EndometrialNCT07053995
EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY
A study testing Vaginal cleaning and Non vaginal cleansing in people with Endometrial and Infection, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial, Infection, Surgical Site Infection Following Cesarean Delivery
- What is being tested?
- Vaginal cleaning and Non vaginal cleansing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2021to 31 Jul 2021
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women between 18-40 years
- Gestational age greater than 36 weeks undergoing elective C section
Who cannot join
- Pregnant women with history of allergic reactions to chlorhexidine
- Placenta previa on ultrasound scan
- Diabetes Mellitus on fasting blood sugar
- Anemia (Hb less than 7g/dl)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Teaching Hospital Peshawar Pakistan
Peshawar, Khyber Pakhtunkhwa, 23301
About this study
After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14.
Read the detailed description
After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution as single push where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14. Data was recorded and analyzed.
- Being tested
- Vaginal cleaning, Non vaginal cleansing
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal cleaningProcedure or surgery
Before giving incision for C-section surgery, vaginal cleaning was done with 50cc diluted antiseptic solution as a single push.
Non vaginal cleansingOther
Routine abdominal scrubbing was carried out before incision. No vaginal cleaning was done before incision.
| Study group | Role | What they receive |
|---|---|---|
| Participants with vaginal cleaning | Experimental | Total of 38 participants included randomly after informed consent. Vaginal cleaning with 50cc (0.5cc chlorhexidine) along with abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded. Receives: Procedure: Vaginal cleaning |
| Participants with non vaginal cleansing | Other | Total of 38 participants included randomly after informed consent. Only routine abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded. Receives: Other: Non vaginal cleansing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial Infection
Body temperature was measured postoperatively along with any dicharge of pain around uterine region 24hrs after surgery
Measured: 14 days
Surgical site infection
Incision site was inspected on 4th and 14th post operative day and documented any evidence of infection signs according to Southampton wound grading system.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Feb 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometrialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naba Rehman, Khyber Teaching Hospital
- Investigators
- Dr Hira Hassan, MBBS FCPS, Study director, Khyber Teaching Hospital Peshawar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053995
- Sponsor's protocol ID
- 978
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY
- ClinicalTrials.gov ID
- NCT07053995
- Acronym / sponsor ID
- 978
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 8 Jul 2025 (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.
After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14.
Detailed description
After obtaining an informed consent a detailed history and clinical examination was performed. Labs were carried out to fulfill inclusion and exclusion criteria. Women were randomly divided into two groups. In Intervention group vaginal cleaning was done with 50cc diluted antiseptic solution as single push where as control group had abdominal scrub only. Participants were followed and incision site was checked at day 14. Data was recorded and analyzed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with vaginal cleaning | Experimental | Procedure: Vaginal cleaningTotal of 38 participants included randomly after informed consent. Vaginal cleaning with 50cc (0.5cc chlorhexidine) along with abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded. |
| Participants with non vaginal cleansing | Other | Other: Non vaginal cleansingTotal of 38 participants included randomly after informed consent. Only routine abdominal scrubbing was done before giving incision for C-section. Prophylactic antibiotics were given. Participants were followed and incision site was inspected on day 14. Data was recorded. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women between 18-40 years
- Gestational age greater than 36 weeks undergoing elective C section
Key exclusion criteria (4 listed)
- Pregnant women with history of allergic reactions to chlorhexidine
- Placenta previa on ultrasound scan
- Diabetes Mellitus on fasting blood sugar
- Anemia (Hb less than 7g/dl)
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 |
|---|---|---|
| Vaginal cleaningBefore giving incision for C-section surgery, vaginal cleaning was done with 50cc diluted antiseptic solution as a single push. | Procedure or surgery | Participants with vaginal cleaning |
| Non vaginal cleansingRoutine abdominal scrubbing was carried out before incision. No vaginal cleaning was done before incision. | Other | Participants with non vaginal cleansing |
Primary outcome
Endometrial Infection
Time frame: 14 days
Body temperature was measured postoperatively along with any dicharge of pain around uterine region 24hrs after surgery
Surgical site infection
Time frame: 14 days
Incision site was inspected on 4th and 14th post operative day and documented any evidence of infection signs according to Southampton wound grading system.
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 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Dr Hira Hassan, MBBS FCPS study director
Khyber Teaching Hospital Peshawar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal cleaning and Non vaginal cleansing in people with Endometrial and Infection, run by Khyber Teaching Hospital at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 8 Jul 2025. 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 Pakistan. 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?
Endometrial Infection (time frame: 14 days). The study lists 2 primary outcomes in all. 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 8 Jul 2025.