Vaginal preparation with povidone-iodine versus metronidazole for preventing post-Cesarean infections

Comparison of vaginal preparation with metronidazole gel and povidone-iodine for the prevention of post-cesarean section infections

Phase-III single-blind randomized controlled trial with 3 parallel groups on 426 patients, randomization with sealed envelopes

This study will include pregnant women referred to Shariati Hospital, Bandar Abbas, Iran scheduled for elective cesarean section (CS). Participants will be randomized into 3 groups. The control group will only be prepped (using 7.5% povidone-iodine) and draped. The first intervention group will receive vaginal preparation with metronidazole and the third intervention group 7.5% povidone-iodine in addition to prepping and draping. Patients will be followed up to 15 days after CS. Evaluations will be done by another researcher who is blinded to the grouping of the patients.

Inclusion criteria: Elective cesarean section, Singleton pregnancy Exclusion criteria: Severe bleeding, Hypersensitivity to povidone-iodine or metronidazole, Active genital herpes, Severe anemia (hematocrit <30%), Human immunodeficiency virus infection, Body mass index >30 kg/m2, Preeclampsia, Diabetes mellitus, Antibiotic or corticosteroid use, Rupture of membranes, Chorioamnionitis, Fever due to any cause before cesarean section (temperature >38 C)

Control group: Abdominal skin preparation using povidone-iodine and then draping before C-section; Intervention group 1: 10 min to 2 hours prior to C-section, the whole vagina and the anterior and posterior fornixes will be washed in a 360-degree rotational manner for 30 seconds, using povidone-iodine, then prepping and draping before cesarean section. Intervention group 2: 2 hours prior to C-section, metronidazole gel will be used for vaginal preparation, then prepping and draping before cesarean section.

Endometritis

Simple randomization with individuals as units of randomization along with allocation concealment: 426 unclear envelopes and 426 cards with the names of the groups (A, B, C) will be prepared (142 cards for each group). The cards will be put into the envelopes and the envelopes will be sealed and provided to the investigator. Upon entrance of each patient to the study, the envelopes will be shuffled and one will randomly be selected. The patient will be allocated to group A, B, or C based on the card inside the selected envelope.

The study will be single-blind, so that the investigator in charge of outcome assessing will be unaware of patient groupings. Therefore, blinding will only be done for the outcome-assessor and the patients, the healthcare providers, and the statistician will know patient groupings.

There is no further information.