A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery

Objective

To compare extra-abdominal repair of the uterine incision at cesarean delivery with in situ repair.

Methods

The present study was a double-blind randomized controlled trial conducted at a university hospital in Egypt during 2012–2013, and included women with an indication for cesarean delivery. Extra-abdominal repair was used in group 1 (n = 500) and in situ repair in group 2 (n = 500). The primary outcome measure was the surgery duration.

Results

Surgery duration was significantly longer in group 1 than group 2 (49.9 ± 2.3 minutes vs 39.9 ± 1.8 minutes; P < 0.001). More patients in group 1 than in group 2 had postoperative moderate-to-severe pain (165 [33.0%] vs 115 [23.0%]; P = 0.001) and needed additional postoperative analgesia (100 [20.0%] vs 50 [10.0%]; P < 0.001). Moreover, mean time to bowel movement was longer in group 1 than in group 2 (17.0 ± 2.7 hours vs 14.0 ± 1.9 hours; P < 0.001).

Conclusion

In situ uterine closure is more advantageous than extra-abdominal repair in terms of surgery duration, postoperative pain and need for additional analgesia, and return of bowel movement.ClinicalTrials.gov:NCT01723605     

Route of delivery following successful external cephalic version

Objective

To evaluate the delivery route and the indications for cesarean delivery after successful external cephalic version (ECV).

Methods

A retrospective matched case–control study was conducted at a hospital in Lisbon, Portugal, between 2002 and 2012. Each woman who underwent successful ECV (n = 44) was compared with the previous and next women who presented for labor management and who had the same parity and a singleton vertex pregnancy at term (n = 88). The outcome measures were route of delivery, indications for cesarean delivery, and incidence of nonreassuring fetal status.

Results

Attempts at ECV were successful in 62 (46%) of 134 women, and 44 women whose fetuses remained in a cephalic presentation until delivery were included in the study. The rates of intrapartum cesarean delivery and operative vaginal delivery did not differ significantly between cases and controls (intrapartum cesarean delivery, 9 [20%] vs 16 [18%], P = 0.75; operative vaginal delivery, 14 [32%] vs 19 [22%], P = 0.20). The indications for cesarean delivery after successful ECV did not differ; in both groups, cesarean delivery was mainly performed for labor arrest disorders (cases, 6 [67%] vs controls, 13 [81%]; P = 0.63).

Conclusion

Successful ECV was not associated with increased rates of intrapartum cesarean delivery or operative vaginal delivery.     

Effect of a single preoperative dose of sublingual misoprostol on intraoperative blood loss during total abdominal hysterectomy

Objective

To investigate whether use of preoperative misoprostol can reduce blood loss during total abdominal hysterectomy (TAH).

Methods

In a randomized double-blind placebo-controlled trial at a tertiary care hospital in Kolkata, India, between March 2011 and April 2012, women (n = 132) undergoing TAH with or without bilateral salpingo-oophorectomy for symptomatic myomas were randomly allocated to receive either 400 μg of misoprostol or placebo 30 minutes before surgery. The primary outcome measure was intraoperative blood loss was. The secondary outcomes were postoperative drop in hemoglobin, need for blood transfusion, and incidence of adverse effects.

Results

The 2 groups were similar with regard to demographic and clinical characteristics. There was a significant reduction of blood loss during TAH after sublingual administration of misoprostol compared with placebo before surgery (356 mL vs 435 mL; P = 0.049). The mean postoperative hemoglobin concentration was higher (10.5 g/dL vs 9.5 g/dL; P < 0.001) and the postoperative drop in hemoglobin was smaller (1.1 g/dL vs 1.9 g/dL; P = 0.004) in the misoprostol group than in the placebo group. No significant adverse effects occurred in either group.

Conclusion

The results showed that a single dose of misoprostol administered before abdominal hysterectomy resulted in a significant reduction of blood loss with minimal adverse effects.Clinical Trial Registry India (www.ctri.nic.in): CTRI/2011/091/000216.     

