EFFECTIVENESS OF PREOPERATIVE VAGINAL CLEANING IN REDUCING POST CAESAREAN INFECTIOUS MORBIDITY

NCT07053995 | Completed

• 1 other identifier: 978
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometrial; Infection; Surgical Site Infection Following Cesarean Delivery

Outcome Measures

Primary Outcomes (2)

• Endometrial Infection

  Body temperature was measured postoperatively along with any dicharge of pain around uterine region 24hrs after surgery

  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.

  14 days

Study Arms (2)

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.

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.

Other: Non vaginal cleansing

Interventions

Vaginal cleaning PROCEDURE

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

Participants with vaginal cleaning

Non vaginal cleansing OTHER

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

Participants with non vaginal cleansing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital Peshawar Pakistan

Peshawar, Khyber Pakhtunkhwa, 23301, Pakistan

Location

MeSH Terms

Conditions

Infections

Study Officials

• Dr Hira Hassan, MBBS FCPS

  Khyber Teaching Hospital Peshawar

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 8, 2025
• Study Start: February 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)