Randomized controlled trial of the effect of 30% versus 80% fraction of inspired oxygen on cesarean delivery surgical site infection.

OBJECTIVE: To determine if supplemental perioperative oxygen will reduce surgical site infection (SSI) following cesarean delivery. METHODS: This is a randomized, controlled trial evaluating SSI following either 30% or 80% fraction of inspired oxygen (FIO2) during and 2 hours after cesarean delivery. Anesthesia providers administered FIO2 via a high-flow oxygen blender. Subjects, surgeons, and wound evaluation teams were blinded. Serial wound evaluations were performed. Data were analyzed using logistic regression models, Fisher exact test, and t test. RESULTS: In all, 179 women were randomized, and 160 subjects were included in the analysis. There were 12/83 (14.5%) SSIs in the control group versus 10/77 (13.0%) in the investigational group (p = 0.82). Caucasian race, increased body mass index, and longer operative time were identified as significant risk factors for infection (p = 0.026, odds ratio 0.283; p = 0.05, odds ratio = 1.058; p = 0.037, odds ratio = 1.038, respectively). CONCLUSION: Perioperative oxygenation with 80% Fio2 is not effective in reducing SSI following cesarean delivery.

A randomized trial of micronized progesterone for the prevention of recurrent preterm birth.

We sought to evaluate the effectiveness of daily oral micronized progesterone (MP) in preventing recurrent spontaneous preterm birth (RSPB) and whether MP increases maternal serum progesterone. We performed a pilot, single-center, randomized, double-blind, placebo-controlled trial in women with a prior preterm birth and current singleton gestation at 16 to 20 weeks ( N = 33). The primary outcome was the rate of RSPB. Subjects were given either daily MP (400 mg) or placebo from 16 to 34 weeks. Serum progesterone was obtained at enrollment and in the late second/early third trimester. Pregnancy outcome data were collected. RSPB occurred in 5/19 (26.3%) in the MP group versus 8/14 (57.1%) in placebo group ( P = 0.15). The mean age at delivery was 37.0 ± 2.7 weeks for the MP group versus 35.9 ± 2.6 weeks for the placebo ( P = 0.3). Mean serum progesterone at 28 weeks was 122.6 ± 61.8 pg/mL for MP group versus 90.1 ± 38.7 pg/mL for placebo ( P = 0.19). MP was associated with a trend toward a reduction in RSPB and an increase in the maternal serum progesterone. Although the primary outcome in this pilot study did not reach statistical significance, the results suggest a favorable trend meriting further investigation.