Sheathed versus standard speculum for visualization of the cervix

Objective

To determine whether modifying a plastic speculum with a flexible sheath would improve visualization and decrease pain during vaginal examination.

Methods

We conducted a prospective randomized controlled trial of 136 women undergoing vaginal speculum examination at an outpatient obstetrics and gynecology faculty practice. Patients underwent examination via a standardized technique with either a medium-sized plastic speculum (standard) or an identical speculum modified with a flexible polypropylene sheath (sheathed). Investigators recorded the percentage of the cervix visualized. After speculum insertion, patients recorded pain using a 10-cm visual analog scale.

Results

There were no substantial demographic differences between the standard (n = 67) and the sheathed (n = 68) groups. Investigators were able to visualize a significantly greater percentage of the cervix using the sheathed speculum compared with the standard speculum (95.1% ± 8.2% vs 78.2% ± 18.4%; P < 0.001), representing a 21.6% improvement in visualization, and were able to visualize the entire cervix in 42 (61.8%) patients when using the sheathed speculum compared with 11 (16.4%) patients undergoing standard speculum examination (P < 0.001). Patients undergoing examination with the sheathed speculum reported a nonsignificant decrease in pain scores (1.0 vs 1.2; P = 0.087).

Conclusion

A sheathed speculum significantly improves visualization of the cervix, without compromising patient comfort.ClinicalTrials.gov:NCT01670630     

Prediction of vaginal birth after one ceasarean delivery for non-progressive labor

Purpose

A model exists that predicts the probability of vaginal birth after cesarean (VBAC). That model is not stratified by indication at first cesarean. The aim of the study was to identify factors that may predict successful VBAC in patients operated for arrest of dilatation or descent at their first cesarean.

Methods

Retrospective analysis of all women with trials of labor after one cesarean (TOLAC) for non-progressive labor between November 2008 and October 2015 was performed (n = 231). A multivariate logistic regression analysis was carried out to generate a prediction model for VBAC at hospital admission for planned TOLAC.

Results

During the study period, we had 231 parturient women who chose to undergo TOLAC following one previous cesarean delivery for non-progressive labor. Successful VBAC occurred in 155 (67.0%) parturient women. A model consisting of previous successful VBAC, lower head station on decision at previous cesarean delivery, lower newborn weight at previous cesarean delivery and larger cervical effacement on admission at delivery planned for TOLAC correctly classified 75.3% of cases (R ² = 0.324, AUC 0.80, 95% CI 0.70–0.89, p < 0.001).

Conclusion

A predictive model, which incorporates four variables available at hospital admission for the planned TOLAC, has been developed that allows the determination of likelihood of successful VBAC following one cesarean delivery for non-progressive labor.

     

Rectally administered misoprostol versus intravenous oxytocin infusion during cesarean delivery to reduce intraoperative and postoperative blood loss

Objective

To compare the efficacy of rectally administered misoprostol with intravenous oxytocin infusion in preventing uterine atony and blood loss during cesarean delivery.

Methods

In this prospective, randomized, double-blind trial, 200 women undergoing cesarean delivery who did not have risk factors for postpartum hemorrhage were randomly allocated to receive either 800 µg of rectal misoprostol at the time of peritoneal incision or an intravenous infusion of oxytocin after delivery of the neonate. Primary outcome measures were estimated amount of intraoperative and postoperative (8 hours) blood loss and changes in hemoglobin levels 24 hours after delivery.

Results

A total of 96 and 94 women were analyzed in the misoprostol and oxytocin groups, respectively. Intraoperative and postoperative blood loss was significantly lower in the misoprostol group than in the oxytocin group (503 vs 592 mL, P = 0.003 and 74 vs 114 mL, P = 0.045, respectively). The incidence of shivering was higher in the misoprostol group (8.3% vs 1.1%, P = 0.018; RR 7.83; 95% confidence interval, 0.99-61.42).

