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

Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)

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.

Study Overview

• Status: Completed
• Conditions: Labor, Induced; Cervix Uteri-Diseases
• Intervention / Treatment: Device: Outpatient Dilapan-S; Device: Inpatient Dilapan-S

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 Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
  • Texas
    • Galveston, Texas, United States, 77555
      • UTMB Galveston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Inpatient cervical ripening with Dilapan-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Hospital Stay Longer Than 48 Hours	Rate of hospital stay longer than 48 hours (from admission to discharge)	72 hours or discharge home time, whichever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Vaginal Deliveries 2-4 Days	Rate of vaginal deliveries (%)	2-4 days
Number of Participants With Vaginal Deliveries - 24 Hours	Rate of vaginal deliveries within 24 hours since admission to hospital (%)	24 hours
Time From Hospital Admission to Active Stage of Labor	Time from hospital admission to reach active stage of labor defined as cervical dilation of ≥ 6 cm (in minutes)	1-2 days
Change in Bishop Score From Insertion of Device to Extraction	Change in Bishop score (based on cervical dilation, position of cervix, effacement of cervix, fetal station and softness of cervix) . Calculated as Bishop score value at 12 hours minus value at baseline. Bishop score ranges from zero to 13, with zero meaning you're not ready for induction and 13 indicating a better chance for successful induction. A higher score means that labor is closer, and that induction has a good chance of being successful.	12 hours
Number of Participants With Operative Vaginal Delivery	Rate of operative vaginal deliveries (%)	1-4 days
Number of Participants With Cesarean Delivery	Rate of caesarean deliveries (%)	1-4 days

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Medicem International CR s.r.o.
• Investigators: Principal Investigator: Antonio Saad, MD, The University of Texas Medical Branch, Galveston

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0029-7844(01)01579-4.
• 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(8):CD007372. doi: 10.1002/14651858.CD007372.pub4.
• 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.
• 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.
• 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.
• 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.
• 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. doi: 10.1016/0002-9378(89)90207-x. No abstract available.
• 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 E(2) (OPRA study). BJOG. 2015 Jan;122(1):94-104. doi: 10.1111/1471-0528.12846. Epub 2014 May 14.
• 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.
• 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.
• Saad AF, Gavara R, Senguttuvan RN, Goncharov AD, Berry M, Eid J, Goldman B, Nutter A, Moutos CP, Wang AM, Saade GR. Outpatient Compared With Inpatient Preinduction Cervical Ripening Using a Synthetic Osmotic Dilator: A Randomized Clinical Trial. Obstet Gynecol. 2022 Oct 1;140(4):584-590. doi: 10.1097/AOG.0000000000004942. Epub 2022 Sep 7.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Outpatient; Mechanical; Cervical ripening; Labor induction; Hygroscopic
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Diseases
• Other Study ID Numbers: 18-0132

Drug and device information, study documents

• 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