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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04116268
• Other study ID #: F05/SpGS/1548/2017
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: University Malaysia Sarawak
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Malaysia	Universiti Malaysia Sarawak	Kuching	Sarawak

Sponsors (1)

Lead Sponsor	Collaborator
University Malaysia Sarawak

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who develop pregnancy-induced hypertension		9 months
Primary	Number of neonates who require neonatal intensive care unit admission		9 months
Primary	Number of participants who develop pre-eclampsia		9 months
Primary	Number of participants who require primary caesarian section		9 months
Primary	Gestational age at delivery		9 months
Primary	Number of stillbirth		9 months
Primary	Number of preterm delivery		9 months
Primary	Number of macrosomia at delivery	Birth weight more than 4000g	9 months
Primary	Number of low birth weight at delivery	Birth weight less than 2500g	9 months
Primary	Birth weight		9 months