Conclusion

Rectal misoprostol appears to be an effective alternative to intravenous oxytocin in preventing blood loss for routine use during cesarean delivery. Clinical Trials Registration: CTRI/2009/091/000075.     

Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor

Objective

To evaluate the efficacy of maintenance therapy with oral micronized progesterone (OMP) for prolongation of pregnancy in cases of arrested preterm labor.

Methods

Ninety women at 24–34 weeks of singleton pregnancy with intact membranes and arrested preterm labor were randomly allocated to receive OMP (n = 45) or placebo (n = 45) daily until 37 weeks or delivery, whichever was earlier. Outcome parameters were compared using Student t test, χ² test, Fisher exact test, and log-rank χ² test.

Results

OMP significantly prolonged the latency period (33.29 ± 22.16 vs 23.07 ± 15.42 days; P = 0.013). Log-rank analysis revealed a significant difference in mean time to delivery between the 2 groups (P = 0.014). There were significantly fewer preterm births (33% vs 58%; P = 0.034) and low birth weight neonates (37% vs 64%; P = 0.017), and significantly higher mean birth weight (2.44 ± 0.58 vs 2.14 ± 0.47 kg; P = 0.009) in the OMP group. Perinatal outcomes and adverse effects were similar in the 2 groups.

Conclusion

Maintenance tocolysis with OMP significantly prolonged pregnancy and decreased the number of preterm births.Clinical Trial Registry of India: CTRI/2011/10/002043.     

A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery

Objective

To assess whether chewing gum prevents postoperative ileus after laparotomy for benign gynecologic surgery.

Methods

A randomized study was conducted from December 1, 2010, to February 29, 2012. Patients scheduled to undergo laparotomy were randomly assigned to receive chewing gum or routine care after surgery. A chart review was performed to establish incidence of nausea and vomiting, use of antiemetics, cases of postoperative ileus (≥ 2 episodes of emesis of 100 mL or more, with abdominal distention and absence of bowel sounds), and time to discharge. Inpatient surveys recorded the time to specific events.

Results

A total of 109 patients were randomly assigned to receive chewing gum (n = 51) or routine postoperative care (n = 58). Fewer participants assigned to receive chewing gum than routine care experienced postoperative nausea (16 [31.4%] versus 29 [50.0%]; P = 0.049) and postoperative ileus (0 vs 5 [8.6%]; P = 0.032). There were no differences in the need for postoperative antiemetics, episodes of postoperative vomiting, readmissions, repeat surgeries, time to first hunger, time to toleration of clear liquids, time to regular diet, time to first flatus, or time to discharge.

Conclusion

Chewing gum after laparotomy for gynecologic surgery is safe and lowers the incidence of postoperative ileus and nausea.ClinicalTrials.gov:NCT01579175     

Effects of method of uterine repair on surgical outcome of cesarean delivery

Objective

To compare the rates of intraoperative and postoperative complications of uterine repair when performed in situ or extra-abdominally following cesarean delivery.

Methods

In this prospective randomized study 4925 women who underwent cesarean delivery were randomly assigned to in situ (n = 2462) or extra-abdominal (n = 2463) uterine repair (group 1 and group 2, respectively). The study compares drop in hemoglobin concentration (as a measure of intraoperative blood loss). It also compares operating time, time to return of bowel sound, and duration of hospitalization as well as rates of uterine atony, blood transfusion, intraoperative complications, additional use postoperative analgesics, endometritis, and wound infection.

Results

Uterine atony developed in 96 women (3.8%) in group 1 and 226 women (9.1%) in group 2 (P = 0.001). Moreover, the operating time and the time to return of bowel sound were shorter and the rates of both additional use of postoperative analgesics and wound infection were lower in group 1 (P = 0.001, P = 0.002, P = 0.001, and P = 0.003, respectively).

Conclusion

Fewer cases of uterine atony, a shorter operating time, a faster return of bowel function, a lesser need for postoperative analgesics, and lower rates of additional use of postoperative analgesics and wound infections suggest that in-situ uterine repair ought to be preferred to extra-abdominal uterine repair following cesarean delivery.     

