Placenta PreviaNCT03208842
Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar
An observational study of Placenta Previa, run by Cairo University at 1 site in Egypt.
Trial summary
After gaining verbal consent , Patients included in this study will be subjected to: 1. history taking : peronal history . obstetric history. past history 2. general examination including vital signs 3. abominal and pelvic examination 4. the patient will be examined son graphically at 3 visits 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- trans vaginal ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2017to 30 Sep 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women with or without previous cesarean section scar are assessed at 10 weeks of gestational age then at 36 weeks to detect the relation between implantation site and placental site
Who may be able to join
- singleton intrauterine pregnancy.
- gestational age less than 10 weeks
- history of previous cesarean section(one or more)
Who cannot join
- negative fetal pole pulsation.
- any condition distorting uterine cavity i.e uterine myoma,uterine cavity anomalies
- multifetal pregnancy.
- any condition necessitate termination of early pregnancy i.e maternal medical disorder ,molar pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar With Doppler Assessment of Retro Chorionic Blood Flow
After gaining verbal consent , Patients included in this study will be subjected to:
- history taking :
Read more
- peronal history .
- obstetric history.
- past history
- general examination including vital signs
- abominal and pelvic examination
- the patient will be examined son graphically at 3 visits
- The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):
- anterior,
- posterior,
- Fundal,
- low-lying anterior,\
- low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane.
- doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
- then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery
Read the detailed description
After gaining verbal consent , Patients included in this study will be subjected to:
- history taking :
- peronal history .
- obstetric history.
- past history
- general examination including vital signs
- abominal and pelvic examination
- the patient will be examined son graphically at 3 visits
- The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):
- anterior,
- posterior,
- Fundal,
- low-lying anterior,\
- low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane. -----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
- then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery
- Conditions
- Placenta Previa
- Being tested
- trans vaginal ultrasound
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans vaginal ultrasoundRadiation
trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of
---the site of the intrauterine gestational sac in relation to the endometrial cavity
| Study group | Role | What they receive |
|---|---|---|
| women with previous cesarean scar | the patient will be examined son graphically at 3 visits
1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of
---the site of the intrauterine gestational sac in relation to the endometrial cavity .
-----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery . Receives: Radiation: trans vaginal ultrasound | |
| women without previous cesarean scar | the patient will be examined son graphically at 3 visits
1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of
---the site of the intrauterine gestational sac in relation to the endometrial cavity .
-----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery . Receives: Radiation: trans vaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placenta previa
measuring the distance between lower placental edge and internal os of the cervix by ultrasound
Measured: at 36 weeks of gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start15 Jul 2017 (estimated)
- Primary completion31 Aug 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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
- Cohort
- 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, kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208842
- Sponsor's protocol ID
- 6
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Implantation Site to Placental Site in Presence or Absence of Cesarean Section Scar With Doppler Assessment of Retro Chorionic Blood Flow
- ClinicalTrials.gov ID
- NCT03208842
- Acronym / sponsor ID
- 6
- Conditions
- Placenta Previa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 6 Jul 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.
After gaining verbal consent , Patients included in this study will be subjected to:
- history taking :
- peronal history .
- obstetric history.
- past history
- general examination including vital signs
- abominal and pelvic examination
- the patient will be examined son graphically at 3 visits
- The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):
- anterior,
- posterior,
- Fundal,
- low-lying anterior,\
- low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane.
- doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
- then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery
Detailed description
After gaining verbal consent , Patients included in this study will be subjected to:
- history taking :
- peronal history .
- obstetric history.
- past history
- general examination including vital signs
- abominal and pelvic examination
- the patient will be examined son graphically at 3 visits
- The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of---the site of the intrauterine gestational sac in relation to the endometrial cavity . For the purposes of this study and to obtain consistent findings, it was decided to have only five subgroups of gestational site implantation in relation to the endometrial cavity (Fig. 2):
- anterior,
- posterior,
- Fundal,
- low-lying anterior,\
- low lying posterior We adopted the definition of implantation site from previous publication (Abdallah et al., 2012). The implantation site is visualized in the sagittal plane as a hyperechoic ring that occupies one side of the implanted gestational sac and protrudes into the endometrial lumen It represents the maternal decidual reaction and the beginning of maternal-fetal circulation. This area is also believed to be responsible for future placental formation and development (Brosens and Gellersen, 2010) Distance between the implantation site and the internal cervical ostium (os). This was taken from the lower end of the hyperechoic trophoblast ring of the gestational sac to the internal cervical os in the sagittal plane. -----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed.
- then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with previous cesarean scar | – | Radiation: trans vaginal ultrasoundthe patient will be examined son graphically at 3 visits 1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of ---the site of the intrauterine gestational sac in relation to the endometrial cavity . -----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed. 2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery . |
| women without previous cesarean scar | – | Radiation: trans vaginal ultrasoundthe patient will be examined son graphically at 3 visits 1. The first visit at less than 10 weeks gestation :trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of ---the site of the intrauterine gestational sac in relation to the endometrial cavity . -----doppler assessment of the retro chorionic blood flow in the area behind the maximum chorionic tissue to detect sensitivity index (RI),in cases of low gestational sac Doppler assessment of peri trophoplastic blood flow will be assessed. 2. then the patient will be enrolled during routine ANC till delivery and data collected at32-34 weeks gestation regarding placental site will be correlated with 1st data and data at delivery . |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women with or without previous cesarean section scar are assessed at 10 weeks of gestational age then at 36 weeks to detect the relation between implantation site and placental site
Key inclusion criteria (3 listed)
- singleton intrauterine pregnancy.
- gestational age less than 10 weeks
- history of previous cesarean section(one or more)
Key exclusion criteria (4 listed)
- negative fetal pole pulsation.
- any condition distorting uterine cavity i.e uterine myoma,uterine cavity anomalies
- multifetal pregnancy.
- any condition necessitate termination of early pregnancy i.e maternal medical disorder ,molar pregnancy.
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 |
|---|---|---|
| trans vaginal ultrasoundtrans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of ---the site of the intrauterine gestational sac in relation to the endometrial cavity | Radiation | women with previous cesarean scar, women without previous cesarean scar |
Primary outcome
Placenta previa
Time frame: at 36 weeks of gestational age
measuring the distance between lower placental edge and internal os of the cervix by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Maged, MD principal investigator
kasr Alainy medical school
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 Previa, 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 3 inclusion and 4 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 6 Jul 2017. 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 (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Placenta previa (time frame: at 36 weeks of 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 6 Jul 2017.