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

NCT ID: NCT04116268

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-09-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Obesity

BMI \>23kg/m2

No interventions assigned to this group

Control

BMI 18-22.9kg/m2

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Malaysia Sarawak

OTHER

Sponsor Role: lead

Responsible Party

Dr Huai Heng, Loh

Associate Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huai Heng Loh

Role: PRINCIPAL_INVESTIGATOR

University Malaysia Sarawak

Locations

Universiti Malaysia Sarawak

Kuching, Sarawak, Malaysia

Countries

Malaysia

Other Identifiers

F05/SpGS/1548/2017

Identifier Type: -

Identifier Source: org_study_id