Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Vaginal Antimicrobacterial Preparation Before Cesarean Secation for Endometritis Prevention
Brief Summary: The investigators designed a randomized controlled trial to evaluate whether perioperative Vaginal preparation is superior to no Vaginal preparation in decreasing post CS endometritis. Since CS is performed in about 30% of all births and infection complicates 6-11% of all CS reducing the rate of this post CS complication can have a major impact not only on the hospital occupancy and costs but also on the new mother experience and ability to face the challenge that awaits for her with her newborn.

In this study patients will be randomly assigned into two groups. The experiment group will not undergo any vaginal preparation. The control will undergo perioperative vaginal preparation with antiseptic soap followed by chlorohexidine-alcohol Both groups will be checked for cervical dilation with sterile gloves before surgery.

Primary outcome - signs of endometritis (e.g. erythema around surgical scar, discharge or pain). Patients will be followed daily until discharge. A blood count will be drewn before discharge to rule out signs of infection. Patients will be contacted 6 weeks after surgery by telephone to inquire about any signs of infection, Emergency Room visits or ambulatory visits to the doctor due to endometritis. The participants will be asked if they had positive skin culture or other wound complications such as cellulitis, seroma or scar separation.

The investigators estimated that 1040 patients will have to enroll into the study, 520 in each group in order to have 80% power to detect 50% difference in the endometritis rates between the two groups with a two tailed α level of 0.05.

The data analysis was conducted according to the per-protocol principle.


Options:
A: Arm Label: Iodine-alcohol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Iodine-alcohol | Arm Label: Chlorhexidine-alcohol; Type: EXPERIMENTAL; Interventions: Drug: Chlorhexidine-alcohol | Intervention Type: DRUG; Name: Iodine-alcohol; Assigned to Arm(s): Iodine-alcohol | Intervention Type: DRUG; Name: Chlorhexidine-alcohol; Assigned to Arm(s): Chlorhexidine-alcohol
B: Arm Label: Chlorhexidine gluconate vaginal scrub and cloth; Type: EXPERIMENTAL; Interventions: Drug: 2% chlorhexidine gluconate cloth, Drug: 4% Chlorhexidine gluconate vaginal scrub | Arm Label: Standard Treatment; Type: ACTIVE_COMPARATOR; Interventions: Drug: 2% chlorhexidine gluconate cloth | Intervention Type: DRUG; Name: 2% chlorhexidine gluconate cloth; Assigned to Arm(s): Chlorhexidine gluconate vaginal scrub and cloth, Standard Treatment | Intervention Type: DRUG; Name: 4% Chlorhexidine gluconate vaginal scrub; Assigned to Arm(s): Chlorhexidine gluconate vaginal scrub and cloth
C: Arm Label: Chlorhexidine gluconate vaginal scrub; Type: EXPERIMENTAL; Interventions: Drug: EZ scrub vaginal chlorhexidine 4% solution | Arm Label: Povidone-iodine vaginal scrub; Type: ACTIVE_COMPARATOR; Interventions: Drug: 10% provodine-iodine vaginal preparation | Intervention Type: DRUG; Name: EZ scrub vaginal chlorhexidine 4% solution; Assigned to Arm(s): Chlorhexidine gluconate vaginal scrub | Intervention Type: DRUG; Name: 10% provodine-iodine vaginal preparation; Assigned to Arm(s): Povidone-iodine vaginal scrub
D: Arm Label: Women going CS without vaginal preparation before surgery; Type: ACTIVE_COMPARATOR; Interventions: Other: No vaginal preparation before CS with Septal soap and septol. | Arm Label: Women going CS with vaginal preparation before surgery; Type: PLACEBO_COMPARATOR; Interventions: Other: vaginal preparation before CS with Septal soap and septol. | Intervention Type: OTHER; Name: vaginal preparation before CS with Septal soap and septol.; Assigned to Arm(s): Women going CS with vaginal preparation before surgery | Intervention Type: OTHER; Name: No vaginal preparation before CS with Septal soap and septol.; Assigned to Arm(s): Women going CS without vaginal preparation before surgery

Answer: D