Placenta Implantation SiteNCT02765984
Relation of Implantation Site to Placental Site
An observational study of Placenta Implantation Site, run by Cairo University at 1 site in Egypt.
Trial summary
Trans vaginal ultrasound with a partially full bladder will be done at gestational age earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial cavity and the distance between the implantation site and the internal cervical os . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Placenta Implantation Site
- What is being tested?
- Transvaginal ultrasound
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to Dec 2018
- 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: pregnant women at their early trimester with or without cesarean section scar
Who may be able to join
- Single intrauterine pregnancy
- Gestational age less than 10 weeks
Who cannot join
- Any condition distorting uterine cavity as myoma, uterine anomalies.
- Absent fetal pulsations
- Any condition needing termination of early pregnancy as molar pregnancy or severe deteriorating maternal disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Maged
Cairo, 12151
Ahmed Maged, MD, prof.ahmedmaged@gmail.com
Ahmed Shaker, MD
About this study
Official title: Relation of Implantation Site to Placental Site With or Without Cesarean Section Scar
Trans vaginal ultrasound with a partially full bladder will be done at gestational age earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial cavity and the distance between the implantation site and the internal cervical os . Doppler assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue to detect resistance index.
- Conditions
- Placenta Implantation Site
- Being tested
- Transvaginal ultrasound
- Keywords
- implantation site, placental site, Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundDevice
transvaginal ultrasound done before 10 weeks gestational age measuring the distance between the lower end of the hyperechoic trophoblast ring of the gestational sac and the inner cervical os
| Study group | Role | What they receive |
|---|---|---|
| normal placental site | women with normal implantation site at early trimester with normal placental site Receives: Device: Transvaginal ultrasound | |
| Low placental site | women with low implantation site at early trimester with low placental site Receives: Device: Transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between the implantation site and the internal cervical os
Measured: 10 weeks to 40 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start1 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Implantation SiteStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765984
- Sponsor's protocol ID
- 142
- Status last verified
- Mar 2018
- First submitted
- 30 Apr 2016
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Implantation Site to Placental Site With or Without Cesarean Section Scar
- ClinicalTrials.gov ID
- NCT02765984
- Acronym / sponsor ID
- 142
- Conditions
- Placenta Implantation Site
- Keywords
- implantation site, placental site, Doppler
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 May 2016 (estimated)
- 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.
Trans vaginal ultrasound with a partially full bladder will be done at gestational age earlier than 10 weeks to assess the site of intrauterine gestational sac to the endometrial cavity and the distance between the implantation site and the internal cervical os . Doppler assessment of the retrochorionic blood flow at the area behind the maximum chorionic tissue to detect resistance index.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal placental site | – | Device: Transvaginal ultrasoundwomen with normal implantation site at early trimester with normal placental site |
| Low placental site | – | Device: Transvaginal ultrasoundwomen with low implantation site at early trimester with low placental site |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women at their early trimester with or without cesarean section scar
Key inclusion criteria (2 listed)
- Single intrauterine pregnancy
- Gestational age less than 10 weeks
Key exclusion criteria (3 listed)
- Any condition distorting uterine cavity as myoma, uterine anomalies.
- Absent fetal pulsations
- Any condition needing termination of early pregnancy as molar pregnancy or severe deteriorating maternal disease
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 |
|---|---|---|
| Transvaginal ultrasoundtransvaginal ultrasound done before 10 weeks gestational age measuring the distance between the lower end of the hyperechoic trophoblast ring of the gestational sac and the inner cervical os | Device | Low placental site, normal placental site |
Primary outcome
Distance between the implantation site and the internal cervical os
Time frame: 10 weeks to 40 weeks gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: Undecided
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.
Ahmed Maged, 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 Placenta Implantation Site, 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Maged, MD (0020201005227404, dr_ahmedmaged@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between the implantation site and the internal cervical os (time frame: 10 weeks to 40 weeks gestational age). 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 7 Mar 2018.