Introduction:~This is a two-step, single center, prospective study evaluating the use of Dilapan-S for preinduction cervical ripening. Phase one of the study involves a pilot study to assess the best approach to imaging of the cervix following Dilapan-S placement. Placement of Dilapan-S will be in accordance to FDA guidelines and will be performed in the exact same manner in phase 1 and phase 2 of the study. The pilot study will be conducted on 4 patients (2: placement with gauze and 2: placement without gauze) who are scheduled for a medical or elective induction at Sentara Norfolk General's Labor and Delivery Unit. Consent for the study will be obtained on the Labor and Delivery Unit prior to the start of induction. After placement of Dilapan-S in accordance with FDA standards, the investigators plan to perform transabdominal, transvaginal, and transperineal ultrasound to determine the optimal route of cervical visualization in order to obtain individual Dilapan-S diameter measurements, in addition to, internal os cervical diameter, overall cervical length, and 3D cervical volume measurements. Safety of ultrasound examination during pregnancy has been proven for both the mother and fetus and given that the ultrasound will be limited to the cervix during measurements, no fetal ultrasound exposure is expected. The ultrasound methods that will be performed will follow the As Low As Reasonably Achievable ALARA principle set forth by the American Institute of Ultrasound in Medicine (AIUM). Preparation and cleaning of the endovaginal probes and safe handling will be observed throughout the study. Each route of ultrasound will be performed on two patients with saturated gauze (with sterile water) placement at the time of Dilapan-S placement to determine route of optimal visualization. Similarly, each route of ultrasound will be performed on two separate patients without gauze placement at the time of Dilapan-S insertion to determine the route of optimal visualization. Ultrasound evaluation will be performed at approximately 3, 6, 8 and 12 hours post Dilapan-S placement to ensure that visualization is not changed during the Dilapan-S dilation. At each time point, each ultrasound route will take approximately 5 minutes or less to complete.~Phase Two:~After completion of the pilot study, and selection of optimal method to image the cervix with Dilapan-S placement, women who are scheduled for a medical or elective induction will be screened and consented at the Eastern Virginia Medical School (EVMS) Maternal Fetal Medicine office at Hofheimer Hall. After consent is obtained, a baseline bishop score, 2D and 3D transvaginal ultrasound to assess cervical length along with transabdominal estimated fetal weight will be obtained by the primary investigator within 72 hours of the scheduled induction at Hofheimer Hall in a scheduled research-only visit. Cervical dilation will be assessed by digital exam at the time of bishop scoring. Cervical length is to be assessed according to CLEAR guidelines. An ultrasound estimated fetal weight will be performed and based on the Hadlock formula.~Women enrolled in the study will undergo induction of labor at Sentara Norfolk General Hospital. Women will be randomly allocated to 1 of 2 arms of the study. The first arm will assess the predetermined cervical measurements with placement of approximately 2 gauze that are saturated in sterile water during the initial Dilapan-S insertion. The second arm of the study will again assess the predetermined cervical measurements without placement of gauze during the initial Dilapan-S insertion. Insertion of Dilapan-S is to be performed by 4-5 trained operators and will follow an EVMS-OBGYN approved protocol. Women will complete continuous cardiotocography monitoring for 20 minutes prior to the Dilapan-S (rod size 4 x 65 mm) placement as per the manufacturer's instructions. At the time of placement, consent will again be confirmed, and contraindications reassessed. The number of rods to be placed will vary based on the patient's parity, but on average is generally 3-5 rods. Again, ultrasound evaluation will be performed at approximately 3, 6, 8 and 12 hours post Dilapan-S placement to measure the prespecified data collection points. At each time interval, each ultrasound route will take approximately 5 minutes or less to complete.~The primary objective of this study is to determine, by ultrasound, the rate of cervical dilation using DILAPAN-S for pre-induction cervical ripening. The investigators hypothesize that DILAPAN-S will achieve its maximal rate of change in cervical dilation within the first six hours of placement. A secondary aim of the study is to determine whether rates of cervical dilation differ between patients who have gauze inserted with Dilapan-S and patients who do not have gauze inserted. The investigators hypothesize that the change in dilation across time points will be greater in the DILAPAN-S with soaked-gauze group compared with the Dilapan-S only group. The third aim of the study is to assess patient satisfaction scores and determine whether satisfaction scores differ between patients who have gauze inserted with Dilapan-S and patients who do not.~Screening/recruitment/consenting:~Patients who meet criteria for inclusion in the study will be approached for participation. Women scheduled for induction of labor at Sentara Norfolk General Hospital will be approached. Written informed consent will be obtained from the patients by the primary investigator and by the study collaborators. If patients agree to participate, women undergoing medical or elective induction of labor will have their preinduction cervical ripening portion completed with DILAPAN-S in accordance with FDA labelling. Coordination, management, and data collection is to be collected by the vested authors. IRB approval is to be obtained before the study is initiated.~Results will be available to the manufacturer after statistical analysis is completed and will not be shared with the manufacturer during study execution. The manufacturer company will not be involved in data analysis and all data will be independently analyzed by EVMS Healthcare Analytics and Delivery Science Institute (HADSI). The results of this study will be presented at conferences or published in a peer-review journal.~Demographic information will be obtained from the electronic medical record. The data will be kept on a password secured EVMS computer. An encrypted USB flash drive will be used to transfer data. The data will be identified and linked to the patient using the medical record number (MRN). During data analysis, all patient identifiers will be deleted.~The PI will review the list of scheduled inductions at Sentara Norfolk General Hospital to determine if patients meet inclusion criteria. Once inclusion criteria is met, written informed consent will be obtained from the patient by the PI, study coordinator, or collaborator at the patient's next scheduled prenatal visit.The data collected will be kept on a password secured computer. An encrypted USB flash drive will be used to transfer data. The data will be linked via MRN, which is needed to access the demographic data and will be deleted when the data is analyzed.