Takeaways
- Approximately one-third of all deliveries in the United States are the result of an induction of labor. Most patients undergoing labor induction require cervical ripening, and current inpatient practices can overburden busy labor and delivery units.
- In carefully selected patients, outpatient mechanical cervical ripening with a Foley catheter may be appropriate.
- Data show that outpatient cervical ripening with a Foley catheter is safe and can significantly decrease the overall length of hospital stay.
- In-office placement of transcervical Foley catheters is generally well tolerated by patients.
- After outpatient Foley placement, patients should return for their scheduled induction time the following day, or sooner if clinically indicated.
Labor induction is a common obstetric practice in the United States, occurring in 31.9% of deliveries in 2022.1 Elective induction rates have continued to rise since the publication of the results of the ARRIVE trial (NCT01990612) in 2018, which demonstrated a reduction in cesarean delivery and hypertensive disorders of pregnancy for low-risk nulliparous patients undergoing induction at 39 weeks.2,3
At the time of presentation for induction, approximately 84% of patients have an unfavorable cervix and require initial cervical ripening.4 However, current inpatient interventions that facilitate cervical preparation can lead to time and financial strains on already busy labor and delivery units.5 Efforts are thus aimed at reducing operational burdens, with a recent focus on outpatient cervical ripening.
The American College of Obstetricians and Gynecologists states that mechanical methods of outpatient labor induction may be an appropriate option in selected patient populations.6 Although a formal recommendation was not made, recent findings suggest this is a safe and effective alternative to inpatient practices. Cervical ripening balloons apply direct pressure to the internal cervical os, causing endogenous prostaglandin release. A bladder catheter (Foley) or a commercial intracervical balloon (eg, Cook Cervical Ripening Balloon) can be used with similar efficacy, although the Foley catheter is often more readily available and considered more cost-effective.7 This article will review the efficacy, safety, patient eligibility criteria, and procedural logistics of the Foley catheter for outpatient preinduction cervical ripening.
Efficacy of the outpatient Foley catheter
Studies have explored the use of Foley catheters for cervical ripening in an outpatient setting for some time. Data from a randomized controlled trial of 111 patients at term found that outpatient Foley use decreased hospitalization by an average of 9.6 hours compared with traditional inpatient use.8 In a more recent randomized study of 126 nulliparous patients undergoing elective induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery by 4.3 hours on average. The authors found no differences in rates of cesarean delivery or intra-amniotic infection between groups.9
A retrospective study of patients undergoing Foley catheter inductions found that in addition to shorter hospital stays, the outpatient group also incurred lower hospitalization costs, averaging $408 less than their inpatient counterparts and further supporting the outpatient Foley catheter as a cost-effective induction method.10
Similarly, a randomized trial of term multiparous patients with unfavorable cervices (Bishop score 5) was performed to investigate outcomes of Foley catheter use in parous patients. Duration of hospital stay and time from membrane rupture to delivery were shorter for the outpatient Foley induction group. Maternal satisfaction rates were similarly high for both inpatient and outpatient groups.11
Safety of outpatient mechanical cervical ripening
The safety of Foley catheters has been well established for inpatient cervical ripening. Compared with pharmacologic methods, mechanical induction with the insertion of a balloon catheter is associated with lower rates of uterine hyperstimulation and associated fetal heart rate changes.12,13 Large meta-analyses and systematic reviews of the literature have demonstrated similar risks of perinatal adverse outcomes among low-risk pregnant patients undergoing induction with a Foley catheter in the outpatient vs inpatient setting.14,15 Similarly, a Cochrane review found no significant differences between rates of uterine hyperstimulation or neonatal morbidity and mortality when comparing home and inpatient induction with a Foley catheter.16
A key difference between outpatient and inpatient induction is the inability to continuously monitor patients at home while the Foley catheter remains in situ. While findings support that outpatient preinduction cervical ripening is an overall safe intervention for appropriately screened low-risk pregnant patients, the practice is still relatively novel and both providers and patients alike may be apprehensive regarding the potential risks. A systematic review of 26 studies and 8292 patients aimed to tackle this knowledge gap—what are the risks between the time of Foley catheter inflation to expulsion? Reported adverse events occurred at rates less than 1% and included pain, unintentional amniotomy, vaginal bleeding, nonreassuring fetal heart rate, and abnormal uterine activity (Table17). There were no reports of intra-amniotic infection, placental abruption, uterine rupture, or maternal or fetal mortality. Some adverse events resulted in premature catheter removal or cesarean delivery, but in most cases, outpatient cervical ripening with the Foley catheter continued normally.17 While the procedure is overall safe, providers should be aware of potential risks to better inform patients and manage their expectations.
