Labor, Induced Clinical Trial
— HOMECAREOfficial title:
Induction of Labor in Women With Unfavorable Cervix: Randomized Controlled Trial Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S® (HOMECARE)
Verified date | July 2023 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 338 |
Est. completion date | November 5, 2021 |
Est. primary completion date | November 5, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | UTMB Galveston | Galveston | Texas |
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | Medicem International CR s.r.o. |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With Vaginal Deliveries 2-4 Days | Rate of vaginal deliveries (%) | 2-4 days | |
Secondary | Number of Participants With Vaginal Deliveries - 24 Hours | Rate of vaginal deliveries within 24 hours since admission to hospital (%) | 24 hours | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of Participants With Operative Vaginal Delivery | Rate of operative vaginal deliveries (%) | 1-4 days | |
Secondary | Number of Participants With Cesarean Delivery | Rate of caesarean deliveries (%) | 1-4 days |
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