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A randomized trial of patients undergoing a term (≥37 weeks) induction of labor with a history of one prior Cesarean delivery, wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing Foley alone with concurrent Foley and Oxytocin use at the start of the induction. With this trial, the investigators aim to test our central hypothesis that concurrent Foley and Oxytocin will decrease time to delivery without increasing risks, compared to Foley alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent Foley balloon and Oxytocin | Experimental | Cervical ripening will begin with a Foley balloon and concurrent oxytocin, started within 2 hour of balloon placement |
|
| Foley balloon alone | Active Comparator | Cervical ripening will begin with a Foley balloon alone. Oxytocin will not be started until the balloon is removed or expelled, though can be considered if the balloon remains in place for >8 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Foley balloon | Device | Foley balloon for induction of labor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to delivery | The primary endpoint will be time from start of induction until delivery (hours) | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated postpartum blood loss | Estimated postpartum blood loss in mL | At delivery |
| Postpartum hemorrhage | Estimated blood loss≥ 1L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Levine, MD MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18929686 | Background | Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. | |
| 10480822 | Background |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Oxytocin | Drug | Pitocin for induction of labor |
|
|
| Within 6 weeks of delivery |
| Number of Participants with Chorioamnionitis | Documented chorioamnionitis | At delivery |
| Mode of delivery | Successful vaginal birth after cesarean (VBAC) or repeat cesarean delivery (rCD) | At delivery |
| Number of Participants with Uterine Rupture | Uterine rupture noted at the time of cesarean delivery | At delivery |
| Maternal morbidity | Defined as a composite endpoint consisting of at least one occurrence of the following outcomes: postpartum hemorrhage, blood transfusion, endometritis, wound/laceration breakdown or infection, venous thromboembolism and hospital readmission with 6 weeks | Within 6 weeks of delivery |
| Neonatal morbidity | Defined as neonatal resuscitation requiring supplemental oxygen outside of the delivery room for at least 12 hours of culture proven/presumed neonatal sepsis | Within 6 weeks of delivery |
| Maternal length of stay | Measured by hours from admission to postpartum discharge | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery |
| Neonatal length of stay | Length of stay from birth to discharge, measured in hours | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery |
| NICU stay greater than 48 hours | Admission to the NICU for more than 48 hours | From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery |
| Maternal patient satisfaction as measured by the Hollins Martin Birth Satisfaction scale-Revised (BSS-R) | Patient satisfaction as measured by the BSS-R with a possible score of 0-40 with 0 equaling the least birth satisfaction | From time of delivery to discharge from hospital, up to 6 weeks from delivery |
| Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670. |
| 20332509 | Background | Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332. |
| 31645154 | Background | Levine LD, Downes KL, Hamm RF, Srinivas SK. Evaluating the impact of a standardized induction protocol to reduce adverse perinatal outcomes: a prospective cohort study. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3200-3207. doi: 10.1080/14767058.2019.1680629. Epub 2019 Oct 24. |
| 28937571 | Background | Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. |
| 35869943 | Background | Jamaluddin A, Azhary JMK, Hong JGS, Hamdan M, Tan PC. Early versus delayed amniotomy with immediate oxytocin after Foley catheter cervical ripening in multiparous women with labor induction: A randomized controlled trial. Int J Gynaecol Obstet. 2023 Feb;160(2):661-669. doi: 10.1002/ijgo.14361. Epub 2022 Aug 8. |
| 35135684 | Background | Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6. |
| 34708257 | Background | Secchi D, Alberic J, Gobillot S, Ghenassia A, Roustit M, Chauleur C, Hoffmann P, Raia-Barjat T. Balloon catheter vs oxytocin alone for induction of labor in women with one previous cesarean section and an unfavorable cervix: a multicenter, retrospective study. Arch Gynecol Obstet. 2022 Aug;306(2):379-387. doi: 10.1007/s00404-021-06298-y. Epub 2021 Oct 28. |
| 26365010 | Background | Hoffman MK, Hunter Grant G. Induction of labor in women with a prior cesarean delivery. Semin Perinatol. 2015 Oct;39(6):471-4. doi: 10.1053/j.semperi.2015.07.011. Epub 2015 Sep 11. |
| 28599068 | Background | West HM, Jozwiak M, Dodd JM. Methods of term labour induction for women with a previous caesarean section. Cochrane Database Syst Rev. 2017 Jun 9;6(6):CD009792. doi: 10.1002/14651858.CD009792.pub3. |
| 27521597 | Background | Kehl S, Weiss C, Rath W. Balloon catheters for induction of labor at term after previous cesarean section: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2016 Sep;204:44-50. doi: 10.1016/j.ejogrb.2016.07.505. Epub 2016 Aug 3. |
| 35751576 | Background | Levin G, Tsur A, Burke YZ, Meyer R. Methods of induction of labor after cesarean with no prior vaginal delivery-Perinatal outcomes. Int J Gynaecol Obstet. 2023 Feb;160(2):612-619. doi: 10.1002/ijgo.14318. Epub 2022 Jul 14. |
| 15598960 | Background | Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med. 2004 Dec 16;351(25):2581-9. doi: 10.1056/NEJMoa040405. Epub 2004 Dec 14. |
| 38462257 | Background | Deshmukh U, Denoble AE, Son M. Trial of labor after cesarean, vaginal birth after cesarean, and the risk of uterine rupture: an expert review. Am J Obstet Gynecol. 2024 Mar;230(3S):S783-S803. doi: 10.1016/j.ajog.2022.10.030. Epub 2023 Jul 13. |
| 19623003 | Background | ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available. |
| 36701618 | Background | Bruno AM, Allshouse AA, Metz TD. Trends in Attempted and Successful Trial of Labor After Cesarean Delivery in the United States From 2010 to 2020. Obstet Gynecol. 2023 Jan 1;141(1):173-175. doi: 10.1097/AOG.0000000000004998. Epub 2022 Nov 30. |
| 30681543 | Background | ACOG Practice Bulletin No. 205: Vaginal Birth After Cesarean Delivery. Obstet Gynecol. 2019 Feb;133(2):e110-e127. doi: 10.1097/AOG.0000000000003078. |
| 36219002 | Background | Stephenson J. Rate of First-time Cesarean Deliveries on the Rise in the US. JAMA Health Forum. 2022 Jul 1;3(7):e222824. doi: 10.1001/jamahealthforum.2022.2824. No abstract available. |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |