Decrease Maternal MorbidityNCT02943148
Prediction of Pelvic Adhesions at Repeat Cesarean Delivery
An observational study of Decrease Maternal Morbidity, run by Assiut University at 1 site in Egypt.
Trial summary
Several methods have been used to predict adhesions after abdominal operations. High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were the methods that were evaluated in the English literature for this study. 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?
- Davey score for striae gravidarum
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Jun 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: All Women who will be admitted to our Labor Ward for emergency or elective cesarean section will be invited to participate.
Who may be able to join
- Women with at least previous one cesarean
- Full term (37- 41 weeks)
- Women accepted to participate in the study
Who cannot join
- History of pelvic inflammatory disease
- History of endometriosis
- Previous pelvic surgery other than cesarean
- History of wound site infections
- History of long corticosteroid use
- Women with midline incisions
- Women with placenta accreta
- Women refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of Striae Gravidarum Severity and Cesarean Scar Characteristics for Pelvic Adhesions at Repeat Cesarean Delivery
Several methods have been used to predict adhesions after abdominal operations. High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were the methods that were evaluated in the English literature for this study. Estimating the likelihood of adhesions and related complications after prior surgery and assessing the severity of adhesion formation after surgery is not easy. Anticipating adhesions is very important to preventing complications by ensuring that the necessary preoperative preparations are in place and/or that appropriate cases are referred to a tertiary center.
- Conditions
- Decrease Maternal Morbidity
- Being tested
- Davey score for striae gravidarum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Davey score for striae gravidarumOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of of abdominal adhesions in relation to striae scoring system
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 startNov 2016
- Primary completionMar 2018
- Study completionJun 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 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
- NCT02943148
- Sponsor's protocol ID
- PACS
- Status last verified
- May 2020
- First submitted
- 21 Oct 2016
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Striae Gravidarum Severity and Cesarean Scar Characteristics for Pelvic Adhesions at Repeat Cesarean Delivery
- ClinicalTrials.gov ID
- NCT02943148
- Acronym / sponsor ID
- PACS
- Conditions
- Decrease Maternal Morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jun 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.
Several methods have been used to predict adhesions after abdominal operations. High-resolution ultrasonography, magnetic resonance imaging and scar healing properties were the methods that were evaluated in the English literature for this study. Estimating the likelihood of adhesions and related complications after prior surgery and assessing the severity of adhesion formation after surgery is not easy. Anticipating adhesions is very important to preventing complications by ensuring that the necessary preoperative preparations are in place and/or that appropriate cases are referred to a tertiary center.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Women who will be admitted to our Labor Ward for emergency or elective cesarean section will be invited to participate.
Key inclusion criteria (3 listed)
- Women with at least previous one cesarean
- Full term (37- 41 weeks)
- Women accepted to participate in the study
Key exclusion criteria (8 listed)
- History of pelvic inflammatory disease
- History of endometriosis
- Previous pelvic surgery other than cesarean
- History of wound site infections
- History of long corticosteroid use
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 |
|---|---|---|
| Davey score for striae gravidarum | Other | – |
Primary outcome
Rate of of abdominal adhesions in relation to striae scoring system
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 13 May 2020.
- Individual participant dataSharing planned: Yes
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 3 inclusion and 8 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 13 May 2020. 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?
Rate of of abdominal adhesions in relation to striae scoring system (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 13 May 2020.