The objective of our systematic review was to provide updated evidence-based guidance for surgical decisions during cesarean delivery (CD). We performed an English-language MEDLINE, PubMed, and COCHRANE search with the terms, cesarean section, cesarean delivery, cesarean, pregnancy, and randomized trials, plus each technical aspect of CD. Randomized control trials (RCTs) involving any aspect of CD technique from Jan. 1, 2005, to Sept. 1, 2012, were evaluated to update a previous systematic review. We also summarized Cochrane reviews, systematic reviews, and metaanalyses if they included additional RCTs since this review. We identified 73 RCTs, 10 metaanalyses and/or systematic reviews, and 12 Cochrane reviews during this time frame. Recommendations with high levels of certainty as defined by the US Preventive Services Task Force favor pre-skin incision prophylactic antibiotics, cephalad-caudad blunt uterine extension, spontaneous placental removal, surgeon preference on uterine exteriorization, single-layer uterine closure when future fertility is undesired, and suture closure of the subcutaneous tissue when thickness is 2 cm or greater and do not favor manual cervical dilation, subcutaneous drains, or supplemental oxygen for the reduction of morbidity from infection. The technical aspect of CD with high-quality, evidence-based recommendations should be adopted. Although 73 RCTs over the past 8 years is encouraging, additional well-designed, adequately powered trials on the specific technical aspects of CD are warranted.
Cesarean delivery (CD) is the most common major surgery performed and the 1.3 million women who undergo this operation per year in the United States face substantially increased risks of maternal morbidity and mortality compared with women who deliver vaginally.
Previously, Berghella et al summarized 150 randomized clinical trials (RCTs) published from 1960 to 2004 and made evidence based recommendations for each step of CD using US Preventive Services Task Force (USPSTF) definitions. Utilizing similar criteria as their review, our objective was to update and summarize the current body of literature regarding each technical step of CD.
Materials and methods
This review was modeled on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. We performed an English-language MEDLINE, PubMed, and COCHRANE database search with the terms, cesarean section, cesarean delivery, cesarean, pregnancy, and randomized trials plus each technical aspect of the operation (eg, lateral tilt, skin cleansing). Because the literature search for previous publication on this topic ended on Dec. 31, 2004, we searched from Jan. 1, 2005, to Sept. 1, 2012.
Each abstract was evaluated by 2 authors (J.D.D. and H.M.F.); all pertinent references from the manuscripts were obtained and reviewed. We included RCTs that reported clinical outcomes. Metaanalyses and Cochrane and systematic reviews were included only if there were additional RCTs performed in our 2005-2012 time frame. After review, evidence-based recommendations using terminology defined by the USPSTF ( Table 1 ) were reported as changed, unchanged, or new compared with the original manuscript. If, in the previous review, a CD technique was assigned a USPSTF grade A or B (technique is recommended) and no new studies were added during our 2005-2012 time frame, we did not change the grade assigned by Berghella et al. If, however, we deemed a new study (or studies) compelling enough (alone or in combination) to alter the grade, we did so by consensus of all the authors.
| Grade | Definition | Suggestions for practice |
|---|---|---|
| A | The USPSTF recommends the service. There is high certainty that the net benefit is substantial. | Offer or provide this service. |
| B | The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial | Offer or provide this service. |
| C | Note: The following statement is undergoing revision. Clinicians may provide this service to selected patients, depending on individual circumstances. However, for most individuals without signs or symptoms, there is likely to be only a small benefit from this service. | Offer or provide this service only if other considerations support the offering or providing the service in an individual patient. |
| D | The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. | Discourage the use of this service. |
| I | The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. | If the service is offered, patients should understand the uncertainty about the balance of benefits and harms. |
| Level of certainty | Description | |
| High | The available evidence usually includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. | |
| Moderate | The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as:
| |
| Low | The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:
| |
Results
From 5361 abstracts retrieved by our search, we identified 73 RCTs, 10 metaanalyses or systematic reviews, and 12 Cochrane reviews since Jan. 1, 2005. All technical aspects of CD with evidence-based recommendations and levels of certainty are summarized in Table 2 . Additional techniques with RCTs since the review by Berghella et al include the following items: thromboprophylaxis, preoperative vaginal cleaning, indwelling bladder catheterization, Misgav-Ladach technique, supplemental oxygen, self-retaining retractors, additional uterine atony prophylaxis measures, placental drainage, manual cervical dilation, and elective appendectomy.
