A multicentre randomised controlled trial comparing elective and selective caesarean section for the delivery of the preterm breech infant. The Iowa premature breech trial. The delivery route for very-low-birth-weight infants. A preliminary report of a randomized, prospective study. A failed RCT to determine the best method of delivery for very low birth weight infants. Collaborative study on preterm breeches: vaginal delivery versus caesarean section.
To determine the optimum mode of delivery for women in preterm breech labour at a gestational age of 26 to 32 weeks.
                A multicentre randomised controlled trial.
                Twenty-six hospitals in England, UK.
                Women with a singleton breech fetus in spontaneous preterm labour between 26 and 32 completed weeks of gestation, with no clear indication for a caesarean section or vaginal breech delivery.
                Random allocation to either "intention to delivery vaginally' or "intention to deliver by caesarean section'.
                Perinatal mortality, neonatal morbidity, maternal morbidity and gestation at delivery.
                The trial was closed after 17 months because of low recruitment, by which time substantial numbers of women had been in the eligible gestation period. Thirteen women from six hospitals were recruited. One infant, randomised to and delivered vaginally, was stillborn. Three fetal presentations were cephalic at delivery despite a diagnosis of breech presentation at trial entry. No formal statistical analysis was performed due to the small numbers.
                No conclusions about the optimum mode of delivery for women in preterm labour with a fetus presenting by the breech can be drawn from this trial. The low accrual rate was due to clinicians' reluctance to randomise eligible women, reflecting the circumstances and nature of the trial. A prospective, randomized clinical trial involving patients in premature labor (28 to 36 weeks' gestation) with breech presentation comparing 18 with immediate cesarean section with 20 with observed labor was undertaken at the University of Iowa from 1978 to 1983. The "observed labor" group had more deaths and lower Apgar scores (not statistically significant). Acidosis at delivery was not more common in the observed labor group, but 25% were delivered by cesarean section for fetal distress. The only neonatal deaths of nonanomalous babies, who were acidotic at delivery, occurred in patients who were managed outside of the trial, because delivery occurred soon after admission to the hospital. Congenital malformations accounted for one-third of the neonatal deaths; birth trauma did not occur in the 38 study patients. A major problem facing the perinatal team remains the care of the very-low-birth-weight infant (less than 1,500 gm), which includes not only the neonatal aspects but also the specific management aspects of labor and delivery. Numerous retrospective studies have suggested the potential benefits of cesarean delivery in the very-low-birth-weight group. In order to specifically address the question of the delivery route and its impact on neonatal outcome, a randomized, prospective study was designed. The study design specifically attempted to exclude the usual clinical estimation of fetal weight and sought to rely on other factors, which included the clinical availability of ultrasound as utilized by the physician staff. As the study proceeded, it became apparent on numerous occasions that the birth weights of infants who had been entered into this study were, in fact, in excess of the targeted weight range of 750-1,500 gm. In one instance an infant weighed in excess of 3,000 gm, and these observations led to a temporary discontinuation of the study. Data evaluation was undertaken from the first 40 patients entered into the study. This limited comparison failed to demonstrate significant differences regarding measures chosen to evaluate neonatal condition. It did define the limitations of correctly choosing infants for inclusion in this study. It is clear that more precise selection criteria must be available before the study of the effects of delivery route on outcome can be resumed appropriately. An RCT to determine the optimum method of delivery for very low birth weight (VLBW) infants was canceled after it had been in progress for only 5 months when it was discovered that more than 40% of eligible patients were being withdrawn from the trial before randomization. A review of hospital births before the trial began suggested that the trial was held too late: that a critical shift in obstetric practice towards abdominal delivery of VLBW infants had already occurred. Obtaining patient consent to participation, which had been the main predicted problem, was not difficult. nan
There is not enough evidence to evaluate the use of a policy of planned immediate caesarean delivery for preterm babies. Further studies are needed in this area, but recruitment is proving difficult.