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

NCT04116268 | Completed

• 1 other identifier: F05/SpGS/1548/2017
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (10)

• Number of participants who develop pregnancy-induced hypertension

  9 months

• Number of neonates who require neonatal intensive care unit admission

  9 months

• Number of participants who develop pre-eclampsia

  9 months

• Number of participants who require primary caesarian section

  9 months

• Gestational age at delivery

  9 months

• Number of stillbirth

  9 months

• Number of preterm delivery

  9 months

• Number of macrosomia at delivery

  Birth weight more than 4000g

  9 months

• Number of low birth weight at delivery

  Birth weight less than 2500g

  9 months

• Birth weight

  9 months

Study Arms (2)

Obesity

BMI \>23kg/m2

Control

BMI 18-22.9kg/m2

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant during first trimester

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Malaysia Sarawak: lead

Study Sites (1)

Universiti Malaysia Sarawak

Kuching, Sarawak, 94300, Malaysia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Huai Heng Loh

  University Malaysia Sarawak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 4, 2019
• Study Start: October 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: September 30, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

MY (1)