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Optimizing GWG in Obese Pregnant Women: A Nationwide Real-World Study Using the U.S. Natality Cohort

NCT07796815 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1600000

Last updated 2026-09-01

No results posted yet for this study

Summary

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

Conditions

  • Pregnancy in Obesity
  • Gestational Weight Gain

Interventions

BEHAVIORAL

Gestational Weight Gain

Total gestational weight gain, calculated as the difference between maternal weight at delivery and pre-pregnancy weight. Categorized into eight prespecified clinical intervals ranging from weight loss (\<0 kg) to excessive gain (≥16.0 kg), with the 5.0-9.0 kg interval (2009 IOM guideline for obese individuals) serving as the reference category.

Sponsors & Collaborators

  • Shanghai First Maternal and Infant Health Hospital affiliated to Tongji University Medical School

    lead OTHER

Principal Investigators

  • Hao Ying, MD & PhD · Shanghai First Maternity and Infant Hospital, School of Medicine, Tongji University, Shanghai, P.R. China

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07796815 on ClinicalTrials.gov