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The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers

U

University Malaysia Sarawak

Status

Completed

Conditions

Obesity

Study type

Observational

Funder types

Other

Identifiers

NCT04116268
F05/SpGS/1548/2017

Details and patient eligibility

About

The participants are divided into subjects or controls based on the BMI taken during the first trimester of pregnancy upon recruitment. Participants with a BMI of ≥23kg/m2 were recruited as subjects (labelled as obese group) and those with BMI of 18.5-23kg/m2 were recruited as controls. Total gestational weight gain was calculated based on the difference between third trimester weight and first trimester weight. All participants who fulfilled the inclusion and exclusion criteria were recruited after informed consent. Demographic data of all participants were recorded. At first trimester, the participants' weight and height were recorded for calculation of BMI. At every trimester visit, the following were recorded: i) blood pressure using sphygmomanometer after 15 minutes of rest ii) mid-stream urine for presence of proteinuria iii) weight. The participants were followed up until the point of delivery. Occurrence of adverse pregnancy outcome, fetal outcome, and birth weight were documented. The pregnancy outcomes measured in this study included the need of primary caesarian section, the occurrence of pregnancy-induced hypertension (PIH), pre-eclampsia, and gestational age at delivery. The neonatal outcomes measured in this study included neonatal intensive care unit (NICU) admission, stillbirth, preterm delivery, occurrence of macrosomia and low birth weight, and neonatal birth weight.

Enrollment

225 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • First trimester of pregnancy
  • Aged 18 years or older
  • Able to come for follow up at least once per trimester

Exclusion criteria

  • Underlying diabetes mellitus
  • Gestational diabetes mellitus diagnosed via OGTT
  • Known genetic disorders affecting growth at time of recruitment
  • Known congenital anomalies at time of recruitment
  • Conceived via artificial insemination
  • Hepatitis B/C/HIV infection

Trial design

225 participants in 2 patient groups

Obesity
Description:
BMI \>23kg/m2
Control
Description:
BMI 18-22.9kg/m2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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