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Lifestyle Intervention in Pregnant Women With PCOS

NCT04216485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2021-07-28

No results posted yet for this study

Summary

Polycystic ovarian syndrome (PCOS) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. Importantly, a number of adverse outcome are seen in pregnancies complicated by PCOS, including gestational diabetes mellitus (GDM), preeclampsia and miscarriage. However, optimal management of PCOS complicated pregnancy is not known. This study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with PCOS could reduce gestational weight gain (GWG) and incidence of GDM.

Conditions

  • Polycystic Ovary Syndrome
  • Overweight and Obesity
  • Gestational Diabetes

Interventions

BEHAVIORAL

Intensive Lifestyle Intervention

Dietary intervention combined with healthy lifestyle counseling

BEHAVIORAL

Standard Care

Standard prenatal care on diet, nutrition and physical activity

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Guanghui Li, MD, PhD · Beijing Obstetrics and Gynecology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • China

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 NCT04216485 on ClinicalTrials.gov