Hartmann K, Viswanathan M, Palmieri R, Gartlehner G, Thorp J, Lohr KN. Outcomes of Routine EpisiotomyA Systematic Review. JAMA. 2005;293(17):2141-2148. doi:10.1001/jama.293.17.2141
Clinical Review Section Editor: Michael S.
Lauer, MD. We encourage authors to submit papers for consideration as a “Clinical
Review.” Please contact Michael S. Lauer, MD, at firstname.lastname@example.org.
Author Affiliations: Center for Women’s
Health Research (Drs Hartmann and Thorp and Ms Palmieri), Department of Epidemiology,
School of Public Health (Dr Hartmann and Ms Palmieri), Department of Obstetrics
and Gynecology, School of Medicine (Drs Hartmann and Thorp), and Cecil G.
Sheps Center for Health Services Research (Drs Hartmann and Gartlehner), University
of North Carolina at Chapel Hill; Research Triangle Institute, Research Triangle
Park, NC (Drs Viswanathan and Lohr).
Context Episiotomy at the time of vaginal birth is common. Practice patterns
vary widely, as do professional opinions about maternal risks and benefits
associated with routine use.
Objective To systematically review the best evidence available about maternal
outcomes of routine vs restrictive use of episiotomy.
Evidence Acquisition We searched MEDLINE, Cumulative Index to Nursing and Allied Health Literature,
and Cochrane Collaboration resources and performed a hand search for English-language
articles from 1950 to 2004. We included randomized controlled trials of routine
episiotomy or type of episiotomy that assessed outcomes in the first 3 postpartum
months, along with trials and prospective studies that assessed longer-term
outcomes. Twenty-six of 986 screened articles provided relevant data. We entered
data into abstraction forms and conducted a second review for accuracy. Each
article was also scored for research quality.
Evidence Synthesis Fair to good evidence from clinical trials suggests that immediate maternal
outcomes of routine episiotomy, including severity of perineal laceration,
pain, and pain medication use, are not better than those with restrictive
use. Evidence is insufficient to provide guidance on choice of midline vs
mediolateral episiotomy. Evidence regarding long-term sequelae is fair to
poor. Incontinence and pelvic floor outcomes have not been followed up into
the age range in which women are most likely to have sequelae. With this caveat,
relevant studies are consistent in demonstrating no benefit from episiotomy
for prevention of fecal and urinary incontinence or pelvic floor relaxation.
Likewise, no evidence suggests that episiotomy reduces impaired sexual function—pain
with intercourse was more common among women with episiotomy.
Conclusions Evidence does not support maternal benefits traditionally ascribed to
routine episiotomy. In fact, outcomes with episiotomy can be considered worse
since some proportion of women who would have had lesser injury instead had
a surgical incision.
Episiotomy is among the most common surgical procedures experienced
by women in the United States.1 Thirty percent
to 35% of vaginal births include episiotomy.2,3 Episiotomy
became routine practice well before emphasis on using outcomes research to
inform practice. In seeking to establish an evidence base to support or refute
the use of episiotomy, randomized clinical trials in the mid and late 1980s
found that routine episiotomy compared with restrictive use was associated
with higher risk of anal sphincter and rectal injuries and precluded a woman
from giving birth with an intact or minimally damaged perineum.4- 7 Larger
trials in more varied populations followed in the 1990s, with similar results.
Investigators also began to assess longer-term outcomes such as persistent
pain, pelvic floor defects, urinary and rectal continence, and sexual function
Despite decades of research, which many interpret as definitive evidence
against routine use of episiotomy, little professional consensus has developed
about the appropriateness of routine use. Lack of consensus is illustrated
by variation in use. At 18 Philadelphia hospitals studied in the mid 1990s,
42% of women overall had an episiotomy, while hospital averages ranged from
20% to 73%.8 From 1987 to 1992, Low and colleagues9 documented clinician-level variation from 13.3% to
84.6%, with an average of 51% among spontaneous term births in a prospectively
enrolled population of uncomplicated births. Wide variation existed among
both midwives and physicians. Variation has also been reported by time of
day10 and by facility type, size, and location.11 Obstetric health care practitioners who view episiotomy
favorably endorse survey items that state that episiotomy should be used to
“prevent perineal trauma and to prevent pelvic floor relaxation and
the consequences of pelvic floor relaxation, such as bladder prolapse and
urinary incontinence.” Furthermore, they agree with the statement that
they “prefer to employ episiotomy frequently because it is easier to
repair than the laceration that results when episiotomy is not used.”12 Simultaneous belief in prevention of future sequelae
and ease of repair creates potential for misattributed motivations.
National data on use of episiotomy show a consistent decline over the
prior 2 decades.1,2 However, persistent
wide practice variation suggests that episiotomy use is heavily driven by
local professional norms, experiences in training, and individual practitioner
preference rather than variation in the needs of individual women at the time
of vaginal birth. Our goal was to refocus attention on routine episiotomy
by systematically reviewing the best evidence available about the maternal
outcomes of routine vs restrictive use of episiotomy, including type of episiotomy.
Specifically, we sought to describe maternal outcomes such as degree of perineal
injury and pain close to the time of birth, as well as longer-term outcomes
such as urinary and fecal incontinence, pelvic floor defects, and sexual dysfunction.
We sought studies that (1) reported outcomes related to episiotomy and
perineal injury at the time of vaginal birth; (2) were published in English;
(3) had more than 40 participants; and (4) reported original research.13 For summary of short-term maternal outcomes of routine
vs restrictive use of episiotomy or of episiotomy type, we limited searches
to randomized clinical trials. For longer-term outcomes, such as incontinence,
pelvic floor defects, and sexual function, we included both trials and prospective
In collaboration with a research librarian, we searched MEDLINE, Cochrane
Collaboration resources, and the Cumulative Index to Nursing and Allied Health
Literature using the search terms episiotomy and labor stage, second. We then hand-searched reference lists
of research articles, reviews, and texts and consulted with our advisory group
to ensure full identification of relevant articles from 1950 through May 2004.
We conducted dual independent reviews of abstracts and a single review of
full articles to apply the inclusion criteria. Initial data abstraction was
done by K.H., M.V., R.P., G.G., and J.T. and a second team member assessed
initial entries for accuracy, completeness, and consistency. The 2 abstractors,
with the full team as needed, reconciled discrepancies.
To rate quality of individual articles, 2 authors independently rated
each article. A third author reviewed scores and flagged differences. We reconciled
any differences in component or overall quality classification by consensus.
To grade the global strength of evidence relevant to specific outcomes, we
used the approach described by West and colleagues.14 That
system encompasses 3 domains: (1) quality of the individual studies as assessed
by examination of a checklist of specific elements of study design and conduct;
(2) quantity of relevant studies identified (including number of studies and
adequacy of the sample size); and (3) consistency of findings. Grades for
strength of evidence were assigned by consensus.13
Although meta-analysis was not the primary goal, we calculated summary
measures when possible. Variation between studies was assessed using tests
of homogeneity, including exact tests as required. Scarcity of studies with
similar exposure categories, outcome measures, and timing of measurement often
prohibited calculation of summary measures and examination of sources of heterogeneity.
For summary estimates, we required similar measures in the same time frame.
When heterogeneity was observed (P<.10), we used
DerSimonian and Laird random-effects models to generate summary measures.15 If no meaningful heterogeneity was found, we applied
Mantel-Haenszel fixed-effects models to estimate summary measures.
Our search identified 986 articles; 659 were excluded after reviewing
the abstract. We reviewed the full texts of 327 articles. Twenty-six met inclusion
Seven randomized trials, with a total of 5001 participants, compared
restrictive vs routine use of episiotomy.16- 22 Six
of the 7 trials used mediolateral episiotomy. The only North American trial,
conducted in Canada, used midline episiotomy, which is more conventional in
the United States.19 Each trial compared 2
groups: a group in which the obstetric health care practitioner was to restrict
use of episiotomy and a group with a liberal use policy that endorsed routine
use. The strictest definition of restrictive use was to avoid episiotomy unless
indicated for fetal well-being.16,22 Other
definitions pivoted on instructions to “avoid episiotomy,” use
only when “medically necessary,” or not perform episiotomy for
the purpose of avoiding a laceration.17- 19,21 The
largest trial defined restrictive use as only for fetal indications or to
avoid severe lacerations.20 Routine use groups
were defined in terms such as “routinely conducted,” “usual
care,” and “elective.”17- 21 Two
studies described routine as use to preempt a tear.16,22
Overall, inclusion criteria for these studies were poorly specified.
