NCT07796815Completed
Optimizing GWG in Obese Pregnant Women: A Nationwide Real-World Study Using the U.S. Natality Cohort
Optimizing Gestational Weight Gain in Obese Pregnant Women: A Nationwide Real-World Study Using the U.S. Natality Cohort
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
The goal of this observational study is to find out which amount of weight gain during pregnancy is safest for women with obesity and their babies. Current guidelines recommend the same weight gain target (5 to 9 kg) for all women with obesity. However, obesity has different levels of severity. The same target may not work well for everyone. Researchers will look at health data from about 10 million U.S. birth records between 2023 and 2025. They will focus on women aged 18 to 45 who had a single baby at full term (37 to 41 weeks) and had obesity before pregnancy. All women in this study started prenatal care in their first 3 months of pregnancy. The study divides total pregnancy weight gain into 8 different ranges. Then, it checks for maternal and newborn health problems. Serious problems include stays in the intensive care unit (ICU) or blood transfusions. Moderate problems include high blood pressure during pregnancy, diabetes, or babies born too large or too small. By comparing weight gain ranges across three obesity classes, this study aims to find specific target weight ranges for each class. The ultimate goal is to lower the risk of both severe and moderate pregnancy complications for mothers and their newborns
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1600000 (actual)
- First submitted
- 27 Aug 2026
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School
- Diseases
- Obesity
- NCT number
- NCT07796815
What you commit to
- Study type: Observational
- Participants enrolled: 1600000
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Missing data on pre-pregnancy weight, delivery weight, or birth weight. Implausible gestational weight gain (GWG) values: \< -10 kg or \> 50 kg. Unknown mode of delivery or documented prior cesarean section.
Who the study is looking for
- Nulliparous or multiparous individuals aged 18 to 45 years at delivery. Singleton, live-born, term pregnancy (37 to 41 completed weeks of gestation). Pre-pregnancy obesity, defined as body mass index (BMI) ≥ 30.0 kg/m². Initiation of prenatal care during the first trimester (months 1-3 of pregnancy).
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Vital Statistics System (NVSS) - United States Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.