| CD technical aspect (comment) | Recommendation a | Level of certainty a | References |
|---|---|---|---|
| Prophylactic antibiotics | |||
| Yes (all CD) | A | High | |
| Type (ampicillin or first-generation ceph) | A | High | |
| Administration (systemic) | A | High | |
| Multiple doses (NR) | D | High | |
| Timing (preskin incision) | A b | High b | |
| Thromboprophylaxis b | I b | Low b | |
| Lateral tilt | I | Low | |
| Skin cleansing (CHG or iodine) | I | Low | |
| Preoperative vaginal preparation (iodine) b | B b | Moderate b | |
| Supplemental oxygen (NR) b | D b | High b | |
| Indwelling bladder catheter b | |||
| None b | C b | Moderate b | |
| Immediate or 24-h removal b | C b | Moderate b | |
| Adhesive drape (NR) | D | Moderate | |
| Skin incision | |||
| Type (Pfaanenstiel or Joel-Cohen) | C | Moderate | |
| Length | I | Low | |
| Second scalpel (NR) | D | Moderate | |
| Subcutaneous incision | I | Low | |
| Fascial incision | I | Low | |
| Rectus muscle cutting (NR) | D | Moderate | |
| Dissection of fascia off rectus | I | Low | |
| Opening of peritoneum | I | Low | |
| Self-retaining retractors b | I b | Low b | |
| Bladder flap development (NR) | D | Moderate b | |
| Uterine incision | |||
| Type (transverse) | B | Moderate | |
| Stapling device (NR) | D | Moderate | |
| Expansion (blunt, cephalad-caudad b ) | A | High b | |
| Instrumental delivery | I | Low | |
| Prevention of postpartum hemorrhage | |||
| Oxytocin or placebo (oxytocin b ) | B b | High b | |
| Infusion rate (10-40 IU over 4-8 h) b | B b | High b | |
| Carbetocin or oxytocin | C | Moderate | |
| Miso plus oxytocin or oxytocin only (oxytocin) b | D b | Moderate b | |
| Oxytocin or tranexamic acid b | B b | Moderate b | |
| Placental removal | |||
| Spontaneous or manual (spontaneous) | A | High | |
| Glove change (NR) | D | Moderate | |
| Placental drainage b | I b | Moderate b | |
| Uterine exteriorization (surgeon preference b ) | C | High b | |
| Cleaning of uterus | I | Low | |
| Cervical dilation (NR) b | D b | High b | |
| Closure of uterine incision b | |||
| Undesired fertility (1-layer) b | A b | High b | |
| Desired fertility b | C | Moderate | |
| Decidua/serosa incorporation | I | Low | |
| Continuous or interrupted (continuous) | B | Moderate | |
| Elective appendectomy (NR) b | D b | Moderate b | |
| Intraabdominal irrigation | |||
| Saline (NR b ) | D b | Moderate b | |
| Peritoneal closure | C b | Moderate b | |
| Rectus muscles reapproximation | I | Low | |
| Technique of fascial closure | |||
| Running or locked (running, unlocked) | I | Low | |
| Sharp or blunt needles (blunt) b | A b | Moderate b | |
| Irrigation of subcutaneous tissue | I | Low | |
| Subcutaneous tissue b | |||
| ≥2 cm thickness b | |||
| Closure or nonclosure (closure) b | A b | High b | |
| Closure or drain (closure) b | A b | High b | |
| Closure or drain plus closure (closure only) b | A b | High b | |
| Closure of skin | |||
| Staples or subcuticular suture | C b | Moderate b |
a See Table 1 for recommendation and level of certainty definitions.
b Indicates changed or new recommendations based on this review.
Results
From 5361 abstracts retrieved by our search, we identified 73 RCTs, 10 metaanalyses or systematic reviews, and 12 Cochrane reviews since Jan. 1, 2005. All technical aspects of CD with evidence-based recommendations and levels of certainty are summarized in Table 2 . Additional techniques with RCTs since the review by Berghella et al include the following items: thromboprophylaxis, preoperative vaginal cleaning, indwelling bladder catheterization, Misgav-Ladach technique, supplemental oxygen, self-retaining retractors, additional uterine atony prophylaxis measures, placental drainage, manual cervical dilation, and elective appendectomy.