Generally, participants had term births of singletons with vertex presentation.
Three studies enrolled only women having a first birth, which eliminates influence
of prior perineal trauma on trial outcomes.17,21,22 In
studies without parity restrictions, the proportion of women who were primiparous
ranged from 40% to 68%, with good balance between study groups.16,18- 20 In
1 exception, multiparous women were somewhat more likely to be in the restrictive
Each study focused on normal spontaneous vaginal births. To reduce the
number of operative vaginal deliveries or cesarean births, most trials allocated
women as close to birth as feasible. The proportion of assisted vaginal births
ranged from 0 to 5%16,19- 21 up
to 15%.17,18,22 In
2 cases, authors noted the number of cesarean births and exclusion from further
analyses.19,22 Both of these studies
enrolled women during prenatal care, an approach that improved representativeness
of the population, making exclusion from analysis logical.
Perineal Outcomes. Quiz Ref IDThe strongest
trial (good quality) was the first conducted,16 which
achieved a wide gradient of episiotomy use: 10.2% in the restrictive use group
and 51.4% in the routine use group. Women in the restrictive use group were
more likely to have an intact perineum; 33.9% in the restrictive use group
had neither posterior perineal lacerations nor episiotomy compared with 24.3%
in the routine use group. Third- and fourth-degree lacerations were
rare (0.5% overall) and did not differ by group. Among nulliparous women,
74% of the restrictive use group compared with 89% of the routine use group
required any suturing, including for anterior or labial lacerations. For multiparous
women, 66% of the restrictive use group and 69% of the routine use group required
The largest trial was a multisite Argentine study of fair quality, with
2606 participants.20 This study documented
decreased risk of posterior perineal surgical repair (relative risk [RR],
0.72; 95% confidence interval [CI], 0.68-0.75) and a 2.4-fold increase in
risk of anterior tears among women in the restrictive use group (95% CI, 1.89-2.94)
compared with routine use. Sixty-three percent of women in the restrictive
use group had a surgical repair compared with 88% in the routine use group.
Pain and healing complications were less frequent in the restrictive use group.
Results of the remaining trials were compatible with these findings
(Table 1): intact perineum was uniformly
less common in the routine compared with the restrictive use group (RR, 0.46;
95% CI, 0.30-0.70).16,18,19,21,22 With
2 exceptions,16,19 studies reported
more third- and fourth-degree lacerations in the routine use group. All trials
were underpowered to distinguish differences, with a total of 105 rectal injuries
among 5001 participants (RR for routine vs restrictive use, 1.13; 95% CI,
0.78-1.65).16- 22 Anterior
lacerations, including anterior labial lacerations, were more common in the
restrictive use groups in 4 studies16,19,20,22 and
in the routine use group in 1 study.21 Anterior
lacerations did not contribute to overall higher use of suturing, suggesting
that these tears were less severe than posterior tears. Need for any suturing
was 26% higher in the routine use groups (RR, 1.26; 95% CI, 1.08-1.48).16,20,21
Pain Outcomes. Five studies assessed pain outcomes
(Table 2).16,18- 20,22 Sleep
and colleagues used midwives masked to group to assess pain at 10 postpartum
days.16 Participants reported their pain severity
in the prior 24 hours. Severity was virtually identical between groups: in
the routine use group, 14.6% had mild pain, 7.8% had moderate pain, and 0.2%
had severe pain; respective proportions for the restrictive use group were
14.1%, 7.5%, and 0.9%. Use of oral analgesics by postpartum day 10 was rare
and comparable at 2% and 3%, respectively. Pain outcomes were also comparable
at 3 months.
House and colleagues reported that level of pain was more severe on
the third postpartum day in the routine use group.18 They
assessed pain using a visual analog scale during an interview conducted by
an author (masking was not noted). On day 3 in the routine use group, 11%
had severe pain, 34% had moderate pain, and 55% had mild pain; respective
categories for the restrictive use group were 10%, 22%, and 68%. The restrictive
use group had less tenderness on examination on the third postpartum day:
79% had mild or minimal pain, 18% had moderate pain, and 3% had severe pain
compared with 51%, 39%, and 10% in the routine use group, respectively. These
differences were statistically significant and likely to be clinically relevant.
Differences in pain by group were resolved by 6 weeks and 3 months.
The only trial using midline episiotomy found no difference in McGill
Pain Scale scores for perineal pain or pain with urination on days 1, 2, and
10.19 The Argentine study20 did
not adequately define how they measured pain and reported “pain on the
day of discharge.” The routine use group was described as 42.5% with
pain and the restrictive use group as 30.7% with pain.
The most recent study provided the most nuanced approach to pain assessment.22 The investigators used a 100-mm visual analog scale
to assess pain with 4 activities. During bed rest, women in the routine use
group reported mean scores of 39 mm (SD, 28 mm) compared with 22 mm (SD, 21
mm) in the restrictive use group; during sitting, 69 mm (SD, 23 mm) compared
with 51 mm (SD, 25 mm); during walking, 56 mm (SD, 24 mm) vs 37 mm (SD, 24
mm); and during defecation, 36 mm (SD, 30 mm) vs 21 mm (SD, 21 mm). Across
all activities the restrictive use group experienced less perineal pain (P = .005-.048), with differences likely to be
Quiz Ref IDNone of the 5 studies found pain to be lessened by
routine episiotomy. No summary measures were appropriate given the variety
of methods and timing of pain measurement.
Healing Outcomes. Two trials reported physical
examinations. The Argentine trial reported no differences in hematoma prior
to discharge and, at 7 days, infection, healing complications, or dehiscence.
Only 44% of the women were evaluated at 7 postpartum days.20 House
and colleagues18 examined participants at 3
days and at 6 weeks. Risk of infection was assessed for all participants on
day 3. Poor wound apposition and granulation tissue, indicating secondary
healing, were assessed at the later visit, which included 53% of participants.
Each adverse outcome was equivalent.
Other Outcomes. Two studies estimated maternal
blood loss. One found no difference in change in maternal hemoglobin.22 The other found that estimated blood loss (method
not defined) was 58 mL greater in the routine use group, a statistically but
not clinically relevant difference.18
Only 1 trial and no prospective cohorts compared midline and mediolateral
episiotomy.23 The trial allocated women having
a first birth to midline episiotomy (“incisions divided 2 cm to 3 cm
of the perineal tissue in the midline”) or mediolateral incisions (“made
from the midline and carried to the right of the anal sphincter for about
3 cm to 4 cm”).23 This study received
a poor quality rating. We noted an inadequate randomization method, lack of
allocation concealment, and failure to mask outcome assessors as potential
sources of bias.
More complications occurred in the midline group (P<.001). Twenty-four percent of the midline group had an extension
of the episiotomy into or through the sphincter compared with 9% of the mediolateral
group. The midline group had less bruising of the perineum (P<.001). The investigators did not find differences in pain. Of
participants, 76% attended 3-month follow-up. Women in the midline group began
sexual intercourse earlier (P<.01) and had a better
cosmetic appearance of the scar (P<.02) than the
mediolateral group. No differences in pain or satisfaction from sexual intercourse
Sixteen publications prospectively collected data about continence or
pelvic floor muscle function (Table 3).
These publications include 4 reports from 2 trials of restrictive vs routine
12 additional prospective cohorts.26- 37
Quiz Ref IDNeither trial found meaningful differences in measures
of urinary incontinence, including perineometry, and self-report of involuntary
loss of urine, use of a pad, and loss of urine with coughing, sneezing, and
laughing at 3 months16,19 or 3
years.24 Among prospective studies,
Sartore and colleagues29 conducted the most
global assessment of continence and pelvic floor function. At 3 months, women
who had episiotomy had reduced pelvic floor muscle strength as assessed by
perineometry compared with women with spontaneous tears. The clinical significance
of this finding is unclear because all self-reported symptoms of urinary and
anal incontinence and degree of prolapse on physical examination were equivalent.
In addition to trials, 6 studies (5 study populations) evaluated self-reports
of urinary continence.26- 29,32,33 Episiotomy
and spontaneous-tear groups had the same frequency of incontinence symptoms
(RR for trials, 1.02; 95% CI, 0.83-1.26; RR for cohorts, 0.88; 95% CI, 0.72-1.07).16,19,27- 29 No
evidence supports episiotomy to prevent pelvic floor damage. Four cohort studies
asked women about rectal incontinence, including 1 that also conducted physical
examinations.29- 31,34 None
found episiotomy to be statistically associated with reduced risk of incontinence
of stool or flatus. Indeed, in aggregate the 2 studies with comparable measures
suggest an almost 2-fold increase in risk (RR, 1.91; 95% CI, 1.03-3.56).29,31
Five studies included physiologic measures of pelvic floor muscle function.
None found an advantage for episiotomy25,35- 37 and
1 identified a decrease in muscle strength.29 These
muscle function measures concur with self-report and clinical examination
findings of other studies. Episiotomy confers no benefits with respect to
preserving continence or pelvic floor muscle function within months or years
of birth. Longer-term data are absent.
Nine studies (10 publications) prospectively collected data about sexual
function: 3 trials of restrictive vs routine use of episiotomy,16,19,24 1
trial of mediolateral vs midline episiotomy,23 and
5 prospective cohorts.25,27,29,38,39 One
study described by the authors as retrospective included a time point at 6
months with current rather than recalled data about sexual function.40
Two trials of restrictive vs routine episiotomy reported intention-to-treat
analyses of long-term sexual outcomes (Table 4). Quiz Ref IDIn the first trial,16 37%
of the restrictive use group and 27% of the routine use group had resumed
sexual intercourse by 1 month after the birth (P<.01).
The proportions of women with resumption of intercourse by 3 months, dyspareunia
at 3 months, or any dyspareunia within 3 months did not differ by group. By
the third year of follow-up, likelihood of “ever suffering painful intercourse”
Klein and colleagues19 reported that
women in the restrictive use group resumed intercourse an average of 1 week
earlier than those in the routine use group. All measures of sexual function
were equivalent by 3 months. This team conducted a separate analysis of type
of perineal trauma and sexual function using 3-month interviews. Women with
episiotomy had the slowest return to intercourse (P = .02).
Pain with first postpartum intercourse was also most common and severe among
women with episiotomy (P<.001).25
Prospective cohort studies did not find differences in sexual function
(Table 4). Only 1 study identified differences
in dyspareunia at 3 months.29 However, pooled
estimates of prevalence at 3 months can be estimated from 2 cohorts.29,38 The summary estimate suggests that
women with episiotomy tend to be more likely to report pain with intercourse
3 months after delivery (RR, 1.53; 95% CI, 0.93-2.51).29,38 The
2 studies that assessed any dyspareunia during the first 3 months after childbirth
also found no difference in probability of having had painful intercourse.
Our systematic review finds no benefits from episiotomy. We identified
fair to good evidence suggesting that immediate outcomes following routine
use of episiotomy are no better than those of restrictive use. Indeed, routine
use is harmful to the degree that some proportion of women who would have
had lesser injury instead had a surgical incision.
Weak evidence from a single trial suggests that harms of midline episiotomy
are greater than mediolateral episiotomy due to greater risk of rectal injury.
Multiple retrospective cohort studies also document higher sphincter injury
rates with midline episiotomy.41- 47 Health
care practitioners attending births in the United States are likely to have
greater experience performing midline than mediolateral episiotomy. We caution
against a shift to an unfamiliar technique; suggesting more restrictive use
of episiotomy will avert a larger number of all types of perineal injuries
than change in technique.
The overall level of evidence on long-term sequelae—specifically,
fecal and urinary incontinence, pelvic floor function, and future sexual function—is
fair to poor. With regard to incontinence, the research is consistent in demonstrating
lack of benefit in a comparatively early time frame. Quiz Ref IDFor
women in later adult life, when morbidity is most likely to occur as severe
and persistent incontinence or pelvic organ prolapse, the expected results
of routine episiotomy are unknown. No evidence suggests that sexual
function is improved by episiotomy; those who have episiotomy may be more
likely to have pain with intercourse in the months after pregnancy and are
slower to resume having intercourse.
