Comparing Harms of Vaginal and Cesarean Birth:

Maternity Center Associations Systematic Review & Education & Quality Improvement Campaign
Carol Sakala, PhD, MSPH Maureen P. Corry, MPH Maternity Center Association June 2005
[Maternity Center Associations name changed to Childbirth Connection on 1/1/2006. All documents referenced in these slides are available through Childbirth Connections redesigned expanded website at http://www.childbirthconnection.org. Speaking points are available in Notes view. Download source for this file: http://www.childbirthconnection.org/article.asp?ck=10271&ClickedLink=200&area=2 2006 Childbirth Connection. All rights reserved.]

Maternity Center Association (MCA)

Improving maternity care since 1918 Key audiences: childbearing women, health professionals Evidence-based maternity care focus, 1999www.maternitywise.org

Maternity Center Association Mission

To promote safe, effective and satisfying maternity care for all women and their families through research, education and advocacy

Maternity Center Association Major Program Areas

Maternity Wise website Listening to Mothers Initiative Labor Pain Initiative Labor Support Initiative Cesarean Alert Initiative
See many related resources at www.maternitywise.org

Context for Decision to Focus on Cesarean Section

Rapid Shifts in Belief, Including New Ideas
Vaginal birth is harmful. Vaginal birth is causing pelvic floor problems, after birth and later in life. Having a cesarean will prevent later life pelvic floor problems. The benefit/harm ratio is shifting to equipoise or now favors cesarean. Cesarean delivery, especially elective cesarean, is safe.

Context for Decision to Focus on Cesarean Section (cont)

Rapid Shifts in Practice
cesarean rate rising exponentially (est. 30% or higher now) cesarean rate rising for all indications, all populations new indications for cesarean increased use of planned elective cesarean and labor cesareans without indication* vaginal, VBAC, instrumental rates falling off
* Declercq et al, BMJ (2005); Kalish et al. Obstetrics & Gynecology (2004);Declercq et al., American Journal of Public Health (in press)

Context for Decision to Focus on Cesarean Section (cont)

Rapid Change Without Benefit of a Systematic Look at the Evidence
some systematic reviews for specific indications (e.g., previous cesarean) no attempt to understand full range of harms that differ narrative reviews generally appear to make case for or against casual/liberal use of cesarean narrative reviews are unreliable!

Context for Decision to Focus on Cesarean Section (cont)

ACOG Committee on Ethics, 2003 Committee Opinion Surgery and Patient Choice
The ethical evaluation is clouded by the limitations of data regarding relative short- and long-term risks and benefits of cesarean versus vaginal delivery. If the physician believes that [elective] cesarean delivery promotes the overall health and welfare of the woman and her fetus more than vaginal birth, he or she is ethically justified in performing a cesarean delivery.

Context for Decision to Focus on Cesarean Section (cont)

Confusion and Controversy Among Professionals
Professionals divided, uncertain how to help pregnant women make sense of the issues Large practice variation for many indications: gray areas that could benefit from better understanding of associated harms

Large practice variation across hospitals: NYC 2002 hospital cesarean rates ranged from 10% to 37% (see www.choicesinchildbirth.org)

Context for Decision to Focus on Cesarean Section (cont)

Confusion and Controversy Among Women, General Public
Media coverage incomplete, misleading, potentially inaccurate
Informed consent, and informed refusal, not possible without full and accurate information

MCAs Plan in Response

Invite participation of multi-disciplinary partners Carry out systematic review Develop brochure to help inform pregnant women about the issues Plan media outreach about review results and availability of brochure
Plan online resources for women

Partnership
Invitations sent to national non-profits in the field, to participate in one or more ways:
provide feedback on initial proposal send relevant documents that group has prepared provide feedback on review document and draft brochure consider endorsing revised brochure consider participating in media outreach

Many groups participated in one or (mostly) multiple ways

Partnership (cont)
Review and booklet reflect input and support from:
obstetricians family physicians pediatricians midwives nurses childbirth educators doulas researchers advocates consumers

Multidisciplinary = high-quality products, exciting process

Systematic Review Protocol Scope

Focus on comparing harms (benefits depend upon specific indications and may be well understood through available sources)
Core question: what adverse outcomes differ between cesarean and vaginal birth? Consider various comparisons, as harms may vary:
cesarean or vaginal overall planned or unplanned cesarean spontaneous or instrumental vaginal birth

Systematic Review Protocol Scope (cont)

What Outcomes to Include?
Anything clinically relevant or mother relevant what mothers may want to know about:
maternal and infant/child shorter- or longer-term physical and mental health mother-baby relationship, attachment, breastfeeding

Exclude surrogate markers, as we dont know what they mean for lives of mothers, babies

Systematic Review Protocol Process

Use Oxford Centre for Evidence-based Medicine Research Grading System Include best identified research in review
Level 1: rarely available for review questions Level 2 and/or 3: best identified and included evidence for most outcomes; better quality observational studies and systematic reviews of observational studies Level 4: include only when nothing else found Level 5 (incl. narrative reviews): lowest, exclude
www.cebm.net/levels_of_evidence.asp

Additional Review Questions

What is the relationship between mode of delivery and pelvic floor dysfunction? What factors contribute to pelvic floor dysfunction?
method of delivery other obstetric practices maternal and fetal factors non-obstetric factors

Important for women: understand factors contributing to pelvic floor problems, especially modifiable ones

Additional Review Question

In light of very broad practice variation and uncertainty about optimal rates: Do high rates of cesarean or instrumental birth confer benefits relative to more conservative use?

Challenge: Balancing Needs Against Resources

Large agenda
series of relevant and interrelated questions many potential outcomes that may differ by method of delivery and be important to women

Belief and practice shifting very rapidly

Finite resources and no external funding in hand

Solution: Balancing Needs Against Resources

Apply Guidelines to Limit Scope of Work
Identify series of recent narrative reviews by respected leaders with diverse conclusions Limit studies for possible inclusion to citations in these narrative reviews citations in draft of closely related UK National Institute for Clinical Excellence Review 2 MEDLINE searches for most current material searches in 2 databases of systematic reviews abstracts/articles on file with MCA English language

Solution (cont): Balancing Needs Against Resources

MCA had initiated dialogue with Agency for Healthcare Research and Quality (AHRQ) about need for full evidence report on these matters through their Evidence-based Practice program

MCA would continue this dialogue

Systematic Review, in Summary: Limiting Bias, Having Credible Results

Established guidelines in advance Made them transparent, and adhered to them

Scrupulously used these criteria and not study results to decide whether to include or exclude a study
Summarized results of included studies Unique contribution: goal of full accounting of differences in harm achieved by validated systematic procedures

Results Overall
Over 300 research reports evaluated for inclusion in review, described in evidence tables
Included studies described dozens outcomes related to key review questions, which were incorporated into an outline of key questions Outline of questions and outcomes used as framework for developing evidence tables with details of studies

Results Overall (cont)

PDF files available online:
methods and sources document outline of questions and outcomes full evidence tables summary of results for professionals
See www.maternitywise.org/prof/cesarean/

In preparation:
manuscripts for professional journals

Results Overall (cont)

Many adverse effects appear to differ by mode of delivery Overall, results strongly favor vaginal birth Vaginal instrumental delivery associated with series of adverse effects (could limit harm by avoiding episiotomy and offering cesarean late vs. difficult instrumental birth) Overall, spontaneous vaginal birth is associated with fewest harms

Consumer booklet, results summary for professionals, and manuscripts report absolute risk differences when available through included studies

Shorter-term Harms of Cesarean to Mothers

In comparison with vaginal birth, increased harm due to:
death, related to surgery or anesthesia (rare) emergency hysterectomy blood clots and stroke injuries from surgery longer hospitalization rehospitalization infection severe and long-lasting pain

Social & Emotional Harms of Cesarean to Mothers

In comparison with vaginal birth, increased harm due to:
poor birth experience less early contact with baby early unfavorable reaction to baby psychological trauma (unplanned cesarean) depression?? poor overall mental health and self-esteem poor overall functioning

Ongoing Physical Harms of Cesarean to Mothers

In comparison with vaginal birth, increased harm due to:
ongoing pelvic pain bowel obstruction

(due to scar tissue and adhesions)

Harms of Cesarean to Babies

In comparison with vaginal birth, increased harm due to:
accidental cuts during surgery mild to severe respiratory problems not initiating breastfeeding asthma, in childhood and adulthood

Harms of Cesarean to Mothers in Future Pregnancies

In comparison with vaginal birth, increased harms due to:
infertility involuntary infertility voluntary ectopic pregnancy/cesarean scar pregnancy

Harms of Cesarean to Mothers in Future Pregnancies (cont)

In comparison with vaginal birth, increased harms due to:
placenta previa placenta accreta placental abruption uterine rupture maternal death

Harms of Cesarean to Babies in Future Pregnancies

In comparison with vaginal birth, increased harms due to:
death, before or shortly after birth low birth weight and preterm birth malformation central nervous system injury

Informed Choice and Distant Harms

Virtually Universal Disclosure Essential
Average parity is low and many women do not intend to be pregnant again, but many change their minds many decide to continue with unintended pregnancies primary cesarean rate is rising access to VBAC is declining

Special concern for high-parity populations

Disclosure essential unless a woman cannot become pregnant in future (e.g., having tubal ligation)

Are Planned Cesareans (Before Labor) the Answer?

