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Completed

NCT Number: NCT04216485

Lifestyle Intervention in Pregnant Women With PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gestational Diabetes Glucose Metabolism Disorders Gonadal Disorders Metabolic Diseases Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Obstetrics and Gynecology Hospital,Capital Medical University

Beijing, 100026, China

About this study

A randomized controlled trial in PCOS pregnant women will be initiated at 8-12 weeks of gestation util delivery. Participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). The intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. The primary outcome will be GWG and secondary outcome will be the incidence of GDM.

Our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with PCOS will decrease GWG and reduce the incidence of GDM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • gestational age between 8 and 12 weeks of gestation, pre-pregnancy BMI≥25 (kg/m2)
  • age ≥18 years, and a singleton pregnancy.

Exclusion criteria

  • patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder
  • gestational weeks ≥ 13
  • age <18 years
  • multiple pregnancy
  • uterine malformation
  • or physical restriction that prevents exercise.

Treatment and study plan

Intensive lifestyle intervention

Behavioral

Dietary intervention combined with healthy lifestyle counseling

Standard Care

Behavioral

Standard prenatal care on diet, nutrition and physical activity

Primary outcomes

  1. Gestational weight gain

    Time frame: From date of randomization until the date of delivery, assessed up to 9 months

Secondary outcomes

  1. Incidence of Gestational Diabetes Mellitus

    Time frame: From enrollment to 24-28 weeks of gestation

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Intensive Lifestyle Intervention on Gestational Weight Gain and Development of Gestational Diabetes Mellitus in Overweight/Obese Pregnant Women With a History of Polycystic Ovarian Syndrome

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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