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Pregnancy Butler for gestational weight gain management

Randomized control study for business and clinical validation of Philips Pregnancy Butler

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014647
Enrollment
Unknown
Registered
2018-01-26
Start date
2017-12-18
Completion date
Unknown
Last updated
2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gestational weight gain

Interventions

intervention group:4 times face to face nutrition consultation with Apps for weight control using in between
Control group:Without face to face nutrition consultation

Sponsors

Beijing New Century Women's and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: For clinical validation the inclusion criteria include: 1. Having attend business validation; 2. Willing to attend clinical test; 3. Purchased pregnancy package in Beijing New Century Women's and Children's Hospital at gestational week 11-13; 4. Pregnant with one fetus with no known anomalies; 5. Not enrolled in other research studies. For business validation the inclusion criteria include: 1. Pregnant women with age between 18-45 years old; 2. Pregnant with one fetus with no known anomalies; 3. Living in Beijing and able to speak and read Chinese; 4. Willing to attend the test; 5. Having smart phone with IOS; 6. Willing to perform the examination for pregnancy determination at Beijing New Century Women's and Children's Hospital at gestational week 5-8.

Exclusion criteria

Exclusion criteria: For clinical validation the exclusion criteria include: 1. Having complications before and during pregnancy that the Principal Investigator (PI) believes may affect body weight gain, e.g. diabetes, high blood pressure with medication, thyroid diseases et al.; 2. Have any conditions or factors that the Principal Investigator (PI) believes may affect fetus development, e.g. fetal growth restriction, fetal distress, umbilical cord abnormalities, and abnormal placenta et al.; 3. Having complications during pregnancy that the Principal Investigator (PI) believes may need special care or even to be cared in hospital, e.g. eclampsia and preeclampsia et al.; 4. Pregnant with more than one fetus; 5. Ectopic pregnancy; 6. Preterm labor (less than 37 weeks). For business validation the exclusion criteria include: 1. Those who haven't perform pregnancy determination examination at Beijing New Century Women's and Children's Hospital at gestational week 5-8, and come to purchase the antenatal care package with/without nutrition; 2. consultation package at gestational week 11-13.

Design outcomes

Primary

MeasureTime frame
weight;

Secondary

MeasureTime frame
fasting blood glucose;HbA1C;oral glucose tolerance test;baby birth weight;method of delivery;quality of life;nutrition awareness;food frequency questionnaire;exercise questionnaire;

Countries

China

Contacts

Public ContactZhang, Dongtao

Beijing New Century Women's and Children's Hospital

dongtao.zhang@ncich.com.cn+86 13693515116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026