| CD technical aspect (comment) | Recommendation a | Level of certainty a | References |
|---|---|---|---|
| Prophylactic antibiotics | |||
| Yes (all CD) | A | High | |
| Type (ampicillin or first-generation ceph) | A | High | |
| Administration (systemic) | A | High | |
| Multiple doses (NR) | D | High | |
| Timing (preskin incision) | A b | High b | |
| Thromboprophylaxis b | I b | Low b | |
| Lateral tilt | I | Low | |
| Skin cleansing (CHG or iodine) | I | Low | |
| Preoperative vaginal preparation (iodine) b | B b | Moderate b | |
| Supplemental oxygen (NR) b | D b | High b | |
| Indwelling bladder catheter b | |||
| None b | C b | Moderate b | |
| Immediate or 24-h removal b | C b | Moderate b | |
| Adhesive drape (NR) | D | Moderate | |
| Skin incision | |||
| Type (Pfaanenstiel or Joel-Cohen) | C | Moderate | |
| Length | I | Low | |
| Second scalpel (NR) | D | Moderate | |
| Subcutaneous incision | I | Low | |
| Fascial incision | I | Low | |
| Rectus muscle cutting (NR) | D | Moderate | |
| Dissection of fascia off rectus | I | Low | |
| Opening of peritoneum | I | Low | |
| Self-retaining retractors b | I b | Low b | |
| Bladder flap development (NR) | D | Moderate b | |
| Uterine incision | |||
| Type (transverse) | B | Moderate | |
| Stapling device (NR) | D | Moderate | |
| Expansion (blunt, cephalad-caudad b ) | A | High b | |
| Instrumental delivery | I | Low | |
| Prevention of postpartum hemorrhage | |||
| Oxytocin or placebo (oxytocin b ) | B b | High b | |
| Infusion rate (10-40 IU over 4-8 h) b | B b | High b | |
| Carbetocin or oxytocin | C | Moderate | |
| Miso plus oxytocin or oxytocin only (oxytocin) b | D b | Moderate b | |
| Oxytocin or tranexamic acid b | B b | Moderate b | |
| Placental removal | |||
| Spontaneous or manual (spontaneous) | A | High | |
| Glove change (NR) | D | Moderate | |
| Placental drainage b | I b | Moderate b | |
| Uterine exteriorization (surgeon preference b ) | C | High b | |
| Cleaning of uterus | I | Low | |
| Cervical dilation (NR) b | D b | High b | |
| Closure of uterine incision b | |||
| Undesired fertility (1-layer) b | A b | High b | |
| Desired fertility b | C | Moderate | |
| Decidua/serosa incorporation | I | Low | |
| Continuous or interrupted (continuous) | B | Moderate | |
| Elective appendectomy (NR) b | D b | Moderate b | |
| Intraabdominal irrigation | |||
| Saline (NR b ) | D b | Moderate b | |
| Peritoneal closure | C b | Moderate b | |
| Rectus muscles reapproximation | I | Low | |
| Technique of fascial closure | |||
| Running or locked (running, unlocked) | I | Low | |
| Sharp or blunt needles (blunt) b | A b | Moderate b | |
| Irrigation of subcutaneous tissue | I | Low | |
| Subcutaneous tissue b | |||
| ≥2 cm thickness b | |||
| Closure or nonclosure (closure) b | A b | High b | |
| Closure or drain (closure) b | A b | High b | |
| Closure or drain plus closure (closure only) b | A b | High b | |
| Closure of skin | |||
| Staples or subcuticular suture | C b | Moderate b |
a See Table 1 for recommendation and level of certainty definitions.
b Indicates changed or new recommendations based on this review.
Preoperative preparation
Prophylactic antibiotics
Prophylactic antibiotic regimens comparing single-dose antibiotics with extended-spectrum coverage have been evaluated in 3 new RCTs. Specifically, randomized trials using ampicillin/sulbactam, triple antibiotic (ampicillin, gentamicin, and metronidazole), and penicillin and cephalothin did not demonstrate improved outcomes compared with standard cephalosporin prophylaxis. Thus, prophylaxis with a single dose of ampicillin or first-generation cephalosporins, such as cefazolin, should be administered in all women undergoing CD (recommendation: A; level of certainty: high; Table 1 ; unchanged).
