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IRCT20181218042033N5 IRCT 2022-07-15 Vice-Chancellery for Research Hormozgan University of Medical Sciences Betadine versus metronidazole gel for post-cesarean section infections Vaginal preparation with povidone-iodine versus metronidazole for preventing post-Cesarean infections 2021-11-22 anticipated 426 Complete https://irct.ir/trial/62534 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 Post-cesarean section infection. Intervention 1: Control group: Abdominal skin preparation using 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran) and then draping using sterile surgical drapes before cesarean section. Intervention 2: Intervention group 1: 10 min to 2 hours prior to cesarean section, the whole vagina as well as the anterior and posterior fornices will be washed in a 360-degree rotational manner for 30 seconds, using two pieces of sterile gauze soaked in 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran). Then abdominal skin preparation will be done using 7.5% povidone-iodine and draping using sterile surgical drapes before cesarean section. Intervention 3: Intervention group 2: 2 hours prior to cesarean section, 5 g metronidazole gel 0.75% (Pars Darou, Iran) will be used for vaginal preparation. Then abdominal skin preparation will be done using 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran) and draping using sterile surgical drapes before cesarean section. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Nazanin Abdi
Dr. Ali Shariati Hospital, Shahid Naser Blvd., Next to the Revolutionary Court, Bandar Abbas, Hormozgan
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 5934 abdinazanain834@gmail.com Bandare-abbas University of Medical Sciences scientific Nazanin Abdi
Dr. Ali Shariati Hospital, Shahid Naser Blvd., Next to the Revolutionary Court, Bandar Abbas, Hormozgan
Bandar Abbas Iran (Islamic Republic of) 7916613885 +98 76 3333 5934 abdinazanin834@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Elective cesarean section Singleton pregnancy no limit no limit Female Severe bleeding Hypersensitivity to metronidazole or povidone-iodine Active genital herpes Severe anemia (hematocrit <30%) Human immunodeficiency virus (HIV) infection Body mass index (BMI) >30 kg/m2 Preeclampsia Diabetes mellitus Antibiotic or corticosteroid use Rupture of membranes Chorioamnionitis Fever due to any cause prior to cesarean section (temperature >38 C) O86.12 Endometritis following delivery Prevention Prevention Prevention Control group: Abdominal skin preparation using 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran) and then draping using sterile surgical drapes before cesarean section Intervention group 1: 10 min to 2 hours prior to cesarean section, the whole vagina as well as the anterior and posterior fornices will be washed in a 360-degree rotational manner for 30 seconds, using two pieces of sterile gauze soaked in 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran). Then abdominal skin preparation will be done using 7.5% povidone-iodine and draping using sterile surgical drapes before cesarean section. Intervention group 2: 2 hours prior to cesarean section, 5 g metronidazole gel 0.75% (Pars Darou, Iran) will be used for vaginal preparation. Then abdominal skin preparation will be done using 7.5% povidone-iodine (Iran Najo Co., Tehran, Iran) and draping using sterile surgical drapes before cesarean section. Endometritis. Timepoint: Up to 15 days after cesarean section. Method of measurement: Clinical examination. Wound infection. Timepoint: Up to 15 days after cesarean section. Method of measurement: Clinical examination. Vice-Chancellery for Research Hormozgan University of Medical Sciences Approved 2021-03-10 Ethics Committee of Hormozgan University of Medical Sciences Hormozgan University of Medical Sciences, Chamran Blvd., Bandar Abbas, Iran Bandar Abbas Hormozgan Iran (Islamic Republic of)