~Study visits/follow-up:~No study visits will be needed during the trial. The subject participation will be considered complete when the subject is discharged home.~Withdrawals:~Subjects who withdraw from the study after inclusion will be excluded from further follow-up. Data collected until the time of withdrawal will be analyzed~Data monitoring:~The PI, research coordinator, and collaborators will ensure that all aspects of data quality adhere to the study design. This will include monitoring for adherence to consent procedures, inclusion and exclusion criteria, valid abstraction, correct entry, timeliness and responsiveness to data queries. Data will be collected and stored with the participant ID code only. The master enrollment log linking patient identifiers with study ID numbers will be kept in a password protected database on the Ob/Gyn department's internal server. Several data collection forms will be used. Data on these forms will be devoid of personal identifiers and will be securely stored at the division offices. The research coordinator will be available to monitor the data and correct any discrepancies based on source documents if needed.~Procedures to maintain confidentiality:~Each subject will be assigned a study number with personally identifiable information deleted or removed. If needed, charts will be reviewed in the medical records area. Subjects' information will be de-identified and tagged with a number. Data will be collected and stored on a password-protected computer. Data will be collected in REDCap, or on paper form if REDCap is not available. REDCap data collection tool will be created by the PI in conjunction with EVMS HADSI and will reflect variables outlined in the study data dictionary.~Sample Size and Recruitment Goals:~The investigators plan to recruit a total of 50 participants for this study. This sample size was selected based on investigators' estimate of number of women likely to meet study inclusion criteria and choose to participate over a one-year time frame. 4 total patients will be counted in the first phase, and 40 total in the second phase with 6 patients accounting for a 12% attrition rate.~Randomization:~A total of 50 participants will be randomized for the study. Stratified block randomization with block size of 4 will be used to allocate participants on a 1:1 ratio to the two study groups (DILAPAN-S alone and DILAPAN-S with gauze). Randomization will be stratified by parity (yes/no). Randomization scheme will be generated by EVMS HADSI prior to the start of enrollment using SAS version 9.4 (SAS Institute, Cary, NC). Randomization of participants will be performed by study PI in REDCap at the time of the baseline visit after eligibility has been confirmed.~Blinding:~Due to the nature of the intervention, blinding of the participants and clinician researcher will not be possible.~Statistical Analysis Plan:~Descriptive statistics will be assessed for both study groups. Univariate analysis will be used to examine the distribution of maternal baseline variables and outcomes. Continuous baseline variables will be presented as mean (standard deviation) and categorical baseline variables will be presented as count (percent).~To assess the rate of dilation across study time points, mean change (± SD) in cervical dilation and 95% confidence intervals will be calculated and plotted for each group. Cervical dilation over time will be modeled with best-fit equations.~To assess whether there are significant differences in dilation between the two groups, general linear models will be used, controlling for baseline dilation, baseline bishop score, and parity. To assess whether there are significant differences in composite satisfaction scores between groups, general linear models will be used, controlling for baseline dilation, baseline bishop score, and parity. All hypothesis testing will be carried out at the 95% significance level, unless otherwise specified, with a p value of <.05 accepted as statistically significant. All statistical analyses will be performed in collaboration with the EVMS Healthcare Analytics and Delivery Science Institute (HADSI) using SAS version 9.4 (SAS Institute, Cary, NC).
This is a two-step, prospective study using Dilapan-S for preinduction cervical ripening. Phase one determines what route of ultrasound will be most beneficial to visualize Dilapan-S rods during the induction process. This study will take place on the Labor and Delivery Unit of Sentara Norfolk General Hospital. Only women who have been scheduled for a medical or elective induction can be recruited. Three routes of ultrasound will be conducted in women with gauze placement with the Dilapan-S and without gauze placement with Dilapan-S. This will require 4 extra ultrasound examinations each lasting less than 5 minutes.~In phase two of the study, the purpose is to objectively evaluate the rate of cervical dilation using a predetermined route of ultrasound in women using the preinduction agent, Dilapan-S. This study will establish and project the maximal rate of cervical change to determine what time frame is most beneficial for keeping Dilapan-S insitu during the induction process. It will also objectively establish if the presence of soaked gauze placement with the Dilapan-S affects the rate of Dilapan-S change. At time intervals of approximately 3, 6, 8 and 12 hours, the investigators plan to assess predetermined data collection points with the Dilapan-S in place. Each ultrasound should take a maximum of 5 minutes. The Dilapan-S rods will be removed at hour 12 and the next steps in the induction process will be based on local practice guidelines. Lastly, subjects will be asked to fill out a patient satisfaction survey both immediately after Dilapan-S placement and immediately after Dilapan-S removal.~The primary objective of this study is to determine, by ultrasound, the rate of cervical dilation using DILAPAN-S for pre-induction cervical ripening. The investigators hypothesize that DILAPAN-S will achieve its maximal rate of change in cervical dilation within the first six hours of placement. A secondary aim of this study is to determine whether rates of cervical dilation differ between patients who have gauze inserted with Dilapan-S and patients who do not have gauze inserted. The investigators hypothesize that the change in dilation across time points will be greater in the DILAPAN-S with soaked-gauze group compared with the Dilapan-S only group. The third aim of this study is to assess patient satisfaction scores and determine whether satisfaction scores differ between patients who have gauze inserted with Dilapan-S and patients who do not.