Outpatient cervical ripening: Has its time come?

July 17, 2015

Two doctors from the same health system argue the opposite sides of this issue.

My Opinion: Outpatient cervical ripening should be offered to select women

Lauren D Demosthenes, MD

Dr Demosthenes is Assistant Clinical Professor, Department of Obstetrics and Gynecology, Greenville Health System, South Carolina.

Ann is a 25-year-old who presents at 41 weeks’ gestation for her routine and uncomplicated prenatal visit. On exam, her cervix is closed and soft. Her Bishop score is 5. You offer her cervical ripening and induction of labor and she agrees to this plan. In fact, her best friend in another state just went through the same thing last month. She tells you that the woman went home after her cervical ripening and returned for induction the next morning. Ann would really like this option, as she is much more comfortable at home.

Approximately 25% of women in the United States undergo induction of labor.1 In women with an unfavorable cervix, usually defined as a Bishop score of ≤6, cervical ripening is used to facilitate the process of cervical softening, thinning, and dilation. This leads to a shorter induction-to-delivery time and a lower probability of a failed induction. Cervical ripening can be accomplished either pharmacologically or mechanically. Pharmacologic agents include synthetic prostaglandin E1 (PGE1) and E2 (PGE2). Risks include tachysystole with possible fetal heart rate concerns. Mechanical dilation most often is performed with a Foley catheter or other balloon catheter, which is inserted through the unfavorable cervix. Risks include a very low likelihood of postpartum fever and post-insertion bleeding.

In an era of patient-centered care, providing safe, high-quality, cost-conscious options for patients has never been more important. It is our responsibility as caregivers to offer reasonable choices that have the potential to enhance the patient experience. Evidence shows that outpatient cervical ripening is appropriate in selected patients. Indeed, the American College of Obstetricians and Gynecologists states in its Practice Bulletin on induction of labor that outpatient cervical ripening, particularly mechanical methods, may be appropriate in carefully selected patients.1

A randomized, double-blind placebo-controlled study published in 2009 looked at outpatient oral misoprostol for prolonged pregnancies and found that patients receiving misoprostol had a significantly shorter time interval from study entry to onset of spontaneous labor and to delivery when compared with the placebo group. Although there were no significant differences in maternal or fetal morbidity, the study was not powered to determine safety in the outpatient setting. So we found out that pharmacologic ripening works but could not conclude that it is safe.2

In comparing mechanical to pharmacologic cervical ripening, use of a Foley and pharmacologic cervical ripening have demonstrated similar efficacy.3,4 For outpatient versus inpatient cervical ripening, a Foley catheter also has been shown to be equally effective in both settings, with a high satisfaction rate in women in the outpatient arm of the study. In addition, outpatient management resulted in a reduction in length of hospital stay, which is beneficial for both patient and hospital.5

But what about safety? A more recent retrospective cohort study published in 2014 built upon this work to provide more information about the safety of outpatient management. Over 3 ½ years, 1905 patients met criteria for outpatient cervical ripening. Patients were monitored for 2 hours after Foley bulb placement then allowed to go home and return at 0600 the following morning. No adverse obstetric events were reported to the use of the Foley catheter in the cervical ripening phase. The authors concluded that utilization of a Foley catheter for cervical ripening is an ideal outpatient option.6

In light of these data regarding length of hospital stay, patient satisfaction, safety, and potential cost savings in the outpatient setting, we should consider offering this option to our carefully selected patients.

“So yes, Ann, you can go home to your own bed the night before your induction.”

NEXT: We're not there quite yet ... >>

References

1. ACOG Committee on Practice Bulletins—Obstetrics. Induction of Labor: ACOG Practice Bulletin No. 107. Obstet Gynecol. 2009;114(2 Pt 1):386–397.

2. Gaffaney C, Saul L, Rumney P, Morrison E, Thomas S, Nageotte M, Wing D. Outpatient oral misoprostol for prolonged pregnancy: a pilot investigation. Am J Perinatol. 2009;26:673–678.

3. Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006;49(3):642–657.

4. Vaknin Z, Kurzweil Y, Sherman D. Foley catheter balloon vs locally applied prostaglandins for cervical ripening and labor inductions: a systematic review and metaanalysis. Am J Obstet Gynecol. 2010;203(5):418–429.