Some advantages relative to unplanned cesareans:
less short-term surgical injury less emotional toll

Are Planned Cesareans (Before Labor) the Answer? (cont)

Planned cesarean is still major surgery
excess short-term surgical harms relative to vaginal birth

conditions associated with scarring and adhesions (these harms likely to be similar to unplanned cesareans)
all future fertility and pregnancy risks associated with uterine scar (these harms likely to be similar to unplanned cesarean) potential for iatrogenic respiratory problems in babies

Harms of Assisted Vaginal Birth to Mothers

In comparison with spontaneous vaginal birth, increased harms due to:
3rd and 4th degree perineal tears excessive bleeding and transfusion rehospitalization Infection Adverse impact of midline painful perineum episiotomy co-intervention urinary incontinence appears to be substantial any bowel problems for this set of outcomes bowel incontinence

Harms of Assisted Vaginal Birth to Mothers (cont)

In comparison with spontaneous vaginal birth, increased harms due to:
poor birth experience psychological trauma (traumatic symptoms, PTSD) sexual problems (pain, frequency, satisfaction) poor overall functioning/prolonged recovery

Harms of Assisted Vaginal Birth to Mothers (cont)

To limit adverse effects of assisted delivery:
maintain assisted delivery skills avoid routine episiotomy co-intervention offer cesarean if and when clear that assisted delivery will be difficult
Excellent recent SOGC guidelines available at: sogc.medical.org/SOGCnet/sogc_docs/common/guide/library_e.shtml#obstetrics

Harms of Assisted Vaginal Birth to Babies

In comparison with spontaneous vaginal birth, increased harm due to:
brain injury brachial plexus injury

Harm of Vaginal Birth* to Babies

In comparison with cesarean, increased harm due to:
brachial plexus injury

* spontaneous or overall

Harms of Vaginal Birth* to Mothers

In comparison with cesarean, increased harms due to:
perineal pain any urinary incontinence any bowel incontinence * spontaneous or overall

Problem of Overly Broad Definitions of Incontinence

Urinary may include any or minimal incontinence, at any point (e.g., drop or 2)
Bowel may include any leaking gas, any leaking feces, or any urgency without leakage, at any point Need to focus on actual concerns and experiences of women impact on womens quality of life degree to which any problems persist after recovery period

Problem of Use of Surrogate Markers

Uncertain whether group differences in physiologic measurements have any practical meaning for womens symptoms and quality of life and, if so, the duration Inappropriate to use these studies to guide practice and policy

Problem of Co-Interventions that Contribute to Pelvic Floor Dysfunction

Practices associated with pelvic floor injury:
episiotomy instrumental delivery pushing in supine or lithotomy position forceful, directed pushing fundal pressure perineal pressure

Problem of Co-Interventions (cont)

Many women experience several with vaginal birth
Liberal or routine use is not evidence-based practice Large practice variation (e.g., 2002 episiotomy rates across NYC hospitals: 1% to 88% of vaginal births)*

Potential to reduce much harm with conservative practice style and judicious use
* www.choicesinchildbirth.org

Relationship Between Vaginal Birth and Pelvic Floor Dysfunction

We did not find a single study that attempted to minimize or control for harmful co-interventions to try to understand whether giving birth through the vagina increases risk of pelvic floor problems
Inappropriate at this time to state that vaginal birth causes pelvic floor dysfunction Given current knowledge imperative to improve management of vaginal birth inappropriate to promote cesarean as preventive measure

Relationship Between Vaginal Birth and Pelvic Floor Dysfunction (cont)

We must do a better job:
Understanding the scope of problems Understanding causes of problems maternity factors (which ones?) non-maternity factors (modifiable?) Reducing risk through improvements in vaginal birth management practices Understanding and applying non-invasive prevention and treatment strategies (e.g., Kegels)

Incontinence Results with Usual Care

Incontinence after vaginal birth:
infrequent for most who experience it minimal to mild severity for most falls off sharply during recovery period

A year after vaginal birth:

about 3% have any new-onset urinary incontinence about 3% have any new-onset anal incontinence severe and troubling problems rare severe urinary or anal incontinence due primarily to combined forceps with episiotomy

Incontinence Results with Usual Care: Longer Term

Vaginal Birth and Later-life Incontinence?
incontinence problems arising at birth diminish over time differences between cesarean and vaginal groups for urinary & bowel incontinence disappear by about age 50

high rates of later-life incontinence associated with other factors

Non-Maternity Factors Associated with Incontinence

Excess weight Smoking HRT Hysterectomy Urinary tract infections Some chronic diseases Some medications Impaired mobility Genetics Many impact large numbers of women Many are modifiable

Life Course Perspective

Need to sort timing of onset of notable problems: before pregnancy during pregnancy after postpartum period Vaginal birth cannot cause, cesarean cannot prevent Increasingly common popular and professional presumption that vaginal birth is associated with any pelvic floor dysfunction: flawed

Practice Variation: Price for Lower Intervention Rates?

Over 25 studies examined practice variation for rates of:
cesarean section instrumental vaginal birth episiotomy

No evidence of adverse effects in mothers and babies with conservative care But challenging to fully account for possible differences in risk

Review Conclusion: Safest Way to Give Birth

Without clear, compelling and well-supported justification for cesarean section or assisted vaginal birth, a spontaneous vaginal birth minimizing use of interventions that may be injurious to mothers and babies is the safest way for women to give birth and babies to be born.

Myth and Reality

Myth:
Cesarean section is safe

Reality:
Vaginal birth is far safer overall for mothers and babies Although cesarean section is safer than in the past, it is major abdominal surgery and poses many extra harms for mothers and babies in comparison with vaginal birth

Myth and Reality (cont)

Myth:
Planned cesarean is on optimal solution for mothers and babies

Reality:
Vaginal birth is far safer overall for mothers and babies Planned cesarean is very convenient for busy hospitals and caregivers

Myth and Reality (cont)

Myth:
Vaginal birth is harmful for mothers and babies

Reality:
Vaginal birth is far safer overall for mothers and babies than cesarean section Some overused medical practices during vaginal birth are harmful to mothers and babies Research has not been done to determine whether giving birth through the vagina has intrinsic risks in comparison with cesarean section

Myth and Reality (cont)

Myth:
Having an elective cesarean section will prevent incontinence later in life

Reality:
Current research suggests that having a cesarean section will have no effect on incontinence later in life
Having an elective cesarean section poses many harms and limited benefit to mothers and babies

Evidence Into Education, Advocacy: Tips for Reducing Risk

Overall Tips: Pregnancy
Find doctor or midwife with low rates of intervention Discuss goals & preferences with caregiver Choose birth setting with low rates of intervention Create your own birth statement Arrange for continuous labor support Explore options for pain relief

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Overall Tips: Labor Work with caregivers to delay going to hospital Receive good support throughout labor If possible, avoid continuous EFM Avoid epidural analgesia

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Cesareans: Pregnancy If cesarean proposed, make informed decision If had previous cesarean, make informed decision If baby is breech, make informed decision If you fear vaginal birth, consider in-depth counseling

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Cesareans: Labor Avoid routine interventions when possible (in addition to EFM, epidural: induction, AROM, arbitrary time limits) If a cesarean is proposed, make informed decision

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Assisted Birth: Labor

Push in an upright or side-lying position Avoid time limits for pushing Let your body guide pushing, when possible

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Pelvic Floor Injury: Pregnancy

Talk with caregivers about avoiding routine use of interventions that can increase risk Carry out pelvic floor muscle exercises

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Pelvic Floor Injury: 1. Labor

Avoid routine use of interventions while pushing

2. After Birth

Continue pelvic floor muscle exercises

Evidence Into Education, Advocacy: Tips for Reducing Risk (cont)

Tips for Avoiding Unnecessary Pelvic Floor Injury: Throughout Life

Maintain healthy body weight Avoid smoking Continue pelvic floor muscle exercises Minimize repeated urinary tract infections Avoid hysterectomy, when possible Avoid HRT, when possible

Evidence Into Education, Advocacy: Cesarean Booklet

What Every Pregnant Woman Needs to Know About Cesarean Section
Guided by recent literature on
information needs of childbearing women risk communication, decision aids (e.g., BMJ 9/27/03) evidence-based risk reduction

Many partners provided

extensive feedback on drafts to strengthen quality eventual endorsement

Evidence Into Education, Advocacy: Cesarean Booklet (cont)

Main body:
background informed consent/informed refusal review results in brief main indications tips for reducing risk

Appendix:
details of outcomes that differ by mode of delivery absolute risk difference

Evidence Into Education, Advocacy: Resources for Pregnant Women

Printed booklet + summary insert (for purchase, bulk rates) Booklet PDF file (no charge)
www.maternitywise.org/mw/topics/cesarean/cesareanbooklet

