Placenta PreviaNCT03772184
Modified Cervical Inversion During CS in Placenta Previa
A study testing Cervical inversion in people with Placenta Previa, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
There is an increasing rates of placenta previa nowadays Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Cervical inversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2019to 15 May 2019
- Phase
- Interventional
- 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 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant women 38 weeks or more with placenta previa
Who cannot join
- pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alalfy Modofied Cervical Inversion During CS in Placenta Previa
There is an increasing rates of placenta previa nowadays
Read the detailed description
several techniques were described to control bleeding .
- Conditions
- Placenta Previa
- Being tested
- Cervical inversion
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical inversionProcedure or surgery
inverting the cervical lip after delivery
| Study group | Role | What they receive |
|---|---|---|
| cervical inversion | Active comparator | Not described Receives: Procedure: Cervical inversion |
| no cervical inversion | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
how can the cervical inversion technique controls the placental bed bleeding
Measured: within an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start10 Jan 2019
- Primary completion12 May 2019
- Study completion15 May 2019
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using cervical inversion during cesarean section
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suez Canal University
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, National research centre , Aljazeerah hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772184
- Sponsor's protocol ID
- Modified cervical inversion
- Status last verified
- Feb 2022
- First submitted
- 10 Dec 2018
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alalfy Modofied Cervical Inversion During CS in Placenta Previa
- ClinicalTrials.gov ID
- NCT03772184
- Acronym / sponsor ID
- Modified cervical inversion
- Conditions
- Placenta Previa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Suez Canal University
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 11 Dec 2018 (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.
There is an increasing rates of placenta previa nowadays
Detailed description
several techniques were described to control bleeding .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Using cervical inversion during cesarean section
| Arm | Type | Receives |
|---|---|---|
| cervical inversion | Active comparator | Procedure: Cervical inversion |
| no cervical inversion | No intervention | – |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant women 38 weeks or more with placenta previa
Key exclusion criteria (1 listed)
- pregnant ladies with normally implanted placenta or placenta accreat , increta or percreta
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 |
|---|---|---|
| Cervical inversioninverting the cervical lip after delivery | Procedure or surgery | cervical inversion |
Primary outcome
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion
Time frame: within an hour
how can the cervical inversion technique controls the placental bed bleeding
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 22 Feb 2022.
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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.
Mahmoud Alalfy, PhD principal investigator
National research centre , Aljazeerah hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical inversion in people with Placenta Previa, run by Aljazeera Hospital 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 1 inclusion and 1 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 22 Feb 2022. 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?
The number of women whose placental bed bleeding will be controlled by cervical inversion cervical inversion (time frame: within an hour). 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 22 Feb 2022.