Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)

• ClinicalTrials.gov Identifier: NCT03665688
• Recruitment Status: Completed
• First Posted: September 11, 2018
• Last Update Posted: December 2, 2021
• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborator: Medicem International CR s.r.o.
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

Brief Summary:

The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.

Condition or disease	Intervention/treatment	Phase
Labor, Induced; Cervix Uteri-Diseases	Device: Outpatient Dilapan-S; Device: Inpatient Dilapan-S	Not Applicable

Detailed Description:

Group Assigned to Outpatient Cervical Ripening After Dilapan-S® placement, subject will be monitored for at least 30 minutes. If no contraindications, such as tachysystole, active vaginal bleeding, rupture of membranes or nonreassuring fetal testing (defined as minimal or absent variability, abnormal baseline, or presence of decelerations) evidence of labor, or other serious medical conditions deemed by the clinical staff or the attending physician to preclude outpatient cervical ripening develop after insertion, the subjects will be randomized. After randomization subject will record the pain she experienced during insertion in the patient's survey (see Appendix 3). Those subjects randomized to outpatient ripening will be given the option to either return home or to stay in a hotel if transportation is an issue. The cost for the hotel will be covered by the study budget. Subjects will be allowed to ambulate, shower and perform regular activity during that period. "Nothing per vagina" will be allowed (incl. intercourse, tampons etc.).

Group Assigned to Inpatient Cervical Ripening Subjects randomized to inpatient management will be admitted to L&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.

Labor Induction and Labor Management of the subject after the initial 12 hours of pre-induction or following the earlier removal or spontaneous expulsion of the dilator will be the same for both groups and at the discretion of the clinical team. Additional ripening (mechanical or prostaglandins) and/or oxytocin may or may not be needed. If needed, duration, type and dose of additional ripening agents and oxytocin will be documented.

Routine intrapartum care will be provided and relevant data collected by the subject's managing obstetrical team.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 338 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
• Actual Study Start Date: November 7, 2018
• Actual Primary Completion Date: November 5, 2021
• Actual Study Completion Date: November 5, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Outpatient Dilapan-S; After Dilapan-S® placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours	Device: Outpatient Dilapan-S; After Dilapan-S placement, subjects will be given the option to either return home or to stay in a hotel if transportation is an issue. Subjects will also be instructed to return to L&D unit 12 hours after insertion, or earlier if any excessive bleeding, rupture of membranes, pain or other concerns (contractions, decreased fetal movement) develop before the 12 hours. After the designated 12 hours' time or earlier, if indicated, subjects are to return and to be admitted to L&D unit for standard protocol of labor induction.; Other Name: Outpatient cervical ripening with Dilapan-S
Active Comparator: Inpatient Dilapan-S; After Dilapan-S® placement, subjects will be admitted to L&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.	Device: Inpatient Dilapan-S; After Dilapan-S placement, subjects will be admitted to L&D unit and standard clinical protocol will be initiated for cervical ripening and labor induction. During the period of 12 hours of cervical ripening subject is to remain "nothing per os" (NPO), "nothing per vagina" and undergo continuous fetal heart rate monitoring. No other interventions are to occur during this period of 12 hours, unless clinically indicated.; Other Name: Inpatient cervical ripening with Dilapan-S

Outcome Measures

Primary Outcome Measures :

1. Hospital Stay [ Time Frame: 48hours ]
   Rate of hospital stay longer than 48 hours (from admission to discharge)
2. Healthcare cost impact [ Time Frame: 2-4 days ]
   Healthcare cost impact will be assessed based on direct hospital costs or Medicaid charges, using cost minimization technique.

Secondary Outcome Measures :

