Transverse position. Using rotation to aid normal birth-OUTcomes following manual rotation (the TURN-OUT trial): a randomized controlled trial.

ABSTRACT

BACKGROUND: The fetal occiput transverse position in the second stage of labor is associated with adverse maternal and perinatal outcomes. Prophylactic manual rotation in the second stage of labor is considered a safe and easy to perform procedure that has been used to prevent operative deliveries. OBJECTIVE: This study aimed to determine the efficacy of prophylactic manual rotation in the management of the occiput transverse position for preventing operative delivery. We hypothesized that among women who are at ≥37 weeks' gestation with a baby in the occiput transverse position early in the second stage of labor, manual rotation compared with a "sham" rotation will reduce the rate of operative delivery. STUDY DESIGN: A double-blinded, parallel, superiority, multicenter, randomized controlled clinical trial in 3 tertiary hospitals was conducted in Australia. The primary outcome was operative (cesarean, forceps, or vacuum) delivery. Secondary outcomes were cesarean delivery, serious maternal morbidity and mortality, and serious perinatal morbidity and mortality. Outcomes were analyzed by intention to treat. Proportions were compared using χ2 tests adjusted for stratification variables using the Mantel-Haenszel method or Fisher exact test. Planned subgroup analyses by operator experience and technique of manual rotation (digital or whole hand rotation) were performed. The planned sample size was 416 participants (trial registration ACTRN12613000005752). RESULTS: Here, 160 women with a term pregnancy and a baby in the occiput transverse position in the second stage of labor, confirmed by ultrasound, were randomly assigned to receive either a prophylactic manual rotation (n=80) or a sham procedure (n=80), which was less than our original intended sample size. Operative delivery occurred in 41 of 80 women (51%) assigned to prophylactic manual rotation and 40 of 80 women (50%) assigned to a sham rotation (common risk difference, -4.2% [favors sham rotation]; 95% confidence interval, -21 to 13; P=.63). Among more experienced proceduralists, operative delivery occurred in 24 of 47 women (51%) assigned to manual rotation and 29 of 46 women (63%) assigned to a sham rotation (common risk difference, 11%; 95% confidence interval, -11 to 33; P=.33). Cesarean delivery occurred in 6 of 80 women (7.5%) in the manual rotation group and 7 of 80 women (8.7%) in the sham group. Instrumental (forceps or vacuum) delivery occurred in 35 of 80 women (44%) in the manual rotation group and 33 of 80 women (41%) in the sham group. There was no significant difference in the combined maternal and perinatal outcomes. The trial was terminated early because of limited resources. CONCLUSION: Planned prophylactic manual rotation did not result in fewer operative deliveries. More research is needed in the use of manual rotation from the occiput transverse position for preventing operative deliveries.