Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial.

OBJECTIVE: To compare the efficacy and tolerability of vaginal misoprostol and laminaria for cervical preparation before second-trimester surgical abortion. STUDY DESIGN: We performed a prospective, randomized trial comparing midnight administration of misoprostol 600 mcg vaginally to midnight placement of laminaria, before surgical abortions among women at 13-20 weeks of gestation. The primary outcome was preoperative cervical dilation. Secondary outcomes were the need for further dilation, procedure duration and difficulty, immediate complications and side effects. RESULTS: Eighty-four women were randomized, with a median gestational age of 16.5 weeks. The mean time interval between misoprostol and laminaria placement and dilatation and evacuation initiation was 11.0±2.9 and 11.2±2.0h, respectively (p=.17). Cervical dilation was not greater in the laminaria group as compared to the misoprostol group (12.8 vs. 12.4mm, respectively; p=.32). No difference was demonstrated regarding the need for additional dilation or the difficulty of the procedure. Procedures performed after laminaria insertion were 1 min longer (median 11 vs. 10 min, p=.04). Participants found laminaria placement more uncomfortable than vaginal misoprostol placement. Other than pain, additional side effects occurred only in the misoprostol group, primarily nausea and vomiting. One participant in the misoprostol group experienced fetal expulsion during the night before the intended procedure. CONCLUSION: Either vaginal misoprostol or laminaria provides adequate dilation for second-trimester surgical abortion. Laminaria causes more pain at insertion and misoprostol causes more side effects. IMPLICATIONS STATEMENT: We found that cervical preparation in an inpatient setting for approximately 11h with misoprostol 600 mcg vaginally is comparable to 11h of laminaria. However, given the potential for spontaneous expulsion and more side effects with misoprostol, laminaria is likely a better general option in such a setting.

Are enemas given before cesarean section useful? A prospective randomized controlled study.

OBJECTIVE: To assess the effect of preoperative enemas on the postoperative recovery of bowel habits in women undergoing elective cesarean section. STUDY DESIGN: A prospective randomized controlled study with a standard two-group parallel design. The study was registered at the Protocol Registration System of the National Institute of Health (NCT00391599). With an α of 0.05, and a ß of 0.1 (power of 90%) 65 participants were required in each group. The inclusion criteria were elective cesarean section and no history of previous abdominal operations except for cesarean delivery. Randomization was done by random number generator. The study group (n=65) was given a Fleet enema and the controls (n=65) had no preoperative intestinal preparation. The primary outcome measures were postoperative return of bowel sounds, gas passage and first spontaneous feces. Care givers and those assessing the outcomes were blinded to group assignment. RESULTS: On postoperative day 1, among women who had a preoperative enema, 35.3% had bowel sounds, 47.2% had gas passage and 1.5% had spontaneous feces, compared to 47.2%, 52.8%, and 10.8%, respectively, among those who had no enema. The differences were not statistically significant. CONCLUSION: As we could not demonstrate any benefit for preoperative enema, we recommend against routine use of preoperative enema prior to elective cesarean delivery.

Reduced third-trimester levels of soluble human leukocyte antigen G protein in severe preeclampsia.

OBJECTIVE: Recently, lower maternal plasma human leukocyte antigen (HLA)-G protein levels in preeclampsia (PE) in the first and second trimester was reported. Thus, we sought to evaluate the levels of HLA-G protein in patients with severe PE during the third trimester. STUDY DESIGN: In this prospective case control study, amniotic fluid and maternal and cord blood samples were aspirated from 50 pregnant women during the third trimester. The study group included 26 pregnant women diagnosed with severe PE and 24 women without PE serving as controls. A soluble HLA-G-specific enzyme-linked immunosorbent assay was used to measure protein levels. Statistical analysis included the Student t test and simple regression analysis. RESULTS: Maternal serum HLA-G levels in PE pregnancies were found to be significantly lower as compared with normal pregnancies (10.97 +/- 6.55 vs 36.05 +/- 34.53 microg/mL; P = .003). CONCLUSION: A reduced level of maternal HLA-G protein was associated with severe PE during the third trimester. This finding may suggest an essential role for HLA-G in normal and preeclamptic pregnancies.

Mode of delivery in pregnant women with hypertensive disorders and unfavorable cervix following induction of labor with vaginal application of prostaglandin E.