1. Vaginal deliveries [ Time Frame: 2-4 days ]
   Rate of vaginal deliveries (%)
2. Vaginal deliveries 24 hrs [ Time Frame: 24 hours ]
   Rate of vaginal deliveries within 24 hours since admission to hospital (%)
3. Vaginal deliveries 36 hrs [ Time Frame: 36 hours ]
   Rate of vaginal deliveries within 36 hours since admission to hospital (%)
4. Admission to active labor [ Time Frame: 1-2 days ]
   Time from hospital admission to reach active stage of labor defined as ≥ 6 cm (mins)
5. Device to active labor [ Time Frame: 1-3 days ]
   Time from device placement to reach active stage of labor defined as ≥ 6 cm (mins)
6. Bishop score change [ Time Frame: 12 hours ]
   Change in Bishop score (based on cervical dilation, position of cervix, effacement of cervix, fetal station and softness of cervix) from insertion to extraction of device
7. Cervical change [ Time Frame: 12 hours ]
   Change in cervical dilation after Dilapan-S
8. Vaginal delivery after one round of mechanical dilator [ Time Frame: 12 hours ]
   Rate of spontaneous vaginal deliveries after one round of cervical ripening (%) (no additional medical or mechanical interventions)
9. Operative vaginal delivery [ Time Frame: 1-4 days ]
   Rate of operative vaginal deliveries (%)
10. Cesarean delivery [ Time Frame: 1-4 days ]
    Rate of caesarean deliveries (%)
11. AROM [ Time Frame: 1-4 days ]
    Rate of artificial rupture of membranes (AROM) (%)
12. Epidural [ Time Frame: 1-4 days ]
    Rate of epidural analgesia (%)
13. Device time [ Time Frame: 12 hours ]
    Total duration of Dilapan-S® application (insertion to removal/extraction) (mins)
14. Device to delivery time [ Time Frame: 1-4 days ]
    Device placement to delivery interval (mins)
15. Induction time [ Time Frame: 48 hours ]
    Induction (Oxytocin/Prostaglandin initiation) to delivery interval (mins)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Pregnant women
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Pregnant woman whose plan of care is induction of labor
2. Maternal age between 18 and 45 years
3. Understanding and capable to sign informed consent
4. Singleton pregnancy
5. Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
6. Live fetus in cephalic presentation
7. Intact membranes
8. Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced

Exclusion Criteria:

1. Active labor
2. Active genital herpes
3. Chorioamnionitis
4. Transfundal uterine or cervical surgery
5. Previous cesarean delivery
6. Non-reassuring fetal status
7. Need for continuous maternal or fetal monitoring during ripening
8. Contraindication for vaginal delivery
9. Active vaginal bleeding
10. Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
11. Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
12. Intrauterine growth restriction (estimated fetal weight <10 percentile)
13. Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
14. Fetal anomaly
15. Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
16. Poor or no access to a telephone and cannot be placed in the hotel
17. Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)

Contacts and Locations

Locations

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

United States, Texas

UTMB Galveston

Galveston, Texas, United States, 77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Medicem International CR s.r.o.

Investigators

• Principal Investigator: Antonio Saad, MD; The University of Texas Medical Branch, Galveston

More Information

Publications:

Thiery M, De Boever J, Merchiers E, Martens G. Hormones and cervical ripening. Am J Obstet Gynecol. 1989 May;160(5 Pt 1):1251-3.

Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; 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 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.

Wilkinson C, Adelson P, Turnbull D. A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial. BMC Pregnancy Childbirth. 2015 May 28;15:126. doi: 10.1186/s12884-015-0550-z.

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 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.

Henry A, Madan A, Reid R, Tracy SK, Austin K, Welsh A, Challis D. Outpatient Foley catheter versus inpatient prostaglandin E2 gel for induction of labour: a randomised trial. BMC Pregnancy Childbirth. 2013 Jan 29;13:25. doi: 10.1186/1471-2393-13-25.

Kruit H, Heikinheimo O, Ulander VM, Aitokallio-Tallberg A, Nupponen I, Paavonen J, Rahkonen L. Foley catheter induction of labor as an outpatient procedure. J Perinatol. 2016 Aug;36(8):618-22. doi: 10.1038/jp.2016.62. Epub 2016 Apr 14.

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 Nov;98(5 Pt 1):751-6.

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 Aug;125(9):1086-1095. doi: 10.1111/1471-0528.15047. Epub 2018 Jan 10.

Gupta J, Chodankar R, Baev O, Bahlmann F, Brega E, Gala A, Hellmeyer L, Hruban L, Maier J, Mehta P, Murthy A, Ritter M, Saad A, Shmakov R, Suneja A, Zahumensky J, Gdovinova D. Synthetic osmotic dilators in the induction of labour-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Oct;229:70-75. doi: 10.1016/j.ejogrb.2018.08.004. Epub 2018 Aug 3.

Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, Harper LM. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):94-101. doi: 10.1097/AOG.0000000000002678.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Aug 27;8:CD007372. doi: 10.1002/14651858.CD007372.pub4.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03665688
• Other Study ID Numbers: 18-0132
• First Posted: September 11, 2018
• Last Update Posted: December 2, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by The University of Texas Medical Branch, Galveston:

Cervical ripening; Labor induction; Outpatient; Mechanical; Hygroscopic

Additional relevant MeSH terms:

Uterine Diseases