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Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated.
This study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.
This study is a randomized-controlled trial in which patients presenting to Labor and Delivery for their scheduled induction of labor will be randomized to either be consented for possible cesarean delivery on admission to Labor and Delivery or be consented for possible cesarean delivery if it appears to be clinically indicated (as is current standard of care). The purpose of this study is to understand whether earlier cesarean delivery consent could be one strategy to improve the delivery experience of patients recommended to undergo unplanned cesarean delivery and enhance education for all birthing patients. The proposed study will fill this gap in the literature by determining whether early informed surgical consent reduces negative patient delivery experiences and address concerns about the mechanism of obtaining informed consent for cesarean delivery.
Duke Perinatal Durham or Duke Women's Health Associates patients will be approached to be consented for the research study between 34-41 weeks of pregnancy. Those who agree to participate will be randomized to either an early surgical consent for possible cesarean delivery at the time of admission to Labor and Delivery or, as per our current standard of care, will be surgically consented for cesarean delivery if it is clinically indicated. On postpartum day 1, patients will be texted a link to a survey about their experience with the surgical consent process and their overall childbirth experience. The investigators will collect additional patient information via chart review, including a patient's medical history and information about their labor, delivery, and postpartum courses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Consent for Possible Cesarean Delivery | Experimental | Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery upon arrival to labor and delivery for the start of their induction of labor. |
|
| Indicated Consent for Possible Cesarean Delivery | Active Comparator | Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery only if it appears to be clinically indicated throughout their induction of labor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Surgical Consent | Other | Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perception of Informed Consent Process | As measured by survey. | From day 1 postpartum to 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Childbirth Experience | As measured by survey. | From day 1 postpartum to 6 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarahn Wheeler, MD, MHSc | Contact | 919-681-5220 | Sarahn.wheeler@duke.edu | |
| Kelsey McNew, MD, PhD | Contact | kelsey.mcnew@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca Beal | Duke University Department of Obstetrics and Gynecology | Study Director |
| Kristin Weaver | Duke University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32945733 | Background | Burcher P, Hushmendy S, Chan-Mahon M, Dasani M, Gabriel J, Crosby E. Unplanned Cesarean Birth: Can the Quality of Consent Affect Birth Experiences? AJOB Empir Bioeth. 2020 Oct-Dec;11(4):268-274. doi: 10.1080/23294515.2020.1817174. Epub 2020 Sep 18. | |
| 20510800 | Background | Fink AS, Prochazka AV, Henderson WG, Bartenfeld D, Nyirenda C, Webb A, Berger DH, Itani K, Whitehill T, Edwards J, Wilson M, Karsonovich C, Parmelee P. Predictors of comprehension during surgical informed consent. J Am Coll Surg. 2010 Jun;210(6):919-26. doi: 10.1016/j.jamcollsurg.2010.02.049. |
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| Surgical Consent if Clinically Indicated | Other | Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor. |
|
| 23659991 | Background | Salmeen K, Brincat C. Time from consent to cesarean delivery during labor. Am J Obstet Gynecol. 2013 Sep;209(3):212.e1-6. doi: 10.1016/j.ajog.2013.05.004. Epub 2013 May 6. |
| 22554992 | Background | Odumosu M, Pathak S, Barnet-Lamb E, Akin-Deko O, Joshi V, Selo-Ojeme D. Understanding and recollection of the risks associated with cesarean delivery during the consent process. Int J Gynaecol Obstet. 2012 Aug;118(2):153-5. doi: 10.1016/j.ijgo.2012.03.025. Epub 2012 May 1. |
| 15383117 | Background | Akkad A, Jackson C, Kenyon S, Dixon-Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. BJOG. 2004 Oct;111(10):1133-8. doi: 10.1111/j.1471-0528.2004.00240.x. |
| 8688110 | Background | Lescale KB, Inglis SR, Eddleman KA, Peeper EQ, Chervenak FA, McCullough LB. Conflicts between physicians and patients in non-elective cesarean delivery: incidence and the adequacy of informed consent. Am J Perinatol. 1996 Apr;13(3):171-6. doi: 10.1055/s-2007-994319. |
| 35364294 | Background | Levy KS, Smith MK, Lacroix M, Yudin MH. Patient Satisfaction with Informed Consent for Cesarean and Operative Vaginal Delivery. J Obstet Gynaecol Can. 2022 Jul;44(7):785-790. doi: 10.1016/j.jogc.2022.03.010. Epub 2022 Mar 29. |
| 9351412 | Background | Ryding EL, Wijma B, Wijma K. Posttraumatic stress reactions after emergency cesarean section. Acta Obstet Gynecol Scand. 1997 Oct;76(9):856-61. doi: 10.3109/00016349709024365. |
| 16176853 | Background | Olde E, van der Hart O, Kleber R, van Son M. Posttraumatic stress following childbirth: a review. Clin Psychol Rev. 2006 Jan;26(1):1-16. doi: 10.1016/j.cpr.2005.07.002. Epub 2005 Sep 19. |
| 21380993 | Background | Blomquist JL, Quiroz LH, Macmillan D, McCullough A, Handa VL. Mothers' satisfaction with planned vaginal and planned cesarean birth. Am J Perinatol. 2011 May;28(5):383-8. doi: 10.1055/s-0031-1274508. Epub 2011 Mar 4. |
| 27193995 | Background | Smarandache A, Kim TH, Bohr Y, Tamim H. Predictors of a negative labour and birth experience based on a national survey of Canadian women. BMC Pregnancy Childbirth. 2016 May 18;16(1):114. doi: 10.1186/s12884-016-0903-2. |
| 38625869 | Background | Osterman MJK, Hamilton BE, Martin JA, Driscoll AK, Valenzuela CP. Births: Final Data for 2022. Natl Vital Stat Rep. 2024 Apr;73(2):1-56. |