Effect of continuous support during labor on duration of labor and rate of cesarean delivery

Objective

To evaluate the effect of continuous support provided by midwives during labor on the duration of the different stages of labor and the rate of cesarean delivery.

Method

A randomized trial of 100 eligible nulliparous women who had not received education classes on childbirth. In the intervention group (n = 50), continuous support during labor was provided; the control group (n = 50) did not receive continuous support.

Results

The two groups did not differ by age, employment, educational level, gestational age, economic status, and neonatal weight. Mean duration of the active phase of labor (167.9 ± 76.3 vs 247.7 ± 101 min, P < 0.001), second stage of labor (34.9 ± 25.4 vs 55.3 ± 33.7 min, P = 0.003), and the number of cesarean deliveries (4 vs 12, P = 0.026) were significantly lower in the intervention group compared with the control group. The rates of oxytocin use and Apgar scores of less than 7 at 5 minutes were similar between the two groups.

Conclusion

Continuous support provided by midwives during labor may reduce the duration of labor and the number of cesarean deliveries; this model of support should be available to all women.     

Outcome of the management of massive postpartum hemorrhage using the algorithm “HEMOSTASIS”

Objective

To evaluate whether the algorithm “HEMOSTASIS” (help; establish etiology; massage the uterus; oxytocin infusion and prostaglandins; shift to operating theater; tamponade test; apply compression sutures; systematic pelvic devascularization; interventional radiology; subtotal/total abdominal hysterectomy) was of value in the systematic management of postpartum hemorrhage (PPH).

Methods

A retrospective analysis was performed of all women who experienced massive primary PPH (blood loss > 1500 mL) in 2008 at St George's Hospital, London, UK. The success of the HEMOSTASIS mnemonic in PPH management was determined by assessing clinical outcome following adherence to the protocol.

Results

Patient notes were available for 95 (83.3%) of the 114 cases of primary PPH. Hemostasis was achieved in 63 (66.3%) women via use of additional oxytocics (“O”); 19 (20.0%) via suture of tears and 10 (10.5%) via tamponade (“T”); 1 (1.1%) via application of compression suture (“A”); 1 (1.1%) via systematic devascularization (“S”); and 1 (1.1%) via subtotal/total hysterectomy (“S”). There were no maternal deaths.

Conclusion

The decremental pattern of more complex interventions used demonstrates that the algorithm can provide a logical management pathway to reduce blood transfusions, hysterectomies, admissions to intensive care units, and maternal deaths.     

Term labor management and outcomes in treated HIV-infected women without contraindications to vaginal delivery and matched controls

Objective

To assess labor management and outcomes for treated HIV-infected pregnant women with no obstetric or virologic contraindications to vaginal delivery.

Method

A retrospective case-control study was conducted at a single center with 146 treated HIV-infected pregnant women without obstetric or virologic contraindications to vaginal delivery and 146 controls. Cases and controls were matched for parity, previous cesarean delivery, and geographic origin.

Results

The mode of delivery was similar in the 2 groups but the episiotomy rate was significantly lower among the HIV-infected women (29.6% vs 45.6%, P = 0.01), with no difference in mean birth weight, simple or complex perineal laceration rates or neonatal outcome. Postpartum morbidity was also similar for controls and HIV-infected women with a CD4⁺ cell count of 200 cells/mL or higher. However, in the study group, postpartum morbidity was higher among those whose CD4⁺ cell count was lower than this threshold (3.2% vs 22.2%, P = 0.007). No case of mother-to-child transmission of HIV occurred.

Conclusion

HIV-infected women with no contraindication to vaginal delivery seem to have the same labor outcomes as uninfected women.     

Risk factors for uterine rupture during a vaginal birth after one previous caesarean section: a case-control study

Objective

To study risk factors for uterine rupture (UR) in women with one previous caesarean section (CS) undergoing a vaginal birth after CS (VBAC).

