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NCT04116268
The Effect of Obesity on Pregnancy and Fetal Outcome in Glucose Tolerant Mothers
trial in Obesity in 225 participants. Completed in 30 September 2019.
31 March 2019
Quick facts
| Lead sponsor | University Malaysia Sarawak |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 225 |
| Start date | 1 October 2017 |
| Primary completion | 31 March 2019 |
| Estimated completion | 30 September 2019 |
| Sites | 1 location across Malaysia |
Conditions studied
- Obesity — all drugs for Obesity →
Sponsor
University Malaysia Sarawak
Who can join
18 and older, female only, with Obesity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04116268
- Europe PMC full search
- ASCO Meeting Library
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Other University Malaysia Sarawak trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04116268 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Malaysia Sarawak
- Last refreshed: 10 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04116268.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing