Abstract
Background
Leveraging the safety profile of the synthetic hygroscopic cervical dilator (SHCD), one potential way to reduce the burden-of-care provision in the labor-and-delivery unit without compromising safety is to introduce a low-acuity care room (ripening room) for patients undergoing cervical ripening as a part of labor induction at term.
Methods
Implementing a ripening room using SHCDs was compared to scenarios using prostaglandins including a dinoprostone insert (PGE2 insert) or gel (PGE2 gel) and misoprostol given orally (oral PGE1) or vaginally (vaginal PGE1). A theoretical, cost-consequence model was developed to assess costs, staff time, and selected clinical outcomes related to cervical ripening. The model assessed a hypothetical cohort where patients remained in hospital from admission for induction of labor (IOL) to delivery, taking the US labor-and-delivery unit perspective. Model inputs were taken from structured searches of PubMed and ClinicalTrials.gov, published US guidance, and clinical practice. Results are presented as mean (95% credible interval [CrI]).
Results
The ripening room using SHCDs cost US$3,210 and required 10.22 hours (h) of nurse time on average per patient. The cost difference to prostaglandins ranged from −$894 (−$2,269 to $398) for PGE2 gel to +$460 (−$1,467 to $1,539) for vaginal PGE1. Mean nurse time was shorter than all prostaglandins, with time savings ranging from −7.05 (−24.55 to 5.73) h for PGE2 insert to −0.97 (−14.69 to 9.59) h for vaginal PGE1. When outcomes of the probabilistic sensitivity analysis were ranked from 1 (best) to 5 (worst), the ripening room using SHCDs ranked 1.94 for costs and 1.97 for nurse time. In a nulliparous population, results improved for the ripening room using SHCDs relative to all prostaglandins.
Conclusion
In this theoretical study, implementing a ripening room using SHCDs resulted in the lowest time burden and the second lowest costs. The cheapest option for preinduction cervical ripening was vaginal misoprostol.
PLAIN LANGUAGE SUMMARY
It is estimated that approximately 20% of deliveries in the USA are submitted to cervical ripening prior to induction of labor to facilitate a vaginal delivery. Cervical ripening can be achieved either by administering a synthetic hormone, called a prostaglandin (e.g. misoprostol or dinoprostone), or by using mechanical means of stretching the cervix (e.g. using the synthetic hygroscopic cervical dilator – SHCD). Prostaglandins have been associated with an increased risk of overstimulating uterus contractions such that the person undergoing cervical ripening with prostaglandins requires close monitoring. Each method for cervical ripening has advantages and disadvantages and there is no high-quality evidence to recommend one from the others based on clinical outcomes. In this theoretical study, we estimated the hospital costs and staff time for induction of labor care when using the SHCD in a lower acuity setting within the hospital, without monitoring facilities, in comparison to the patient remaining in the labor-and-delivery room using misoprotol or dinoprostone preparations. Our results suggest that misoprostol resulted in the least expensive option closely followed by the SHCD in a lower acuity setting, both with the potential for notable cost savings when compared to using dinoprostone preparations for cervical ripening. In addition, we associated up to several hours less staff time with the use of the SHCD in a lower acuity setting in comparison to misoprostol and dinoprostone. Patients that were delivering for the first time benefitted more from using the SHCD in a lower acuity setting in comparison to those who had delivered previously.
Transparency
Declaration of funding
This work was funded by Medicem Inc., the US distributor/importer of Dilapan-S.
Declaration of financial/other interests
SJS and RTT are employees and RS is the owner of Coreva Scientific GmbH & Co KG, which received consultancy fees for performing, analyzing, and communicating the work presented here. TW is an employee of Medicem Inc, which paid the consultancy fees to Coreva Scientific GmbH & Co KG. JLG and BE were paid scientific consultants for Medicem Inc.
Author contributions
Conceptualization, SJS, TW, and RS; methodology and data collection, SJS, JLG, TW, RS, and BE; software, SJS.; validation, RTT and RS; writing – manuscript preparation, SJS; writing – review and editing, RTT, TW, JLG, RS, and BE; visualization, SJS; supervision, RS; project administration, SJS. All authors have read and agreed to the published version of the manuscript.
Acknowledgements
The authors acknowledge Claudia Gersten, CNM MS FNP, for her insights into US-specific obstetrics and IOL practice, and on the current literature landscape.
Reviewer disclosures
Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.