uterus confirmed by laparotomy.
Measured: During delivery
Placental abruption
Abruption of a normally positioned placenta before delivery, diagnosed by clinical symptoms, ultrasound, fetal heart monitoring, or laboratory tests.
Measured: After 20th gestational weeks till delivery, about 5 months
Postpartum hemorrhage
Postpartum bleeding volume ≥500 mL.
Measured: Within 24h after delivery
Hepatic diseases
Hepatitis-B/C/E virus infection, acute fatty liver disease, or severe hepatitis.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Hematological diseases
Iron-deficiency anemia, thalassemia, hemophilia, idiopathic thrombocytopenic purpura, aplastic anemia, or disseminated intravascular coagulation.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Gynecological diseases
Uterine fibroids, ovarian cyst, cervical carcinoma, pelvic inflammation, or ovarian carcinoma.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Respiratory diseases
Pneumonia, bronchitis, asthma or pulmonary tuberculosis.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Thyroid disease
Hyperthyroidism or hypothyroidism.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
ICU admission
Admission to intensive care unit.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Maternal death
Maternal death.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Macrosomia
Birth weight >4000 g.
Measured: within 1 month after delivery
Infant of low-birth weight
Birth weight <2500 g.
Measured: within 1 month after delivery
Neonatal ICU admission
Admission to neonatal intensive care unit.
Measured: Within 1 month after delivery
Neonatal death
Neonatal death.
Measured: Within 1 month after delivery
Large for gestational age
Neonatal weight, length, or head circumference above the 90th percentile for that gestational age.
Measured: Within 1 month after delivery
Small for gestational age
Neonatal weight, length, or head circumference below the 10th percentile for that gestational age.
Measured: Within 1 month after delivery
Neonatal defect
Neonatal defect.
Measured: Within 1 month after delivery
Maternal adverse outcomes
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.
Measured: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Neonatal adverse outcomes
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.
Measured: Within 1 month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJan 2015
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10,422 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, Jing Tan, West China Hospital
- Investigators
- Xin Sun, Doctor, Principal investigator, Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154268
- Sponsor's protocol ID
- GWG-China-2016
- Acronym
- GWGCPW
- Status last verified
- May 2017
- First submitted
- 24 Mar 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Longitudinal Study of Gestational Weight Gain Among Chinese Pregnant Women
- ClinicalTrials.gov ID
- NCT03154268
- Acronym / sponsor ID
- GWGCPW / GWG-China-2016
- Conditions
- Gestational Weight Gain
- Keywords
- Gestational weight gain, Chinese pregnant women, Retrospective longitudinal study, China, IOM guideline, Adverse outcome, Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,422 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese pregnant women who had deliveries at West China Women and Children's Hospital, Sichuan University
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
ICP
Time frame: After 14th gestational weeks till delivery, about 6 months
Intrahepatic cholestasis of pregnancy.
Placenta previa
Time frame: During pregnancy till delivery
Placenta partially or entirely covered the lower uterine segment diagnosed using antenatal ultrasound.
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).
Ruptured uterus
Time frame: During delivery
Rupture of maternal uterus confirmed by laparotomy.
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.
Postpartum hemorrhage
Time frame: Within 24h after delivery
Postpartum bleeding volume ≥500 mL.
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.
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.
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.
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.
Thyroid disease
Time frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Hyperthyroidism or hypothyroidism.
ICU admission
Time frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Admission to intensive care unit.
Maternal death
Time frame: During pregnancy, delivery or within 42 days of pregnancy termination, an average of 1 year
Maternal death.
Macrosomia
Time frame: within 1 month after delivery
Birth weight >4000 g.
Infant of low-birth weight
Time frame: within 1 month after delivery
Birth weight <2500 g.
Neonatal ICU admission
Time frame: Within 1 month after delivery
Admission to neonatal intensive care unit.
Neonatal death
Time frame: Within 1 month after delivery
Neonatal death.
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.
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.
Neonatal defect
Time frame: Within 1 month after delivery
Neonatal defect.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin Sun, Doctor principal investigator
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Weight Gain, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preeclampsia (time frame: After 20th gestational weeks till delivery, about 5 months). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.