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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04116268
Enrollment
225
Registered
2019-10-04
Start date
2017-10-01
Completion date
2019-09-30
Last updated
2019-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

None listed

Sponsors

University Malaysia Sarawak
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who develop pregnancy-induced hypertension9 months
Number of neonates who require neonatal intensive care unit admission9 months
Number of participants who develop pre-eclampsia9 months
Number of participants who require primary caesarian section9 months
Gestational age at delivery9 months
Number of stillbirth9 months
Number of preterm delivery9 months
Number of macrosomia at delivery9 monthsBirth weight more than 4000g
Number of low birth weight at delivery9 monthsBirth weight less than 2500g
Birth weight9 months

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026