Maternal MortalityNCT02878226
Outcomes of Uterine Rupture
An observational study of Maternal Mortality, run by Assiut University at 1 site in Egypt.
Trial summary
Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Maternal Mortality
- What is being tested?
- repair of rupture
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to 18 Feb 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: All patients presented with clinical symptoms and signs of rupture uterus, whatever the duration of pregnancy, and the diagnosis proved on surgical exploration to be a case of rupture uterus
Who may be able to join
- women with ruptured uterus
- accept to share in the study
Who cannot join
- women refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterine Rupture: Prevalence and Feto-maternal Outcomes in Assiut Women Health Hospital
Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour
- Conditions
- Maternal Mortality
- Being tested
- repair of rupture
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repair of ruptureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
number of women undergoes repair
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion15 Dec 2017
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal MortalityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 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
- NCT02878226
- Sponsor's protocol ID
- UR
- Status last verified
- Jun 2018
- First submitted
- 22 Aug 2016
- Last updated
- 27 Jun 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Rupture: Prevalence and Feto-maternal Outcomes in Assiut Women Health Hospital
- ClinicalTrials.gov ID
- NCT02878226
- Acronym / sponsor ID
- UR
- Conditions
- Maternal Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 25 Aug 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.
Uterine rupture (UR) is a serious, life-threatening obstetric complication. UR is associated with an increased risk of maternal and perinatal morbidity and mortality, particularly in developing countries compared to developed countries. UR occurs mainly as a consequence of poorly managed labour
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients presented with clinical symptoms and signs of rupture uterus, whatever the duration of pregnancy, and the diagnosis proved on surgical exploration to be a case of rupture uterus
Key inclusion criteria (2 listed)
- women with ruptured uterus
- accept to share in the study
Key exclusion criteria (1 listed)
- women refuse to participate
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 |
|---|---|---|
| repair of rupture | Procedure or surgery | – |
Primary outcome
number of women undergoes repair
Time frame: 1 hour
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: Undecided
Related trials for Maternal Mortality
Enrolling by invitation
Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
Active, not recruiting
The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Maternal Morbidity and Mortality, Health Disparities
Recruiting
Scaling up Maternal Health Equity Best Practices
Maternal Mortality Disparities, Maternal Morbidity Disparities
Recruiting
The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity
Severe Maternal Morbidity, Maternal Death
Recruiting
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
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 Maternal Mortality, 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 2 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 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?
number of women undergoes repair (time frame: 1 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 27 Jun 2018.