Povidone Iodine Versus Normal Saline in Preoperative Vaginal Cleansing Before Caesarean Section

NCT ID: NCT06950229

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2021-03-09

Brief Summary

Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and preoperative vaginal cleansing with povidone-iodine use in reduction of post-caesarean endometritis.Povidone iodine has been found to cause significant irritation to the vaginal mucosa especially in females with iodine hypersensitivity necessitating the study of efficacy of normal saline which has minimal side effects in the prevention of post caesarean complications

Detailed Description

BACKGROUND: Maternal infectious morbidity is a common complication of caesarean section and is the third leading cause of maternal mortality in Nigeria and account for 15% of maternal death worldwide. Post-caesarean maternal infectious morbidity is still a big challenge despite prophylactic antibiotics and other modalities adopted to prevent it. Recently, preoperative vaginal cleansing with povidone-iodine (PI) was recommended in reduction of post-caesarean endometritis, but this may lead to significant irritation to the vaginal mucosa resulting from allergic reactions in females with iodine hypersensitivity. Normal saline (NS) is an effective cleaning solution and doesn't have allergic effect on healthy tissues. It is accessible, non-irritant, and less expensive in contrast to povidone iodine.

AIM: To compare the difference in the incidence of postoperative vaginal irritation symptoms and the rate of postoperative infections after using Povidone iodine versus Normal saline solution in vaginal cleansing before caesarean section at the Alex Ekwueme Federal University Teaching Hospital Abakaliki.

METHODOLOGY: This was a randomized controlled trial involving two hundred and twenty four (224) consenting pregnant women undergoing caesarean section in AE-FUTHA. These women were grouped into two arms; group 1 (Vaginal cleansing with povidone iodine) and group 2 (vaginal cleansing with normal saline solution). Both groups received prophylactic antibiotics and anterior abdominal wall scrubbing. Subsequently, the researcher and assistant reviewed the patients for infectious

morbidity daily during ward rounds till discharge and vaginal irritation symptoms 24hours postoperatively, and daily during ward round till discharge.

DATA ANALYSIS: Data was analyzed using statistical Package for Social Science (IBM SPSS) software (version 20, Chicago II, USA). Continuous variables were presented as mean and standard deviation (Mean ± SD), while categorical variables were presented as numbers, frequencies and percentages. Student t- test (t-test) was used for comparison between groups for quantitative variables while the chi- square was performed for comparing categorical variables. Relative risk and 95% confidence interval were calculated for outcome measures. A difference with a P value of < 0.05 was taken to be statistically significant.

Conditions

Povidone Iodine; Normal Saline; Pre-operative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Povidone group

Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.

Group Type: ACTIVE_COMPARATOR

Povidone-Iodine

Intervention Type: DRUG

Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.

Normal Saline

Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.

Group Type: EXPERIMENTAL

Normal Saline

Intervention Type: DRUG

Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal Saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500 mg of metronidazole was given prior to the procedure.

Interventions

Povidone-Iodine

Hundred (100) ml of 5% povidone iodine was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of 5% povidone iodine and was allowed to be well soaked with 5% povidone iodine and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500mg of metronidazole was given prior to the procedure.

Intervention Type: DRUG

Normal Saline

Hundred (100) ml of Normal saline was poured into a sterilized bowl (galipot). Three pieces of gauze held with sponge holding forceps was dipped into the sterilized bowl containing 100mls of Normal Saline and was allowed to be well soaked with Normal saline and thereafter used to swab the vulva in 360 degrees. one gram of ceftriaxone and 500 mg of metronidazole was given prior to the procedure.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

. All consenting parturient for either elective or emergency caesarean section after the age of viability

Exclusion Criteria

• Women with known allergy to topical povidone-iodine.
• Women with presence of pre-existing vaginal irritation symptoms as itching, burning, swelling and vaginal pain.
• Antepartum haemorrhage (Placenta praevia).
• Cord prolapse
• Clinical evidence of Chorioamnionitis
• Face presentation with ruptured membranes to avoid contact of fetal face with iodine.
• Women with immunosupression due to HIV/AIDS, Diabetes Miletus or chronic use of steroids.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

AE-FUTHA/REC/VOL3/2020/069

Identifier Type: -

Identifier Source: org_study_id