May Betadine Improve Cesarean Section Outcomes?

This was a single-centre randomized controlled trial performed at Department of Obstetrics and Gynecology of San Camillo Hospital of Rome. The protocol was approved by the Internal Review Board. All women having a cesarean section (CS) were eligible for recruitment unless there was suspected or known allergy to iodine. The study was widely publicized around obstetrics unit and all women were provided antenatally with a brief statement regarding the study. The study was presented to women as part of hospital initiative to reduce postoperative infections and to improve postoperative recovery. Consent was obtained from all women at the time of consenting for CS.

Background was recorded for each patient: maternal age, gestational week at delivery, BMI, and pregnancy complication; plural fetal pregnancies, premature rupture of membranes, placenta previa and pre-eclampsia. The investigators recorded the type of cesarean procedure, elective (scheduled operations) or urgent (patients in labor and maternal or fetal emergent indication), mean surgical time to perform CS.

In Literature, povidone-iodine irrigation has been demonstrated to be a simple and inexpensive solution with the potential to prevent surgical site infection , which can also reduce the incidence of intra-abdominal infectious complications when used as an intraperitoneal irrigant in patients undergoing bacterially-contaminated surgical procedures, i.e. orthopedic, general surgery, oncologic surgery. Therefore, the investigators aimed to test its use in CS.

Patients were intra-operatively randomized to receive intraperitoneal irrigation prior to abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I LMW) diluted 50:50 with normal saline or with only normal saline solution. Randomization to 'Betadine' or 'no Betadine' group was performed using sequentially numbered sealed opaque envelopes that contained the allocation. The allocation was prepared using computer generated list of random numbers using a variable block of 10 and performed by a staff members, part of the clinical team. After all layers were sutured and just prior to starting skin closure, the envelope with the allocation was opened by one of the theatre nurse.

All CS were generally performed under spinal anesthesia by the specialist obstetricians, credentialed trainee registrars or by juniors in the presence of a specialist obstetrician using the modified Misgav Ladach surgical technique.