Premature Rupture of MembraneNCT03491826
Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)
An observational study of Premature Rupture of Membrane, run by sarah mohamed hassan at 1 site in Egypt.
Trial summary
The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks. Read more about this study
- Who is it for?
- Ages 24 to 39 years, women only
- Conditions the study is for
- Premature Rupture of Membrane
- What is being tested?
- rupture of membrane
- How many people
- 1,011 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Dec 2014
- 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 24 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant female with history of rupture membrane
Who may be able to join
- rupture of membrane
Who cannot join
- medical disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM) at AIN Shams Maternity Hospital: A Retrospective Analysis of Last Five Years Admissions
The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.
Read the detailed description
The data will be retrieved from the archival files and analyzed
- Conditions
- Premature Rupture of Membrane
- Being tested
- rupture of membrane
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rupture of membraneBiological
| Study group | Role | What they receive |
|---|---|---|
| ROM before 34 weeks (A) | premature rupture of membrane before 34 weeks Receives: Biological: rupture of membrane | |
| ROM after 34 weeks (B) | premature rupture of membrane after 34 weeks Receives: Biological: rupture of membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal mortality
maternal mortality
Measured: up to 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembraneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- sarah mohamed hassan
- Sponsor type
- University, hospital or other
- Collaborators
- Hend Mostafa Hussein Salem
- Responsible party
- Sponsor-investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491826
- Sponsor's protocol ID
- 123
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM) at AIN Shams Maternity Hospital: A Retrospective Analysis of Last Five Years Admissions
- ClinicalTrials.gov ID
- NCT03491826
- Acronym / sponsor ID
- 123
- Conditions
- Premature Rupture of Membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- sarah mohamed hassanUniversity, hospital or other
- Collaborators
- Hend Mostafa Hussein Salem
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 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.
The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.
Detailed description
The data will be retrieved from the archival files and analyzed
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROM before 34 weeks (A) | – | Biological: rupture of membranepremature rupture of membrane before 34 weeks |
| ROM after 34 weeks (B) | – | Biological: rupture of membranepremature rupture of membrane after 34 weeks |
Who may qualify
- Ages
- 24 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant female with history of rupture membrane
Key inclusion criteria (1 listed)
- rupture of membrane
Key exclusion criteria (1 listed)
- medical disorder
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 |
|---|---|---|
| rupture of membrane | Biological | ROM after 34 weeks (B), ROM before 34 weeks (A) |
Primary outcome
maternal mortality
Time frame: up to 48 hours after delivery
maternal mortality
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 9 Apr 2018.
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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.
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 Premature Rupture of Membrane, run by sarah mohamed hassan 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 9 Apr 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?
maternal mortality (time frame: up to 48 hours after delivery). 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 9 Apr 2018.