ObesityNCT04116268
The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
An observational study of Obesity, run by University Malaysia Sarawak at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 225 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant during first trimester
Who may be able to join
- First trimester of pregnancy
- Aged 18 years or older
- Able to come for follow up at least once per trimester
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity | BMI >23kg/m2 | |
| Control | BMI 18-22.9kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop pregnancy-induced hypertension
Measured: 9 months
Number of neonates who require neonatal intensive care unit admission
Measured: 9 months
Number of participants who develop pre-eclampsia
Measured: 9 months
Number of participants who require primary caesarian section
Measured: 9 months
Gestational age at delivery
Measured: 9 months
Number of stillbirth
Measured: 9 months
Number of preterm delivery
Measured: 9 months
Number of macrosomia at delivery
Birth weight more than 4000g
Measured: 9 months
Number of low birth weight at delivery
Birth weight less than 2500g
Measured: 9 months
Birth weight
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Oct 2017
- Primary completion31 Mar 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Malaysia Sarawak
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Huai Heng, Loh, University Malaysia Sarawak
- Investigators
- Huai Heng Loh, Principal investigator, University Malaysia Sarawak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116268
- Sponsor's protocol ID
- F05/SpGS/1548/2017
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
- ClinicalTrials.gov ID
- NCT04116268
- Acronym / sponsor ID
- F05/SpGS/1548/2017
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University Malaysia SarawakUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | –BMI >23kg/m2 |
| Control | – | –BMI 18-22.9kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant during first trimester
Key inclusion criteria (3 listed)
- First trimester of pregnancy
- Aged 18 years or older
- Able to come for follow up at least once per trimester
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who develop pregnancy-induced hypertension
Time frame: 9 months
Number of neonates who require neonatal intensive care unit admission
Time frame: 9 months
Number of participants who develop pre-eclampsia
Time frame: 9 months
Number of participants who require primary caesarian section
Time frame: 9 months
Gestational age at delivery
Time frame: 9 months
Number of stillbirth
Time frame: 9 months
Number of preterm delivery
Time frame: 9 months
Number of macrosomia at delivery
Time frame: 9 months
Birth weight more than 4000g
Number of low birth weight at delivery
Time frame: 9 months
Birth weight less than 2500g
Birth weight
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huai Heng Loh principal investigator
University Malaysia Sarawak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Malaysia Sarawak at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who develop pregnancy-induced hypertension (time frame: 9 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.