Postpartum Infectious Morbidity in Cesarean Section DeliveryNCT03007706
Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery
An observational study of Postpartum Infectious Morbidity in Cesarean Section Delivery, run by Raghda Gamal Mohamed.
Trial summary
This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity and to assess potential maternal adverse effects and any impact on the infant. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Infectious Morbidity in Cesarean Section Delivery
- What is being tested?
- Women undergo cesarean section delivery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- How long will I take part?
- 2 Weeks
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women undergo cesarean section delivery whether elective or emergency
Who may be able to join
- Women undergoing cesarean delivery, both elective and non-elective.
- Rupture of membranes and labor contractions will be allowed.
Who cannot join
- Unknown outcome from the patient.
- Refusing to participate in the study from the admission conse
- Allergy to antibiotics.
- Any visible infection.
About this study
This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity and to assess potential maternal adverse effects and any impact on the infant.
- Being tested
- Women undergo cesarean section delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women undergo cesarean section deliveryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity
Measured: 2 weeks following cesarean section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Infectious Morbidity in Cesarean Section DeliveryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Raghda Gamal Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raghda Gamal Mohamed, Minia Maternity University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007706
- Sponsor's protocol ID
- MiniaMUH
- Status last verified
- Dec 2016
- First submitted
- 29 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery
- ClinicalTrials.gov ID
- NCT03007706
- Acronym / sponsor ID
- MiniaMUH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Raghda Gamal MohamedUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 2 Jan 2017 (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.
This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity and to assess potential maternal adverse effects and any impact on the infant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women undergo cesarean section delivery whether elective or emergency
Key inclusion criteria (2 listed)
- Women undergoing cesarean delivery, both elective and non-elective.
- Rupture of membranes and labor contractions will be allowed.
Key exclusion criteria (4 listed)
- Unknown outcome from the patient.
- Refusing to participate in the study from the admission conse
- Allergy to antibiotics.
- Any visible infection.
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 |
|---|---|---|
| Women undergo cesarean section delivery | Procedure or surgery | – |
Primary outcome
role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity
Time frame: 2 weeks following cesarean section
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Infectious Morbidity in Cesarean Section Delivery, run by Raghda Gamal Mohamed.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. 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?
Results are not available in the source record.
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?
role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity (time frame: 2 weeks following cesarean section). 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 4 Jan 2017.