Prospective randomized controlled trial comparing inpatient and outpatient Foley catheter cervical ripening

Abstract

Background To evaluate the safety of Foley catheter cervical ripening and patients’ satisfaction in outpatient versus inpatient setting. Methods Sixty low risk women were randomized to outpatient (n = 25) and inpatient (n = 35) cervical ripening using Foley catheter. In both groups Foley catheter with 60 ml balloon was digitally inserted through the cervix with gentle traction applied. The outpatient group was discharged home after provision of verbal and written 24-hours contact information and instructions. The inpatient group was admitted to the ward. They were reassessed the next morning unless labor had begun or the catheter had dropped off. Results The demographic data between the two groups did not differ. The outpatient group has significant improvement in the Bishop score at second assessment (9.04 versus 7.89, p = 0.04), reduced duration of inpatient stay (41 versus 59, p < 0.001), able to sleep 5–6 hours (9 versus 1, p = 0.001), able to rest (23 versus 16, p = 0.001) and relax (23 versus 10, p < 0.001). Significantly, more women in the inpatient group had wished to be in the outpatient group (3 versus 21, p < 0.001). There was no difference in initial Bishop score, duration of oxytocin infusion and delivery within 24 hours. Both groups were similar in caesarean section rate, total blood loss, maternal and neonatal infection, primary postpartum hemorrhage, neonatal birthweight and cord pH. There was no incidence of uterine hyperstimulation, meconium aspiration syndrome and neonatal intensive care unit admission. Conclusion Outpatient Foley catheter cervical ripening had comparable efficacy and safety with inpatient for low-risk pregnancies and associated with better patient satisfaction. Trial registration: NCT04342741. It was retrospectively registered with ClinicalTrial.gov

Outpatient Cervical Ripening with Balloon Catheters

“…Regarding the primary outcome, duration of time in the labor and delivery unit, there was a significant difference, with the outpatient group spending 16.369.7 hours in the labor and delivery unit compared with the inpatient group spending 23.8614.0 hours (mean difference 27.24 hours, 95% CI 211.03 to 23.34). When excluding the two unpublished studies (Chen V, Sheehan P. Aust N Zeal J Obstet Gynaecol 2019;59:39-40. doi: 10.1111/ajo.13067), 15 the mean difference in time in the labor and delivery unit remained significantly different (27.02 hours, 95% CI 211.19 to 22.85, n5544). The primary outcome of time in the labor and delivery unit also remained significantly different when only analyzing those studies of low risk of bias (mean difference 27.06 hours, 95% CI 212.30 to 21.30, n5496).…”

“…9,11,14 In six RCTs, no additional agents were used for cervical ripening while the balloon was in place for either arm (Chen V, Sheehan P. Aust N Zeal J Obstet Gynaecol 2019;59:39-40. doi: 10.1111/ajo.13067). 9,11,14,15 Three RCTs allowed for use of prostaglandins after the balloon in either group, typically if amniotomy was unacceptable or for a Bishop score less than 6 (Chen V, Sheehan P. Aust N Zeal J Obstet Gynaecol 2019;59:39-40. doi: 10.1111/ ajo.13067). 10,11 In two RCTs, those in the inpatient arm received oxytocin concurrently with the balloon.…”

“…Based on this, we could expect findings that compared outpatient balloon to inpatient balloon plus misoprostol to be similar to our findings, but more research, in the form of RCTs, is needed. Study protocols also differed in their use of Ausbeck 2020 13 Haavisto 2020 14 Rahman 2020 15 Foley or Cook catheters, and the inflation volumes. All studies but one 14 followed intention-to-treat analysis.…”

“…Rahman 2020, 15 Malaysia Singleton, vertex presentation, more than 37 wk of gestation, older than 18 y, intact membranes, Bishop score less than 6, lives less than 10 km or less than 30 min from hospital with transportation IUFD, FGR, EFW more than 4,000 g, anomalies, abnormal NST, unstable lie, multiple pregnancy, sepsis, hypertension, latex allergy, uterine scar, history of antepartum hemorrhage, parity more than 6, suspected cephalopelvic disproportion, placenta previa of the studies. If any differences were identified, they were discussed and a consensus reached.…”

“…*Studies excluded from meta-analysis of primary outcome due to nonreporting on this outcome. 14,15 These studies were included in meta-analysis of secondary outcomes. 13 United States Singleton, vertex presentation, 39 0/7-41 6/7 wk of gestation, nulliparous, 18 y or older, reliable transportation, telephone access, lives within 30 min of the hospital, modified Bishop score less than 5, cervical dilation 2 cm or less immediately before randomization IUFD, major anomalies, FGR, suspected macrosomia, oligohydramnios, polyhydramnios, nonreassuring fetal status (BPP result 6/10 or less), prior uterine surgery involving the myometrium, gestational hypertension or preeclampsia, uncontrolled pregestational diabetes mellitus, hepatitis B or C or HIV, latex allergy Haavisto 2020, 14 Finland Singleton, vertex presentation, 37 0/7-41 5/7 wk of gestation, uncomplicated pregnancy, intact membranes, Bishop score less than 6, normal CTG, lives within 30 min from hospital, sufficient knowledge of the Finnish language Medical conditions or pregnancy complications (ie, medically treated gestational diabetes, hypertension, preeclampsia, FGR, fetal distress)…”