Patient eligibility and exclusion criteria
In review of the literature, outpatient cervical ripening with a Foley catheter may be a safe and effective option for a carefully selected cohort of pregnant patients.18,19 Standard indications for outpatient cervical ripening include term, singleton pregnancies with a fetus in cephalic presentation undergoing induction of labor (Box). Patients should be medically stable and demonstrate an understanding of the provided instructions.
In contrast, contraindications to outpatient Foley catheter use include prior cesarean delivery or other uterine surgeries involving the full thickness of the myometrium. Other exclusions include abnormalities of placental location and implantation and any conditions warranting continuous fetal monitoring, such as fetal growth restriction.
Steps for outpatient Foley catheter placement
The steps for outpatient Foley catheter placement are summarized in Figure 1. Procedural logistics for preinduction cervical ripening begin with patient counseling and obtaining informed consent. Proper patient education should include a discussion of expectations, such as cramping and light spotting, and indications to return to the hospital prior to the scheduled induction time. Standard eligibility and exclusion criteria should be reviewed to determine the patient’s candidacy for the procedure. Next, the provider should confirm cephalic presentation and normal amniotic fluid via sonogram.
The equipment required for outpatient mechanical cervical ripening include the following: (1) 14 to 26 French Foley catheter with 30-mL balloon, (2) sterile water or saline, (3) 30-mL syringe, (4) speculum (optional), (5) ring forceps (optional), and (6) tape (optional). After placing the patient in lithotomy position, the provider should perform a baseline cervical examination to determine the need for cervical ripening. The provider then guides the Foley catheter through the cervix either digitally or using a speculum and ring forceps. If using the speculum technique, it may be helpful to mark the approximate length of the cervix on the catheter to assist with placing the Foley just proximal to the internal cervical os. Once in place, the balloon is inflated to 30 mL. The excess catheter tubing can either be tied off and tucked into the vaginal canal or be taped to the patient’s thigh (Figure 2).
Following the procedure, a nonstress test may be performed to confirm fetal well-being and ensure a lack of uterine hyperstimulation. If deemed stable, the patient is discharged with instructions to return the following day for their scheduled induction of labor. Indications to present to care sooner include rupture of membranes, persistent vaginal bleeding, severe pain, decreased fetal movement, and fever. The Foley catheter can be deflated and removed if not already expelled when a patient presents for their induction.
Cervical ripening with a Foley catheter is generally well tolerated by patients.11 Mild cramping is expected and can be managed with standard outpatient labor comfort measures. Individual institutions are encouraged to create personalized protocols to meet their specific needs and may opt to partner with inpatient triage providers for catheter placement.
Conclusion
In conclusion, outpatient cervical ripening with a Foley catheter may be a safe and effective option for low-risk pregnant patients. Available data show that preinduction mechanical ripening with a Foley leads to shorter length of hospital stay, helping to improve efficiency and reduce costs for labor and delivery units. In addition to less time spent inpatient, data show the procedure is overall safe and well tolerated. In an era of high labor induction rates, obstetric providers may see a shift toward standardized implementation of outpatient Foley catheter inductions across practices.