Study design

A nested case-control study was conducted. Baseline characteristics, general obstetric history, details of the previous CS, current delivery and maternal and neonatal outcome were analysed for 41 cases with a UR and 157 controls (no rupture). Data were extracted from 21 Dutch hospitals.

Results

Labour induction was more common in cases than in controls (51% vs. 25% respectively, P = 0.001), and in case of induction therapy especially the use of prostaglandins (PGE2) was more frequent in the case group (86% vs. 46%, P = 0.014 for cases and controls respectively). Patients with UR had a significantly lower Bishop score (median: 2.0 vs. 4.0, P = 0.005) and received more augmentation of labour compared to controls (36% vs. 18%, P = 0.010). In the multivariate analysis induction with PGE2 and oxytocin, induction with PGE2 alone, and augmentation of labour were independent variables affecting the occurrence of UR (respectively OR 13.0, CI 2.3-74.2; OR 4.6, CI 1.9-11.3 and OR 2.7, CI 1.2-6.3). Forty-four percent of the ruptures can be explained by induction of labour with prostaglandins ± oxytocin.

Conclusion

Having studied baseline characteristics, general obstetric history, details of the previous CS and of the current delivery, we show that no factors other than the use of PGE2 (±oxytocin) in response to a low Bishop score, and augmentation of labour with oxytocin are associated with an increased risk for UR in women undergoing VBAC after one previous CS.     

The consequences of previous uterine scar dehiscence and cesarean delivery on subsequent births

Objective

To determine whether women with a previous uterine scar dehiscence are at increased risk of adverse perinatal outcomes in the following delivery.

Methods

A retrospective cohort study was conducted of all subsequent singleton cesarean deliveries performed at the Soroka University Medical Center, Beer-Sheva, Israel, between January 1, 1988, and December 31, 2011. Clinical and demographic characteristics, maternal obstetric complications, and fetal complications were evaluated among women with or without a previous documented uterine scar dehiscence.

Results

Of the 5635 pregnancies associated with at least two previous cesarean deliveries, 180 (3.2%) occurred among women with a previous uterine scar dehiscence. Women with this condition in a prior pregnancy were more likely than those without previous uterine scar dehiscence to experience subsequent preterm delivery (86 [47.8%] vs 1350 [24.7%]; P < 0.001), low birth weight (47 [26.1%] vs 861 [15.8%]; P < 0.001), and peripartum hysterectomy (5 [2.8%] vs 20 [0.4%]; P < 0.001). Nevertheless, previous uterine scar dehiscence did not increase the risk of uterine rupture, placenta accreta, or adverse perinatal outcomes, such as low Apgar scores at 5 minutes and perinatal mortality.

Conclusion

Uterine scar dehiscence in a previous pregnancy is a potential risk factor for preterm delivery, low birth weight, and peripartum hysterectomy in the following pregnancy.     

Estradiol valerate plus dienogest versus ethinylestradiol plus levonorgestrel for the treatment of primary dysmenorrhea

Objective

To demonstrate the superiority of estradiol valerate plus dienogest (E₂V/DNG) over ethinylestradiol plus levonorgestrel (EE/LNG) in reducing the number of days with dysmenorrheic pain among women with primary dysmenorrhea.

Methods

In a phase IIIb trial conducted at 44 centers worldwide between April 2009 and November 2010, otherwise healthy women aged 14 − 50 years requesting contraception were randomized to daily oral administration of E₂V/DNG (n = 253) or EE/LNG (n = 254) for three 28-day cycles. The primary efficacy variable was number of days with dysmenorrheic pain, the category of which (none, mild, moderate, severe) was self-assessed on a daily basis (irrespective of menstrual bleeding status) and recorded on diary cards. Notably, the women documented their pain as they experienced it before taking any (permitted) rescue medication.

