Premature Rupture of Fetal MembranesNCT06735703
Group B Streptococcus Infection and PROM Incidince
An observational study of Premature Rupture of Fetal Membranes and Group B Streptococcal Infection, run by Assiut University.
Trial summary
To investigate incidince of prom with GBS infection and role of prophylaxis against it Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Rupture of Fetal Membranes, Group B Streptococcal Infection
- What is being tested?
- To provide ampicillin sulbactam to pregnant women with premature rupture of membrane
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 25 Dec 2024to 9 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pregnant women with prom
Who may be able to join
- Pregnant women with prom after 34 wks festation
Who cannot join
- Bleeding disorder
- emergency conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sherif Abdelmeged badran contact
About this study
Official title: Incidince of PROM with GBS Infection and Prophylaxis Against It
To investigate incidince of prom with GBS infection and role of prophylaxis against it
- Being tested
- To provide ampicillin sulbactam to pregnant women with premature rupture of membrane
- Medical subject headings
- Fetal Membranes, Premature Rupture, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To provide ampicillin sulbactam to pregnant women with premature rupture of membraneDrug
To provide ampicillin sulbactam tonpregnant women with premature rupture of membrane after 34 wks gestation
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women after 34 wks with PROM | Not described Receives: Drug: To provide ampicillin sulbactam to pregnant women with premature rupture of membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidince of prom with GBS infection and prophylaxis against it
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of Fetal MembranesStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Kamel, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735703
- Sponsor's protocol ID
- GBS WITH PROM
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidince of PROM with GBS Infection and Prophylaxis Against It
- ClinicalTrials.gov ID
- NCT06735703
- Acronym / sponsor ID
- GBS WITH PROM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Jan 2026 (estimated)
- First posted
- 16 Dec 2024 (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.
To investigate incidince of prom with GBS infection and role of prophylaxis against it
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women after 34 wks with PROM | – | Drug: To provide ampicillin sulbactam to pregnant women with premature rupture of membrane |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with prom
Key inclusion criteria (1 listed)
- Pregnant women with prom after 34 wks festation
Key exclusion criteria (2 listed)
- Bleeding disorder
- emergency conditions
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 |
|---|---|---|
| To provide ampicillin sulbactam to pregnant women with premature rupture of membraneTo provide ampicillin sulbactam tonpregnant women with premature rupture of membrane after 34 wks gestation | Drug | Pregnant women after 34 wks with PROM |
Primary outcome
Incidince of prom with GBS infection and prophylaxis against it
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
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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.
Sherif Abdelmeged badran contact
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Rupture of Fetal Membranes and Group B Streptococcal Infection, run by Assiut University.
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: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Mohamed Kamel (0927923623, dinakamel802@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidince of prom with GBS infection and prophylaxis against it (time frame: Baseline). 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 16 Dec 2024.