Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

NCT07117708 | Recruiting

• 1 other identifier: Pro00117303
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Informed Consent

Keywords

pregnancy; informed consent

Outcome Measures

Primary Outcomes (1)

• Patient Perception of Informed Consent Process

  As measured by survey.

  From day 1 postpartum to 6 weeks postpartum

Secondary Outcomes (1)

• Patient Childbirth Experience

  From day 1 postpartum to 6 weeks postpartum

Study Arms (2)

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.

Other: Early Surgical Consent

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.

Other: Surgical Consent if Clinically Indicated

Interventions

Early Surgical Consent OTHER

Surgical consent for possible cesarean delivery will be completed upon arrival to labor and delivery before induction of labor begins

Early Consent for Possible Cesarean Delivery

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.

Indicated Consent for Possible Cesarean Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates
• Between 34 weeks 0 days and 41 weeks 0 days of gestation
• Scheduled for induction of labor OR are eligible/intend to be scheduled for an induction of labor

You may not qualify if:

• Trial of labor after cesarean delivery
• Multiple gestation
• Major fetal anomalies
• Presenting for induction of labor as a transfer from the antepartum inpatient service
• Non-English speaking
• Those who do not intend to labor
• Patients who are ineligible for vaginal delivery for other reasons, including fetal malpresentation or abnormal placentation

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 32945733 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.

  PMID: 20510800 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.

  PMID: 23659991 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.

  PMID: 22554992 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.

  PMID: 15383117 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.

  PMID: 8688110 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.

  PMID: 35364294 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.

  PMID: 9351412 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.

  PMID: 16176853 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.

  PMID: 21380993 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.

  PMID: 27193995 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.

  PMID: 38625869 BACKGROUND

Study Officials

• Rebecca Beal

  Duke University Department of Obstetrics and Gynecology

  STUDY DIRECTOR

• Kristin Weaver

  Duke University

  STUDY DIRECTOR

Central Study Contacts

Sarahn Wheeler, MD, MHSc

CONTACT

919-681-5220; Sarahn.wheeler@duke.edu

Kelsey McNew, MD, PhD

CONTACT

kelsey.mcnew@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)