To evaluate indications for exclusion in women who participated in outpatient cervical ripening studies (Outpatient Foley For Starting Induction at Term I and II). These data will assist in evaluating which parts of the scientific protocol are informative and should be retained in clinical application. This is a secondary analysis of women evaluated for enrollment in, but eventually excluded from, two randomized trials evaluating outpatient cervical ripening in low-risk parous (OFFSITE-I) and nulliparous (OFFSITE-II) women. Participants were considered low risk if they had no medical problems (other than well-controlled diabetes or hypertension), singleton pregnancies, and were 39-42 weeks gestation. Women identified as eligible at the time of pre-enrollment screening underwent an enrollment visit that included blood pressure (to rule out hypertensive disorders), ultrasound (to assess presentation, fluid, and growth), antenatal testing (to rule out non-reassuring fetal status), and a cervical exam (to determine need for ripening). In this analysis, we evaluate indications for exclusion based on the findings at the enrollment visit. Baseline maternal and pregnancy characteristics were balanced between groups. Among 354 women who presented for an enrollment visit, 98 were excluded from the trials at the study visit and included in this analysis. Of these, the majority (n=60, 17% of all women evaluated) were excluded for ultrasound findings. In this group, 49 women (14% of all women evaluated) were excluded due to a diagnosis of fetal growth restriction (regardless of antenatal testing), and 11 (3.1% of all women evaluated) were found to have polyhydramnios. (Fig 1). As we consider implementing outpatient cervical ripening into clinical practice, appropriate identification of low-risk patients is crucial. A third trimester ultrasound prior to outpatient cervical ripening identifies findings that may influence plans for outpatient cervical ripening and should be performed as part of clinical protocols.
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