Clinical trial NCT04116268: The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
Official title: The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University Malaysia Sarawak
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant during first trimester

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who develop pregnancy-induced hypertension
timeFrame: 9 months
measure: Number of neonates who require neonatal intensive care unit admission
timeFrame: 9 months
measure: Number of participants who develop pre-eclampsia
timeFrame: 9 months
measure: Number of participants who require primary caesarian section
timeFrame: 9 months
measure: Gestational age at delivery
timeFrame: 9 months
measure: Number of stillbirth
timeFrame: 9 months
measure: Number of preterm delivery
timeFrame: 9 months
measure: Number of macrosomia at delivery
timeFrame: 9 months
measure: Number of low birth weight at delivery
timeFrame: 9 months
measure: Birth weight
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kuching
country: Malaysia
facility: Universiti Malaysia Sarawak
state: Sarawak
Study officials:
affiliation: University Malaysia Sarawak
name: Huai Heng Loh
role: PRINCIPAL_INVESTIGATOR
References: