PregnancyNCT03380637
Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants
An observational study of Pregnancy, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- ultrasound
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 13 Oct 2016to 10 Oct 2017
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study population are term pregnants posted for elective lower segment cesarean section and non-pregnant patients posted for elective surgeries in PGIMER.
Who may be able to join
None listed.
Who cannot join
- Gastrointestinal pathology
- On any medication delaying gastric motility
- Systemic lupus erythematosis
- Diabetes mellitus
- Gestational diabetes
- Hypothyroidism Those who were not willing to give consent
About this study
Official title: Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.
This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.
Read the detailed description
There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.
The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.
- Conditions
- Pregnancy
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundOther
Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)
| Study group | Role | What they receive |
|---|---|---|
| Pregnant and non-pregnant females | The pregnant females posted for elective lower segment cesarean section and non-pregnant females posted for elective surgeries are scanned by ultrasound in the pre recovery room. The visibility of the gastric antrum is assessed. The qualitative and quantitative assessment is made and is compared. Receives: Other: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility
The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.
Measured: October 2016 to October 2017
Secondary outcomes (2)
Qualitative assessment of Gastric antrum
The qualitative grading is derived and is compared in the pregnants and non-pregnants.
Measured: October 2016 to October 2017
Quantitative assessment of Gastric Antrum
The quantitative data is obtained from the derived formulae and is compared in pregnants and non-pregnants.
Measured: October 2016 to October 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start13 Oct 2016
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Snigdha Bellapukonda, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Snigdha Bellapukonda, MBBS, Principal investigator, Post graduate institute of medical education and researchh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380637
- Sponsor's protocol ID
- 10565/PG-2Trg/2015/173-74
- Status last verified
- Dec 2017
- First submitted
- 15 Dec 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ultrasound for comparison of Gastric volume in pregnants undergoing Elective Lower Segment Cesarean Section and non-pregnant females undergoing elective surgeries.
Publications
Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
PubMed 21596885
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.
- ClinicalTrials.gov ID
- NCT03380637
- Acronym / sponsor ID
- 10565/PG-2Trg/2015/173-74
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 21 Dec 2017 (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.
This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.
Detailed description
There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.
The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant and non-pregnant females | – | Other: ultrasoundThe pregnant females posted for elective lower segment cesarean section and non-pregnant females posted for elective surgeries are scanned by ultrasound in the pre recovery room. The visibility of the gastric antrum is assessed. The qualitative and quantitative assessment is made and is compared. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population are term pregnants posted for elective lower segment cesarean section and non-pregnant patients posted for elective surgeries in PGIMER.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Gastrointestinal pathology
- On any medication delaying gastric motility
- Systemic lupus erythematosis
- Diabetes mellitus
- Gestational diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundSonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA) | Other | Pregnant and non-pregnant females |
Primary outcome
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility
Time frame: October 2016 to October 2017
The effectiveness is stated in terms of percentage visibility and compared in pregnants and non-pregnants.
2 secondary outcomes
Qualitative assessment of Gastric antrum
Time frame: October 2016 to October 2017
Quantitative assessment of Gastric Antrum
Time frame: October 2016 to October 2017
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 21 Dec 2017.
- Background: PubMed 21596885Perlas A, Davis L, Khan M, Mitsakakis N, Chan VW. Gastric sonography in the fasted surgical patient: a prospective descriptive study. Anesth Analg. 2011 Jul;113(1):93-7. doi: 10.1213/ANE.0b013e31821b98c0. Epub 2011 May 19.
- Individual participant dataSharing planned: Yes. Ultrasound for comparison of Gastric volume in pregnants undergoing Elective Lower Segment Cesarean Section and non-pregnant females undergoing elective surgeries.
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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.
Snigdha Bellapukonda, MBBS principal investigator
Post graduate institute of medical education and researchh
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 0 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 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Effectiveness of ultrasound in pregnants and non-pregnants in terms of visibility (time frame: October 2016 to October 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03380637, which also lists 1 linked publication.
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 21 Dec 2017.