200 Participants Needed

Timing of Consent for Cesarean Delivery in Pregnancy

KM
SW
Overseen BySarahn Wheeler, MD, MHSc
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal timing for obtaining consent from pregnant patients for a possible cesarean delivery. Some hospitals request consent upon patient arrival, while others wait until a cesarean becomes necessary. Participants are divided into two groups: one provides early surgical consent upon arrival, and the other gives consent only if medically needed later. The researchers seek pregnant women between 34 and 41 weeks along, receiving care at specific Duke clinics, and planning to be induced for labor. Participants will share their views on the consent process and their overall childbirth experience. As an unphased trial, this study allows participants to contribute to important research that could enhance the childbirth experience for future mothers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the timing of consent for cesarean delivery and does not mention any changes to medication use.

What prior data suggests that this consent timing protocol is safe for patients?

This study examines the timing of consent for a cesarean delivery, rather than testing a new drug or surgery. As it involves no medical procedures or medications, there are no safety concerns related to the treatment itself. The study investigates whether asking for consent earlier or only when a cesarean is needed is preferable. Both options include discussing and signing a standard hospital form about a cesarean delivery. Since the study only alters the timing of consent, participants face no safety risks.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores when surgical consent for a possible cesarean delivery should be obtained during labor. Unlike the traditional approach, where consent is typically obtained only if a cesarean becomes necessary, this study looks at giving consent early, right when labor is induced. This could potentially streamline the process, reduce stress for expectant mothers, and provide more time for informed decision-making. By comparing early consent to the usual practice, researchers hope to discover which method better supports patient care and decision-making during labor.

What evidence suggests that this trial's consent timing methods could optimize the cesarean delivery experience?

This study does not test the effectiveness of a new treatment. Instead, it aims to determine the best time to discuss obtaining patient consent for a possible cesarean delivery (C-section) during childbirth. Participants will be randomized into two groups: one group will provide surgical consent for a possible C-section upon arrival for labor induction, while the other group will give consent only if a C-section becomes clinically indicated during labor. Research on labor induction shows mixed results regarding its impact on C-section rates. Some studies suggest that inducing labor might reduce the need for a C-section, while others indicate it might not significantly affect the outcome. This study does not alter the medical care received; it only changes the timing of the consent discussion for a possible C-section. The goal is to enhance the childbirth experience by identifying the optimal time for this conversation.12467

Who Is on the Research Team?

RB

Rebecca Beal

Principal Investigator

Duke University Department of Obstetrics and Gynecology

KW

Kristin Weaver

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who are 18 or older, receiving prenatal care at specific Duke health centers, and between 34 to 41 weeks of gestation. It's focused on those intending vaginal delivery but may need an unplanned cesarean.

Inclusion Criteria

I am 18 years old or older.
I am receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates.
I am between 34 and 41 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Consent Process

Participants are randomized to either early consent for possible cesarean delivery upon admission or consent if clinically indicated during labor

During labor and delivery
1 visit (in-person)

Postpartum Survey

Participants complete a survey about their experience with the surgical consent process and overall childbirth experience

From day 1 postpartum to 6 weeks postpartum
Survey (virtual)

Follow-up

Participants are monitored for safety and effectiveness after delivery

6 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Early Surgical Consent
  • Surgical Consent if Clinically Indicated
Trial Overview The study is testing when to get consent for a possible cesarean delivery: either upon hospital admission or only if it becomes clinically necessary. Participants will be randomly assigned to one of these two approaches.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Consent for Possible Cesarean DeliveryExperimental Treatment1 Intervention
Group II: Indicated Consent for Possible Cesarean DeliveryActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Citations

Optimizing Timing of Cesarean Delivery Consent on Labor ...This study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean ...
Labor Induction versus Expectant Management in Low- ...The primary outcome occurred in 4.3% of neonates in the induction group and in 5.4% in the expectant-management group (relative risk, 0.80; 95% ...
Induction of Labor - StatPearls - NCBI Bookshelf - NIHResults demonstrated a significantly lower cesarean section rate in the induction group and no statistically lower adverse perinatal outcomes.
Induction of labour in patients with prior caesarean births or ...A high vaginal birth rate of around 60% can be achieved following induction after previous caesarean. •. IOL is associated with a lower vaginal birth rate and ...
The role of labor induction in modern obstetricsIn fact, there is a wealth of evidence from randomized trials that labor induction compared with expectant management does not increase and may ...
Induction of labor vs expectant management among low ...Studies that have compared induction of labor in individuals with 1 prior cesarean delivery to expectant management have shown conflicting results.
Labor induction doesn't always reduce caesarean birth risk or ...Expectantly managed women and birthing individuals were also less likely to have a postpartum hemorrhage (8% versus 10%) or operative vaginal ...
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