While trials with strong definitions restricting use to fetal indications
have achieved use as low as 8% to 10% (along with high proportions of births
with an intact perineum),16,17 in
contemporary practice episiotomy use remains more than 3-fold higher. In the
absence of benefit and with a potential for harm, a procedure should be abandoned.
The majority of the data we have reviewed have been available for decades
and thoughtfully reviewed by others. As in many discretionary procedures,
practice patterns have been slow to change. However, in this instance, clinicians
have been the primary agents to exercise choice to conduct or not conduct
an episiotomy, rather than patients.
The time has come to take on the professional responsibility of setting
and achieving goals for reducing episiotomy use. Much as surgical specialists
have reduced use of procedures like knee surgery for arthritis and tonsillectomy
in children, clinicians must attend to aligning research evidence and episiotomy
use. Rates of episiotomy of less than 15% of spontaneous vaginal births should
be immediately within reach. Clinicians need to work within hospitals, practices,
and birthing centers to better track the prevalence of circumstances that
likely warrant use, such as fetal distress, to refine target rates that fit
the characteristics and labor experiences of the populations. In doing so,
clinicians must acknowledge that little, if any, evidence is available to
define indications for use; however, it is clear that maternal benefit is
not an indication. Investigators need to study barriers to decreased use,
including the influence of case-mix on use, and to investigate approaches
to promoting change in clinician behavior. As episiotomy is used less, opportunities
will be gained to better study other techniques intended to prevent or reduce
perineal injury. The goals for quality of care must remain focused on both
optimizing safety for the infant and minimizing harm to the mother. Given
that focus, clinicians have the opportunity to forestall approximately 1 million
episiotomies each year that are not improving outcomes for mothers.
Corresponding Author: Katherine Hartmann,
MD, PhD, Center for Women’s Health Research, University of North Carolina,
Campus Box 7521, 725 Airport Rd, Chapel Hill, NC 27599-7521 (email@example.com).
Financial Disclosures: None reported.
Funding/Support: This review was supported
by contract 290-02-0016 from the Agency for Healthcare Research and Quality
(AHRQ), Task No. 4.
Role of the Sponsor/Disclaimer: This article
was developed through work conducted by the RTI International–University
of North Carolina Evidence-based Practice Center under AHRQ contract 290-97-0011.
The sponsoring agency provided advice and counsel on the design and conduct
of the evidence report on which this article is based, review of the draft
evidence report, acceptance and approval of the final evidence repot, and
review and approval of the draft manuscript of this article. The authors of
this article are solely responsible for its content, including any clinical
or treatment recommendations. No statement in this article should be construed
as an official position of the AHRQ or the US Department of Health and Human
Also Available: A more detailed systematic
evidence review of episiotomy in obstetrical care will be available at http://www.ahcpr.gov/clinic/epcix.htm.
Acknowledgment: We acknowledge the continuing
support of Kenneth Fink, MD, MGA, MPH, director of the AHRQ Evidence-Based
Practice Center (EPC) Program, and Marian James, PhD, the AHRQ task order
officer for this project. In addition, we thank the members of our technical
expert panel, who provided input and advice for the full evidence report on
which this article is based: Leah Albers, CNM, DrPH; Linda Brubaker, MD; Pierre
Buekens, MD, PhD, MPH; John O. L. DeLancey, MD; William Droegemueller, MD;
David A. Grimes, MD; and Dwight J. Rouse, MD, MSPH. The investigators deeply
appreciate the considerable support, commitment, and contributions of the
EPC team staff at Research Triangle Institute International and the University
of North Carolina (UNC), as well as the Center for Women’s Health Research
at UNC. From UNC, we thank Timothy S. Carey, MD, MPH; B. Lynn Whitener, PhD;
Leah Randolph, MA; Laura Morgan, MA, Richard MacLehose, MPH, and Anita Baldi,
BA. We also express our gratitude to Research Triangle Institute staff: Linda
Lux, MPA; Tammeka Swinson, BA; Loraine Monroe; and Debra Bost.