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OpenTrials
Completed

NCT Number: NCT04116268

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Universiti Malaysia Sarawak

Kuching, Sarawak, 94300, Malaysia

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Number of participants who develop pregnancy-induced hypertension

    Time frame: 9 months

  2. Number of neonates who require neonatal intensive care unit admission

    Time frame: 9 months

  3. Number of participants who develop pre-eclampsia

    Time frame: 9 months

  4. Number of participants who require primary caesarian section

    Time frame: 9 months

  5. Gestational age at delivery

    Time frame: 9 months

  6. Number of stillbirth

    Time frame: 9 months

  7. Number of preterm delivery

    Time frame: 9 months

  8. Number of macrosomia at delivery

    Time frame: 9 months

    Birth weight more than 4000g

  9. Number of low birth weight at delivery

    Time frame: 9 months

    Birth weight less than 2500g

  10. Birth weight

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

University Malaysia Sarawak

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2019
Registry last updated
Oct 10, 2019

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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