BACKGROUND: Our aim was to evaluate the mode of delivery in pregnant women with hypertensive disorders and unfavorable cervix following induction of labor with vaginal application of prostaglandin E(2) (PGE(2)) near or at term, and to define the predictors of successful vaginal delivery in such women. METHODS: In a retrospective case-controlled study, pregnant women with hypertension, who underwent labor induction with PGE(2) tablets (study group, n = 284), were compared with women, who underwent elective induction of labor (group 2, n = 115), and women with normal spontaneous onset of labor (group 3, n = 510). RESULTS: The rate of cesarean section (CS) was significantly higher in the study group (25.3%) than in group 2 (14.8%) and in group 3 (9%). Exclusion of the nulliparous women from the study and control groups yielded similar CS rates in the study group (16.9%) and in group 2 (11.1%). Women with pre-eclampsia and the women with chronic hypertension or pregnancy-induced hypertension had similar rates of CS. In logistic regression model, nulliparity, induction of labor with PGE(2), and maternal age, but not hypertensive disorders, were independently and significantly associated with increased risk of CS. CONCLUSIONS: PGE(2) induction of labor is successful in approximately 75% of patients with hypertensive disorders and unfavorable cervix, with apparently no serious maternal or fetal complications. The induction of labor by itself, and not the hypertensive disorders in pregnancy, is independent risk factor for CS.

Induction of labor in pregnancies with suspected large-for-gestational-age fetuses and unfavorable cervix.

OBJECTIVES: To evaluate our single-center, single-team experience with induction of labor in pregnancies with suspected large for gestational age (LGA) fetuses. STUDY DESIGN: A retrospective case-controlled design was used. Non-diabetic patients with a suspected LGA fetus (estimated fetal weight > or =90th percentile) (group 1, n = 135) were compared with healthy patients admitted for elective induction of labor for either post-date pregnancy or a subjective perception of decreased fetal movements in the presence of normal fetal heart monitoring and biophysical profile (group 2, n = 326), and with healthy women with normal pregnancies and spontaneous onset of labor (group 3, n = 574). RESULTS: There were no between-group differences in maternal age, parity, number of prostaglandin E2 (PGE2) tablets used, instrumental delivery rate or Apgar scores. The rate of cesarean section (CS) was significantly higher in the study group (33.3%) than in group 2 (17.8%, P = 0.001) and group 3 (10.6%, P = 0.004), although this difference disappeared when the multiparous women were analyzed separately (study group: n = 58, 10.3% versus group 2: n = 169, 7.7% and group 3: n = 308, 7.8%, P = 0.6). A logistic regression model (R2 = 0.385, P < 0.001) was used to control for maternal and gestational age, nulliparity rate, number of PGE2 tablets used, birth weight, and diagnosis (group 1 versus group 2) as predictors of mode of delivery. On stepwise (forward-likelihood) analysis, only nulliparity (odds ratio (OR) 10.0, 95% confidence interval (CI) 2.8-35.6, P < 0.001) and maternal age (OR 1.2, 95% CI 1.06-1.36, P = 0.002) were independently and significantly associated with increased risk of CS. CONCLUSIONS: Induction of labor for suspected LGA fetuses, if performed at all, should be reserved for multiparous women.

Mode of delivery in pregnancies with premature rupture of membranes at or before term following induction of labor with vaginal prostaglandin E2.

Our aim was to evaluate the mode of delivery in pregnancies complicated with premature rupture of the membranes (PROM) at or before term following induction of labor with vaginal application of prostaglandin E2 (PGE2), and to identify possible predictors leading to cesarean section (CS). The study sample consisted of 220 women with term-PROM who did not enter spontaneous labor after 24 hours of expectant management and 42 with preterm (P)-PROM, who underwent labor induction with vaginal PGE2. Findings were compared with 115 women admitted for elective induction of labor, and 510 women with normal spontaneous-onset labor. There were no between-group differences in gravidity, parity, nulliparity rate, or number of PGE2 tablets used. Women with P-PROM were admitted at 34.6 +/- 2.4 weeks gestation, and delivered at 36.1 +/- 1.6 weeks (mean interval, 5.0 +/- 7.9 days; range, 0.5 to 40 days). The rate of CS was different only between the term-PROM (18.6%) and spontaneous onset of labor (9%) groups (odds ratio, 2.08; 95% confidence interval, 1.4 to 3.4). The rate of low 5-minute Apgar score (< 7) was similar in all groups, but the incidence of nonreassuring fetal heart rate pattern leading to CS was significantly lower in the PROM groups. A logistic regression model and forward likelihood analysis in the PROM groups yielded parity, higher number of PGE2 tablets used, and higher birth weight as independent and significant variables associated with increased risk of CS. Using our management protocol, 36.4% and 20.4% of women with term-PROM and P-PROM, respectively, required labor induction with PGE2, which was successful in more than 80% of cases, with no apparent serious maternal or fetal complications.

Active induction management of labor for diabetic pregnancies at term; mode of delivery and fetal outcome--a single center experience.