5. Sciscione AC, Muench M, Pollack M, Jenkins TM, Tidlon-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.

6. Sciscione AC, Bedder C, Hoffman MK, Ruhstaller K, Sholssman PA. The timing of adverse events with Foley catheter preinduction cervical ripening: implications for outpatient use. Am J Perinatol. 2014;31:781–786.

 

My Opinion: Outpatient cervical ripening for select patients may be on the horizon, but we're not there yet.

 

Kacey Eichelberger, MD

Dr Eichelberger is Assistant Professor, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of South Carolina Greenville School of Medicine/Greenville Health System.

 

Ann’s question is certainly a reasonable one, and echoes with refrains familiar to most delivery providers. As she approaches the birth of her child, she draws upon the positive experience of a trusted friend who underwent outpatient cervical ripening and presumably had a positive birth experience. Those of us privileged enough to deliver babies encounter such personal requests day in and day out: “I was thinking I may want to deliver in the tub . . . what do you think?” “Will you wait to cut the cord until it stops pulsing?” “I’d like to give birth at home . . . is that okay?”

Part of our job as women’s healthcare providers is to help patients navigate the vast and often murky waters between personal narrative, traditional practice patterns, and, for lack of a better word, scientific evidence. Two basic questions serve as a helpful starting point when considering requests that veer away from our otherwise “normative” practice patterns: Does it work? and Is it safe?

From a purely biologic standpoint, most would presume that cervical ripening should be equally as effective in the outpatient and inpatient settings. However, there is always a chance that unmeasured variables affect the performance of an intervention in one environment over another. To this end, Sciscione and colleagues conducted a randomized controlled trial (RCT) of preinduction cervical ripening with a Foley catheter, in which 61 women were randomized to outpatient ripening and 50 to traditional inpatient.1 The primary outcome of the study—mean change in Bishop score—was no different between the 2 study groups. That is to say, Foley catheter ripening worked as well in an outpatient setting as it did in an inpatient one. In 2014, Wilkinson and colleagues published the results of their large RCT, in which 827 women were randomized to outpatient versus inpatient cervical ripening with PGE2.2 There was no significant difference between the 2 study groups in the primary outcome, total oxytocin use, or cesarean section rate.

Now the question, is it safe? In the Wilkinson trial mentioned above, 47% of women randomized to the outpatient PGE2 arm did not ultimately receive the intervention, and of those 215 women who did have the prostaglandin placed, 47 (21.8%) remained inpatient for abnormal fetal heart rate (FHR) tracing, labor, or personal request. Indeed, only 103 of 411 women (25%) randomized to the outpatient arm ultimately received the intervention and remained at home through the designated ripening period. This is consistent with existing data on inpatient ripening with prostaglandins, which carries with it the known risk of tachysystole and FHR abnormalities. The safety data are stronger for outpatient mechanical ripening: Sciscione reviewed the records of more than 1900 women who underwent inpatient pre-induction ripening with Foley catheters, and identified no adverse outcomes among that cohort.3

Finally, what do the authorities say? The American College of Obstetricians and Gynecologists hedges, saying that outpatient ripening by mechanical means may be appropriate for select patients.4 The Cochrane Review, too, is inconclusive, noting that the data are limited, and “it is not yet possible to determine whether induction of labour is effective and safe in outpatient settings.”5 Finally, our own hospital system, with almost 7000 deliveries annually, has not yet agreed that evidence is sufficient to change practice recommendations.

Ultimately, Ann, the data on safety and feasibility of outpatient cervical ripening with prostaglandins are not convincing, and I would not recommend their use outside the research setting. While I believe the data on safety and feasibility of mechanical dilation are very promising, that practice falls outside our current practice guidelines.

"So, Ann, what can we do to make your inpatient ripening experience as comfortable for you as possible?

References

1. Sciscione AC, Muench M, Pollack M, Jenkins TM, Tidlon-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.

2. Wilkinson C, Bryce R, Adelson P, Turnbull D. A randomised controlled trial of outpatient compared with inpatient cervical ripening with prostaglandin E₂ (OPRA study). BJOG. 2015;122(1):94–104.

3. Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014;31(9):781–786.

4. ACOG Committee on Practice Bulletins—Obstetrics. Induction of Labor: ACOG Practice Bulletin No. 107. Obstet Gynecol. 2009;114(2 Pt 1):386–397.

5. Kelly AJ, Alfirevic Z, Ghosh A. Outpatient versus inpatient induction of labour for improving birth outcomes. Cochrane Database Syst Rev. 2013;11:CD007372.