Timing of antibiotic administration (preoperative vs after cord clamp) has been evaluated in 4 new RCTs and 1 metaanalysis. Two trials did not show a difference in maternal morbidity from infection, whereas 2 trials demonstrated a significant decrease in maternal morbidity from infection when antibiotics were given preoperatively with no increase in neonatal complications. A metaanalysis of 5 RCTs noted that preoperative administration (15-60 minutes prior to skin incision) significantly reduced the risk of postpartum endometritis (4% vs 8.8%, relative risk [RR], 0.47; 95% confidence interval [CI], 0.26–0.85) and total morbidity from infection (7.2% vs 14.3%, RR, 0.50; 95% CI, 0.33–0.78), with no significant effect on suspected neonatal sepsis (RR, 1; 95% CI, 0.70–1.42), proven sepsis (RR, 0.93; 95% CI, 0.45–1.96), or neonatal intensive care unit admissions (RR, 1.07 95% CI, 0.51–2.24). These trials support preoperative prophylactic antibiotic administration before all CDs (recommendation: A; level of certainty: high; Table 1 ; changed).
Thromboprophylaxis
Thromboprophylaxis during CD was not previously reviewed. No clinical trials using compression stockings and/or pneumatic compressions stockings have been conducted nor has there been a comparison of these modalities to heparin. Three RCTs (total n = 267) have evaluated the efficacy of unfractionated heparin or low-molecular-weight heparin. Given that the risk of CD-associated venous thromboembolism (VTE) is estimated to be 0.23%, these trials are collectively underpowered to provide recommendation guidance (recommendation I; level of certainty: low; Table 1 ; new).
Preoperative vaginal preparation
This type of surgical preparation has been evaluated in 2 RCTs and a Cochrane review. In a trial of more than 300 women undergoing nonemergent cesarean section, additional vaginal povidone-iodine scrub in addition to standard abdominal preparation resulted in a lower incidence of postcesarean endometritis (7-14.5%; adjusted odds ratio [OR], 0.44; 95% CI, 0.19–0.99) but not in postoperative fever or wound infection. Another RCT of 300 women using a composite infectious morbidity (postoperative fever, endometritis, sepsis, readmission, wound infection, or complication) as its primary outcome noted a nonstatistically significant decrease (6.5-9%; RR, 0.55; 95% CI, 0.26–1.11) in the vaginal cleansing arm. In a Cochrane review of 4 trials (n = 1198 women), vaginal preparation immediately before cesarean delivery significantly reduced the incidence of postcesarean endometritis (9.4-5.2%; RR, 0.57; 95% CI, 0.38–0.87), especially in women with ruptured membranes (15.4-1.4%; RR, 0.13; 95% CI, 0.02–0.66). Given these findings, preoperative vaginal preparation with povidone-iodine scrub should be considered prior to CD (recommendation: B; level of certainty: moderate; Table 1 ; new).
Indwelling bladder catheterization
The use or nonuse of an indwelling bladder catheterization at the time of CD was evaluated in 2 RCTs. A recent metaanalysis of these trials and 1 prospective nonrandomized control trial (NRCT) was notable for a decreased incidence of urinary tract infection in the uncatheterized group (0.5% vs 5.7%; RR, 0.08; 95% CI, 0.01–0.64 ; 0.6% vs 6.0%, RR, 0.10; 95% CI, 0.02–0.57 ) and no difference in urinary retention between groups (2 of 345 vs 0 of 345; RR, 5.00; 95% CI, 0.24–103.18 ; 2 of 344 vs 0 of 50; RR, 0.74; 95% CI, 0.04–15.18 ). Another RCT comparing immediate or 24 hour removal of an indwelling catheter found no significant differences in postoperative urinary retention and a nonsignificant lower incidence of positive urine culture 72 hours postoperatively in the immediate removal group (8.1% vs 11.2%; P = .489). Given the low incidence of bladder or ureteral injury reported in the literature (bladder 1.4 of 1000 CD and ureteric injury 0.27 of 1000 CD ), these trials were underpowered to detect a difference in these outcomes. In the one study that reported it, operative time was similar in both groups. These findings suggest not placing or early removal of indwelling bladder catheters may be considered during CD (recommendation: C; level of certainty: moderate; Table 1 ; new).
Supplemental oxygen
Supplemental oxygen for the prevention of CD morbidity from infection has been described in 2 RCTs. Both studies randomized patients to either 2 L of oxygen by nasal cannula during CD only (standard care) or 10 L of oxygen by nonrebreather mask (intervention group) during and for 2 hours after CD, and neither trial reported a reduction in morbidity from infection among groups and thus cannot be recommended (recommendation: D; level of certainty: high; Table 1 ; new).
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