In-depth online Maternity Topics What should I know about cesarean section? Should I choose VBAC or repeat c-section? How can I prevent pelvic floor problems when giving birth?
www.maternitywise.org/mw/topics/

Evidence Into Education, Advocacy: Media Outreach

Media briefing at New York Academy of Medicine to release results of review and booklet Press release and outreach
www.maternitywise.org/mw/topics/cesarean/cesareanbooklet

Matte release

Print PSAs for partners journals, newsletters

Evidence Into Education, Advocacy: Professional Outreach

Presentations, often by clinical partners and with booklet distribution to all registrants

Booklets/flyers at conference exhibits

Core review documents available online as PDFs
available at www.maternitywise.org/prof/cesarean/

Evidence Into Education, Advocacy: Professional Outreach (cont)

PDF summary of review results
available at www.maternitywise.org/prof/cesarean/

Manuscripts in preparation
CME resources anticipated

Evidence Into Education, Advocacy: Consultations, Adaptations

Policy and guidelines development
Adaptation for Kaiser Permanente/Northern California Adaptation for Canada (English, French), Canadian Womens Health Network

Spanish
Lower Literacy

Moving Forward: AHRQ Update

MCA participated in Evidence-based Womens Health Stakeholder meeting, encouraged fully resourced federal review comparing cesarean/vaginal harms
MCA submitted invited overview of key issues AHRQ subsequently decided to limit scope of question to planned no-indication cesarean requested by women

Federal agencies have identified parameters for review; Evidence-Based Practice Center is carrying it out

Moving Forward: Randomized Controlled Trials?

Various Calls Throughout World: RCT(s) to Assess Cesarean Without Medical Indication It will require a randomized, controlled, prospective study to clearly define the benefits of elective prophylactic cesarean delivery versus trial of labor. As the evidence suggesting superior outcomes from elective prophylactic cesarean delivery continues to mount, the time has come for a controlled multicenter clinical trial to deny or confirm the benefit of elective prophylactic cesarean delivery.
ACOG Clinical Review 2005 editorial: Ralph W. Hale, W. Benson Harer, Jr.

Moving Forward: Randomized Controlled Trials?

Not Ethical
Trials justified with equipoise and adequate informed consent Assertions of equipoise based on selective attention to just a few outcomes Skewed results strongly favoring vaginal birth render trials unethical

Would women be willing to enroll with truly informed consent?

Cannot (and will not) wait 20-25 years for results

Moving Forward: RCT Not Information Panacea

Under-represent Harms of Cesarean Follow-up expensive and challenging, especially far into future Need VERY large enrollment to measure rare, often lifethreatening outcomes (avoid type II errors) Need MANY more to measure differences when women randomized to vaginal birth violate protocol and have cesareans Even if funding, high enrollment, good follow-up occurred: full results not available for 20-25 years, while 125 million+ babies born globally every year

Moving Forward: RCT Not Information Panacea

Over-represent Harms of Vaginal Birth Harms of vaginal birth management practices would be assigned to vaginal birth Urogynecologic measurement standards exaggerate harms: measuring during rather than after recovery period (more likely with RCT) relying on surrogate markers relying on liberal definitions of incontinence without regard to womens experiences, quality of life

Moving Forward: RCTs on This Topic will Profoundly Distort Results

Under-represent harms of cesarean (inability to measure many serious outcomes or inability to detect differences)
Over-represent harms of vaginal birth (measurement issues: co-interventions, definitions, timing, surrogate measures) Measure well only small proportion of harms that differ Would erroneously confirm assertion of equipoise when balance sheet in fact strongly favors vaginal birth Beware of calls to settle matter through single RCT

Priority RCT: How Can We Improve Vaginal Birth?

Need large well-funded and -executed trial comparing usual care vaginal birth physiologic vaginal birth

With appropriate sample sizes, definitions, follow-up period, etc.

Outcomes of interest include: mode of delivery, intrapartum interventions, and outcomes that differed in MCA review and could be measured well

Moving Forward: DES Tragedy Revisited?

Belief that DES offered benefits, had no serious downsides has led to catastrophic outcomes many years later Is this being repeated with casual and liberal use of cesarean and effects of scarring, adhesions and compromised placentation?

Presentation Bibliography
Full bibliography available at:
www.maternitywise.org/mw/topics/cesarean/booklet.html

See Methods and Sources PDF

Moving Forward
We welcome the opportunity to collaborate with others to promote evidence-based maternity care.

Maureen P. Corry, MPH Executive Director

Carol Sakala, PhD, MSPH Director of Programs

corry@maternitywise.org 212 777-5000, x 4

sakala@maternitywise.org 212 777-5000, x 5