Decrease Maternal MorbidityNCT02943421
Transverse B-Lynch in Management of Placenta Accreta
An observational study of Decrease Maternal Morbidity, run by Assiut University at 1 site in Egypt.
Trial summary
Placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. Life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Decrease Maternal Morbidity
- What is being tested?
- Transverse B-Lynch suture
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2016to 5 May 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: the study encompassing women managed by conservative transverse B-Lynch during cesarean section due to placenta accreta
Who may be able to join
- 1. All pregnant women with placenta previa as diagnosed by ultrasound with suspicion of abnormal placentation by Doppler us, confirmed intraoperatively undergoing either emergent or elective cesarean
Who cannot join
- Patients who will be managed by hysterectomy
- Patients who will be managed by conservative leaving the placenta in-situ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Transverse B-Lynch in Management of Placenta Accreta
Placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. Life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which leads to significant postoperative morbidity and death.
- Conditions
- Decrease Maternal Morbidity
- Being tested
- Transverse B-Lynch suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse B-Lynch sutureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated intraoperative blood loss
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion3 Feb 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decrease Maternal MorbidityStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943421
- Sponsor's protocol ID
- MAP
- Status last verified
- Jun 2018
- First submitted
- 21 Oct 2016
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Transverse B-Lynch in Management of Placenta Accreta
- ClinicalTrials.gov ID
- NCT02943421
- Acronym / sponsor ID
- MAP
- Conditions
- Decrease Maternal Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 3 Feb 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 24 Oct 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.
Placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. Life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is reported to be 3000-5500 mL, which leads to significant postoperative morbidity and death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- the study encompassing women managed by conservative transverse B-Lynch during cesarean section due to placenta accreta
Key inclusion criteria (1 listed)
- 1. All pregnant women with placenta previa as diagnosed by ultrasound with suspicion of abnormal placentation by Doppler us, confirmed intraoperatively undergoing either emergent or elective cesarean
Key exclusion criteria (2 listed)
- Patients who will be managed by hysterectomy
- Patients who will be managed by conservative leaving the placenta in-situ
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 |
|---|---|---|
| Transverse B-Lynch suture | Procedure or surgery | – |
Primary outcome
Estimated intraoperative blood loss
Time frame: 30 min
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 27 Jun 2018.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Decrease Maternal Morbidity, run by Assiut 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 1 inclusion and 2 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 27 Jun 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?
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?
Estimated intraoperative blood loss (time frame: 30 min). 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 27 Jun 2018.