EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY

NCT ID: NCT07053995

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Endometrial Infection Surgical Site Infection Following Cesarean Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Participants with vaginal cleaning

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.

Group Type EXPERIMENTAL

Vaginal cleaning

Intervention Type PROCEDURE

Before giving incision for C-section surgery, vaginal cleaning was done with 50cc diluted antiseptic solution as a single push.

Participants with non vaginal cleansing

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.

Group Type OTHER

Non vaginal cleansing

Intervention Type OTHER

Routine abdominal scrubbing was carried out before incision. No vaginal cleaning was done before incision.

Interventions

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Vaginal cleaning

Before giving incision for C-section surgery, vaginal cleaning was done with 50cc diluted antiseptic solution as a single push.

Intervention Type PROCEDURE

Non vaginal cleansing

Routine abdominal scrubbing was carried out before incision. No vaginal cleaning was done before incision.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women between 18-40 years
* Gestational age greater than 36 weeks undergoing elective C section

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Khyber Teaching Hospital

OTHER

Sponsor Role lead

Responsible Party

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Naba Rehman

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Hira Hassan, MBBS FCPS

Role: STUDY_DIRECTOR

Khyber Teaching Hospital Peshawar

Locations

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Khyber Teaching Hospital Peshawar Pakistan

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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978

Identifier Type: -

Identifier Source: org_study_id

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