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| Name | Class |
|---|---|
| Northwell Health | OTHER |
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This is a randomized prospective trial of two mechanical methods of pre-induction cervical ripening agents.
Term, low risk patients requesting elective induction of labor who desire pre-induction cervical ripening at home will be randomized to receive an outpatient trans-cervical ripening balloon (17 F non-latex Foley catheter) or hygroscopic cervical dilator (Dilapan-S). Patients present to the hospital for their scheduled induction of labor approximately 12 hours later.
We hypothesize that the trans-cervical balloon and hygroscopic dilators will show equivalent efficacy in cervical ripening, but that pain scores and patient satisfaction will be better with the hygroscopic dilators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-cervical cervical balloon | Experimental | 17 F non-latex Foley catheter will be placed and balloon filled with 30 cc of sterile normal saline. |
|
| Hygroscopic cervical dilators | Experimental | Dilapan-S hygroscopic dilators will be placed into the cervix at the level of the internal os. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-cervical cervical balloon | Device | Insertion of Foley Catheter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time from start of cervical ripening to delivery | Time in minutes from placement of cervical ripening agent to delivery | 720-2160 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Pain of insertion | Patient assessment of pain on insertion using pain analog scale | First hour |
| Pain over duration of cervical ripening | Patient assessment of pain on admission using pain analog scale |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device expulsion prior to admission | Number of patients reporting expulsion of the device prior to planned admission | 12-14 hours |
| Rate of onset of labor prior to planned admission | Number of patients presenting in active labor prior to planned admission divided by all enrolled patients |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brigid McCue, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Baptist Hospital | New Orleans | Louisiana | 70115 | United States | ||
| Brigid McCue |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11704164 | Background | 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. | |
| 24347259 | Background | Sciscione AC, Bedder CL, Hoffman MK, Ruhstaller K, Shlossman PA. The timing of adverse events with Foley catheter preinduction cervical ripening; implications for outpatient use. Am J Perinatol. 2014 Oct;31(9):781-6. doi: 10.1055/s-0033-1359718. Epub 2013 Dec 17. |
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| Hygroscopic cervical dilator |
| Device |
Insertion of Dilapan-s |
|
| 12-14 hours |
| Patient satisfaction with cervical ripening agent | Patient survey postpartum day #1 regarding cervical ripening experience | 24-36 hours |
| 12-14 hours |
| Rate of cesarean delivery | Number of patients requiring cesarean delivery divided by number of all enrolled patients | 12-36 hours |
| Rate of operative vaginal delivery | Number of patients requiring operative vaginal delivery divided by number of all enrolled patients | 12-36 hours |
| Incidence of shoulder dystocia | Number of patients diagnosed with shoulder dystocia divided by number of all enrolled patients | 12-36 hours |
| Incidence of intra-amniotic infection | Number of patients diagnosed with intra-amniotic infection (maternal temperature >38C, maternal (>120) or fetal (>160) tachycardia) divided by number of all enrolled patients | 12-36 hours |
| Incidence of post-partum hemorrhage | Number of patients diagnosed with post-partu hemorrhage (QBL >1000 ml) divided by number of all enrolled patients | 12-36 hours |
| 10 minute Apgar score <7 | Number of infants with 10 minute Apgar score <7 divided by number of all enrolled patients | 12-36 hours |
| Base excess >12 | Number of infants with base excess >12 divided by number of all enrolled patients | 12-36 hours |
| Umbilical cord gas pH <7 | Number of infants with umbilical cord gas <7 divided by number of all enrolled patients | 12-36 hours |
| Composite score of adverse neonatal outcomes | Composite of perinatal adverse outcomes (the need for respiratory support within 72 hours after birth, Apgar score of 3 or less at 5 minutes, hypoxic-ischemic encephalopathy, seizure, infection (confirmed sepsis or pneumonia), aspiration syndrome, birth trauma (bone fracture, neurologic injury, or retinal hemorrhage), intracranial or subgaleal hemorrhage, or hypotension requiring vasopressor support) | 12-72 hours |
| Composite score of serious maternal morbidity or mortality | Composite score of serious maternal morbidity (e.g. uterine rupture, admission to intensive care unit, septicemia), or death. | 12-72 hours |
| Bay Shore |
| New York |
| 11706 |
| United States |
| 8694040 | Background | Gilson GJ, Russell DJ, Izquierdo LA, Qualls CR, Curet LB. A prospective randomized evaluation of a hygroscopic cervical dilator, Dilapan, in the preinduction ripening of patients undergoing induction of labor. Am J Obstet Gynecol. 1996 Jul;175(1):145-9. doi: 10.1016/s0002-9378(96)70264-8. |
| 29272277 | Background | Shindo R, Aoki S, Yonemoto N, Yamamoto Y, Kasai J, Kasai M, Miyagi E. Hygroscopic dilators vs balloon catheter ripening of the cervix for induction of labor in nulliparous women at term: Retrospective study. PLoS One. 2017 Dec 22;12(12):e0189665. doi: 10.1371/journal.pone.0189665. eCollection 2017. |
| 29889751 | Result | 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. |
| 38417552 | Derived | Lu AMR, Lin B, Shahani D, Demertzis K, Muscat J, Zabel E, Olson P, Manayan O, Nonnamaker E, Fest J, McCue B. Randomized control trial comparing hygroscopic cervical dilators to cervical ripening balloon for outpatient cervical ripening. Am J Obstet Gynecol MFM. 2024 Apr;6(4):101318. doi: 10.1016/j.ajogmf.2024.101318. Epub 2024 Feb 28. |
| 36996264 | Derived | de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4. |