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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116268
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Huai Heng, Loh, University Malaysia Sarawak

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.

Condition or disease
Obesity

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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : September 30, 2019

Group/Cohort
Obesity
BMI >23kg/m2
Control
BMI 18-22.9kg/m2



Primary Outcome Measures :
  1. Number of participants who develop pregnancy-induced hypertension [ Time Frame: 9 months ]
  2. Number of neonates who require neonatal intensive care unit admission [ Time Frame: 9 months ]
  3. Number of participants who develop pre-eclampsia [ Time Frame: 9 months ]
  4. Number of participants who require primary caesarian section [ Time Frame: 9 months ]
  5. Gestational age at delivery [ Time Frame: 9 months ]
  6. Number of stillbirth [ Time Frame: 9 months ]
  7. Number of preterm delivery [ Time Frame: 9 months ]
  8. Number of macrosomia at delivery [ Time Frame: 9 months ]
    Birth weight more than 4000g

  9. Number of low birth weight at delivery [ Time Frame: 9 months ]
    Birth weight less than 2500g

  10. Birth weight [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant during first trimester
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116268


Locations
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Malaysia
Universiti Malaysia Sarawak
Kuching, Sarawak, Malaysia, 94300
Sponsors and Collaborators
University Malaysia Sarawak
Investigators
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Principal Investigator: Huai Heng Loh University Malaysia Sarawak

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Responsible Party: Dr Huai Heng, Loh, Associate Professor Dr., University Malaysia Sarawak
ClinicalTrials.gov Identifier: NCT04116268    
Other Study ID Numbers: F05/SpGS/1548/2017
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms