Trans Abdominal UltrasoundNCT04687891
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.
An observational study of Trans Abdominal Ultrasound and Transvaginal Ultrasound, run by Cairo University at 1 site in Egypt.
Trial summary
aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Trans Abdominal Ultrasound, Transvaginal Ultrasound, Lower Uterine Segment Thickness
- What is being tested?
- transabdominal ultrasound and transvaginal ultrasound
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 31 Dec 2020
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 130 pregnant women at term with a previous one cesarean section admitted for an elective cesarean delivery will be enrolled. LUS thickness will be measured using both TVS and TAS prior to the cesarean. The actual thickness of the LUS will be measured using a sterile metal ruler before the neonate had been delivered.
Who may be able to join
- Age (20:40 years old).
- Women at term (37:40 weeks).
- With singleton pregnancy.
- Presenting by vertex (cephalic presentation).
- Having adequate liquor.
- Previous delivered by cesarean delivery one time.
Who cannot join
- Fetal malformations, e.g fetal hydrops.
- Uterine malformations, e.g bicornuate uterus.
- Placental malformations, e.g placenta praevia, placenta accrete.
- Uterine surgery is other than a cesarean, e.g myomectomy.
- Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation).
- Obese patients (BMI >30 kg/m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.
aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery.
Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery.
Study question: considering transabdominal \& transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?
- Being tested
- transabdominal ultrasound and transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transabdominal ultrasound and transvaginal ultrasoundDiagnostic test
Within a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder.
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy test for measuring
The accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to actual thickness of LUS measured with manual caliper at cesarean delivery.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 May 2020
- Primary completion30 Dec 2020
- Study completion31 Dec 2020
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 Trans Abdominal UltrasoundStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed nagy shaker ramadan, Cairo University
- Investigators
- Mohammed A Taymour, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687891
- Sponsor's protocol ID
- 35/2020
- Status last verified
- Jul 2021
- First submitted
- 24 Dec 2020
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nagy Afifi A, Ahmed Taymour M, Mamdouh El-Khayat W. Transabdominal versus transvaginal ultrasound to assess the thickness of lower uterine segment at term in women with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:145-151. doi: 10.1016/j.ejogrb.2022.01.027. Epub 2022 Feb 7.
PubMed 35203047
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.
- ClinicalTrials.gov ID
- NCT04687891
- Acronym / sponsor ID
- 35/2020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Dec 2020 (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.
aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery.
Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery.
Study question: considering transabdominal \& transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 130 pregnant women at term with a previous one cesarean section admitted for an elective cesarean delivery will be enrolled. LUS thickness will be measured using both TVS and TAS prior to the cesarean. The actual thickness of the LUS will be measured using a sterile metal ruler before the neonate had been delivered.
Key inclusion criteria (6 listed)
- Age (20:40 years old).
- Women at term (37:40 weeks).
- With singleton pregnancy.
- Presenting by vertex (cephalic presentation).
- Having adequate liquor.
Key exclusion criteria (6 listed)
- Fetal malformations, e.g fetal hydrops.
- Uterine malformations, e.g bicornuate uterus.
- Placental malformations, e.g placenta praevia, placenta accrete.
- Uterine surgery is other than a cesarean, e.g myomectomy.
- Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation).
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 |
|---|---|---|
| transabdominal ultrasound and transvaginal ultrasoundWithin a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder. | Diagnostic test | – |
Primary outcome
accuracy test for measuring
Time frame: 1 week
The accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to actual thickness of LUS measured with manual caliper at cesarean delivery.
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 29 Jul 2021.
- Derived from this study: PubMed 35203047Nagy Afifi A, Ahmed Taymour M, Mamdouh El-Khayat W. Transabdominal versus transvaginal ultrasound to assess the thickness of lower uterine segment at term in women with previous cesarean section. Eur J Obstet Gynecol Reprod Biol. 2022 Apr;271:145-151. doi: 10.1016/j.ejogrb.2022.01.027. Epub 2022 Feb 7.
- Individual participant dataSharing planned: Undecided
Related trials for Trans Abdominal Ultrasound
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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.
Mohammed A Taymour, MD principal investigator
Cairo University
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 Trans Abdominal Ultrasound and Transvaginal Ultrasound, run by Cairo University at 1 site in Egypt.
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 6 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 29 Jul 2021. 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 Egypt. 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?
accuracy test for measuring (time frame: 1 week). 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 NCT04687891, 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 29 Jul 2021.