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PregnancyNCT07117708

Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

A study testing Early Surgical Consent and Surgical Consent if Clinically Indicated in people with Pregnancy and Informed Consent, run by Duke University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnancy, Informed Consent
What is being tested?
Early Surgical Consent and Surgical Consent if Clinically Indicated
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
27 Aug 2025to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarahn Wheeler, MD, MHSc contact

919-681-5220

Sarahn.wheeler@duke.edu

Kelsey McNew, MD, PhD contact

kelsey.mcnew@duke.edu

United States1 site, 1 recruiting

  • Duke University

    Durham, North Carolina, 27705

    Sarahn Wheeler, 9196815220, sarahn.wheeler@duke.edu

    Recruiting

Other trials in United States

About this study

Official title: The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery

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.

Read the detailed description

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.

Being tested
Early Surgical Consent, Surgical Consent if Clinically Indicated
Keywords
pregnancy, informed consent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Surgical ConsentOther

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

  • Surgical Consent if Clinically IndicatedOther

    Surgical consent for possible cesarean delivery will be completed if it appears clinically indicated during a participant's induction of labor.

Study groups in NCT07117708
Study groupRoleWhat they receive
Early Consent for Possible Cesarean DeliveryExperimentalPatients 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.
Receives: Other: Early Surgical Consent
Indicated Consent for Possible Cesarean DeliveryActive comparatorPatients 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.
Receives: Other: Surgical Consent if Clinically Indicated

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Perception of Informed Consent Process

    As measured by survey.

    Measured: From day 1 postpartum to 6 weeks postpartum

Secondary outcomes (1)

  1. Patient Childbirth Experience

    As measured by survey.

    Measured: From day 1 postpartum to 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2025
  2. Study start27 Aug 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07117708
Sponsor's protocol ID
Pro00117303
Status last verified
Aug 2025
First submitted
5 Aug 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32945733

  • 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.

    PubMed 20510800

  • 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.

    PubMed 23659991

  • 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.

    PubMed 22554992

  • 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.

    PubMed 15383117

  • 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.

    PubMed 8688110

  • 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.

    PubMed 35364294

  • 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.

    PubMed 9351412

  • 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.

    PubMed 16176853

  • 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.

    PubMed 21380993

  • 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.

    PubMed 27193995

  • 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.

    PubMed 38625869

Questions about this trial

What is this clinical trial studying?

A study testing Early Surgical Consent and Surgical Consent if Clinically Indicated in people with Pregnancy and Informed Consent, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarahn Wheeler, MD, MHSc (919-681-5220, Sarahn.wheeler@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Perception of Informed Consent Process (time frame: From day 1 postpartum to 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07117708, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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