References
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- Grobman WA, Rice MM, Reddy UM, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network. Labor induction versus expectant management in low-risk nulliparous women. N Engl J Med. 2018;379(6):513-523. doi:10.1056/NEJMoa1800566
- Nethery E, Levy B, McLean K, Sitcov K, Souter VL. Effects of the ARRIVE (A Randomized Trial of Induction Versus Expectant Management) trial on elective induction and obstetric outcomes in term nulliparous patients. Obstet Gynecol. 2023;142(2):242-250. doi:10.1097/AOG.0000000000005217
- Bernardes TP, Broekhuijsen K, Koopmans CM, et al. Caesarean section rates and adverse neonatal outcomes after induction of labour versus expectant management in women with an unripe cervix: a secondary analysis of the HYPITAT and DIGITAT trials. BJOG. 2016;123(9):1501-1508. doi:10.1111/1471-0528.14028
- Grobman WA, Sandoval G, Reddy UM, et al; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Health resource utilization of labor induction versus expectant management. Am J Obstet Gynecol. 2020;222(4):369.e1-369.e11. doi:10.1016/j.ajog.2020.01.002
- ACOG Practice Bulletin No. 107: induction of labor. Obstet Gynecol. 2009;114(2 pt 1):386-397. doi:10.1097/AOG.0b013e3181b48ef5
- Liu X, Wang Y, Zhang F, et al. Double- versus single-balloon catheters for labour induction and cervical ripening: a meta-analysis. BMC Pregnancy Childbirth. 2019;19(1):358. Published 2019 Oct 16. doi:10.1186/s12884-019-2491-4
- Sciscione AC, Muench M, Pollock M, Jenkins TM, Tildon-Burton J, Colmorgen GH. Transcervical Foley catheter for preinduction cervical ripening in an outpatient versus inpatient setting. Obstet Gynecol. 2001;98(5 pt 1):751-756. doi:10.1016/s0029-7844(01)01579-4
- Ausbeck EB, Jauk VC, Xue Y, et al. Outpatient Foley catheter for induction of labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2020;136(3):597-606. doi:10.1097/AOG.0000000000004041
- Washburn MC, Washburn M, Hong C, Roth P, Richter P. Outpatient Foley catheter induction protocol provides clinical and cost benefits. Birth. 2021;48(4):574-582. doi:10.1111/birt.12568
- Hamdan M, Shuhaina S, Hong JGS, et al. Outpatient vs inpatient Foley catheter induction of labor in multiparas with unripe cervixes: a randomized trial. Acta Obstet Gynecol Scand. 2021;100(11):1977-1985. doi:10.1111/aogs.14247
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- de Vaan MD, Ten Eikelder ML, Jozwiak M, et al. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023;3(3):CD001233. Published 2023 Mar 30. doi:10.1002/14651858.CD001233.pub4
- Zhao G, Song G, Liu J. Outpatient cervical ripening with balloon catheters: a Bayesian network meta-analysis of randomized controlled trials. Int J Gynaecol Obstet. 2024;166(2):607-616. doi:10.1002/ijgo.15409
- McDonagh M, Skelly AC, Hermesch A, et al. Cervical Ripening in the Outpatient Setting: Comparative Effectiveness Review No. 238. Agency for Healthcare Research and Quality; 2021. AHRQ publication 21-EHC011.
- Alfirevic Z, Gyte GM, Nogueira Pileggi V, Plachcinski R, Osoti AO, Finucane EM. Home versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2020;8(8):CD007372. Published 2020 Aug 27. doi:10.1002/14651858.CD007372.pub4
- Diederen M, Gommers J, Wilkinson C, Turnbull D, Mol B. Safety of the balloon catheter for cervical ripening in outpatient care: complications during the period from insertion to expulsion of a balloon catheter in the process of labour induction: a systematic review. BJOG. 2018;125(9):1086-1095. doi:10.1111/1471-0528.15047
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