Results

Overall, 217 and 209 women receiving E₂V/DNG and EE/LNG, respectively, completed the study. The mean ± SD change from baseline in number of days with dysmenorrheic pain was –4.6 ± 4.6 days and –4.2 ± 4.2 days for the E₂V/DNG and EE/LNG groups, respectively (P = 0.34).

Conclusion

Both E₂V/DNG and EE/LNG led to considerable relief of dysmenorrheic complaints among women with primary dysmenorrhea, decreasing the number of days with dysmenorrheic pain from baseline to a similar extent.ClinicalTrials.gov:NCT00909857     

Abdominal surgical incisions and perioperative morbidity among morbidly obese women undergoing cesarean delivery

Objective

To test the hypothesis that there is no difference in perioperative morbidity and the type of uterine incisions between vertical skin incisions (VSI) and low transverse skin incisions (LTSI) at the time of cesarean delivery in morbidly obese women.

Study design

Retrospective cohort study of morbidly obese women (BMI > 35 kg/m²) who underwent cesarean delivery between June 2004 and December 2006.

Results

During the study, 424 morbidly obese women underwent cesarean section. Patients with VSI were older (31.0 ± 6.2 years vs. 26.7 ± 5.8 years), heavier (48.2 ± 9.1 kg/m² vs. 41.7 ± 6.7 kg/m²), and more likely to have a classical than a low transverse uterine incision (65.9% vs. 7.3%), p < 0.001. After controlling for confounders, women with VSI did not have an increase in perioperative morbidity, but underwent more vertical uterine incisions (adjusted odds ratio = 18.49, 95% CI: 6.44, 53.07).

Conclusion

VSI and LTSI are safe in morbidly obese patients undergoing cesarean section, but there is a tendency for increased vertical uterine incisions in those who underwent VSI.     

Comparación de la efectividad de la pulsioximetría y el electrocardiograma fetal en las situaciones de riesgo de pérdida de bienestar fetal

Objective

To evaluate the effectiveness of pulse oximetry and fetal electrocardiogram in the management of labor with fetal heart rate patterns associated with a risk of loss of fetal well-being.

Subjects and methods

We performed an open, randomized, experimental trial with two groups: pulse oximetry was used in one group and the STAN® technique was used in the other. Each group included 40 women with single, term pregnancies in cephalic presentation and fetal heart rate patterns associated with a risk of loss of fetal well-being. The overall cesarean section rate, indications of risk of fetal distress, and neonatal acid-base balance were evaluated.

Results

No significant differences were found in the rate of cesarean section (47.5 vs 40%; P = .33), indications of risk of fetal distress (32.5 vs 37.5%; P = .41), or neonatal outcomes.

Conclusions

The use of pulse oximetry and STAN®21, as auxiliary methods to cardiotocographic recording, showed no superiority in reducing the cesarean section rate or improving neonatal outcomes.     

Maternal obesity and rate of cesarean delivery in Djibouti

Objective

To calculate the prevalence of maternal obesity and to determine the relation between obesity and cesarean delivery in an urban hospital in Djibouti.

Methods

In an observational cohort study, all women who had a live birth or stillbirth between October 2012 and November 2013 were considered for inclusion. Body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) was calculated throughout pregnancy, and women with a BMI of at least 30.0 were deemed to be obese. Multivariate logistic regression analyses were used to evaluate the relation between cesarean and obesity.

Results

Overall, 100 (24.8%) of 404 women were obese before 14 weeks of pregnancy, as were 112 (25.2%) of 445 before 22 weeks, and 200 (43.2%) of 463 at delivery. Obesity before 22 weeks was associated with a 127% excess risk of cesarean delivery (adjusted odds ratio 2.27; 95% CI 1.07–4.82; P = 0.032). Similar trends were found when the analyses were limited to the subgroup of women without a previous cesarean delivery or primiparae.

Conclusion

Prevalence of maternal obesity is high in Djibouti City and is related to an excess risk of cesarean delivery, even after controlling for a range of medical and socioeconomic variables.