OBJECTIVES: To evaluate the mode of delivery in diabetic pregnancies at term following induction of labor with vaginal application of prostaglandin E2 (PGE2), and to identify possible predictors of successful vaginal delivery. PATIENTS AND METHODS: The study group consisted of 105 women with diabetic pregnancies at term admitted for induction of labor; 84 (80%) had gestational diabetes (GDM) and 21 (20%) type 1 diabetes. Findings were compared with women who underwent elective induction of labor (n=115), and women with normal spontaneous onset of labor (n=510). Women with previous cesarean section (CS) were excluded from both study and control groups. RESULTS: Maternal age and gravidity were significantly higher in the study group than the control groups (age: 31.4+/-5, 28+/-5.0 and 28.1+/-4.8 years, respectively; gravidity: 3.0+/-1.9, 2.5+/-1.6, and 2.1+/-1.4, respectively; P<0.001 for both) and gestational age and nulliparity rate were significantly lower (gestational age: 38.6+/-1.1, 40.2+/-1.3 and 39.3+/-2.7 weeks, respectively; nulliparity: 34.6, 45.2, 51.6%, respectively; P<0.002 for both). There were no between-group differences in the incidence of oligohydramnios, number of PGE2 applications used, birth weight, rate of non-reassuring fetal heart rate pattern leading to CS, and rate of low 5 min Apgar score (<7). The rate of CS in the study group (18.2%) was significantly higher than in the spontaneous labor group (9%) but similar to the elective induction group (14.8%). On stepwise analysis, only nulliparity (OR 4.56, 95% CI 1.11-18.67, P=0.035) was independently and significantly associated with increased risk of CS. Within the study group (R2=0.257, P=0.002), type 1 diabetes (OR 2.4, 95% CI 1.04-5.51) was independently and significantly associated with increased risk of CS. CONCLUSION: In diabetic pregnancies, induction of labor at term with vaginal PGE2 is successful in approximately 82% of patients, but yields a significantly higher CS rate compared to uncomplicated pregnancies. Nulliparity and diagnosis of type 1 diabetes are independently and significantly associated with increased risk of CS. CONDENSATION: In diabetic pregnancies, induction of labor at term is successful in 82% of patients, but yields higher CS rates compared to uncomplicated pregnancies.

Indicated labor induction with vaginal prostaglandin E2 increases the risk of cesarean section even in multiparous women with no previous cesarean section.

AIMS: To evaluate the impact of induction of labor with vaginal tablets of prostaglandin E2 on the rate of cesarean section (CS), and to identify possible predictors of successful vaginal delivery. METHODS: 1541 consecutive women admitted for induction of labor with vaginal tablets of PGE2 were retrospectively compared with 574 consecutive women with spontaneous onset of labor. RESULTS: Maternal age, nulliparity, previous CS, gestational age, and birth weight were similar in the study and control groups. The CS rate was twofold higher in the study group (20.7% vs 10.6%). CS rates in the study and control groups were 26.9% and 12.8% for the nulliparous women, and 11.2% and 5.1% for the multiparous women with no previous CS. Neither group had major maternal or fetal complications. A logistic regression model and stepwise analysis showed that nulliparity, previous CS, maternal age, number of PGE2 applications, birth weight, and the induction of labor by itself were independent significant risk factors for increased CS rate. CONCLUSIONS: Induction of labor with vaginal PGE2 tablets results in a vaginal delivery rate of 79.3%, with apparently no serious maternal or fetal complications. Nulliparity, and previous CS are the most significant risk factors for increased CS rate. However, even after these risk factors are excluded and controlling for possible predictors for CS, PGE2 induction is independently associated with a twofold increase in CS rate, most often because of labor dystocia.

Mode of delivery in pregnancies with suspected fetal growth restriction following induction of labor with vaginal prostaglandin E2.

BACKGROUND: Many fetuses below the 10th percentile for gestational age are uncompromised. We aimed to evaluate the mode of delivery and immediate neonatal outcome in pregnancies with suspected fetal growth restriction (FGR) and normal antenatal assessment following induction of labor with vaginal application of prostaglandin E2 (PGE2). METHODS: Ninety women with suspected FGR (sonographic estimated fetal weight < 10th percentile) with normal oxytocin contraction test (OCT), biophysical profile (BPP) and reassuring fetal heart rate underwent induction of labor with vaginal application of PGE2 tablets. The findings were compared with 115 women admitted for induction of labor because of decreased fetal movement (group 2) and with 510 women with normal spontaneous onset of labor (group 3). RESULTS: There were no between-group differences in mean maternal age, gravidity, parity, nulliparity rate, number of tablets used or rate of patients receiving more than one PGE2 application. The rate of cesarean section (CS) in the study group (8.9%) was similar to the rate in groups 2 and 3 (14.8% and 9.0%, respectively). The incidence of nonreassuring fetal heart rate pattern leading to cesarean delivery was higher in the study group, but the rate of low 5-min Apgar scores (< 7) was similar in all groups. A logistic regression model and forward likelihood analysis yielded no single significant variable associated with increased risk of cesarean delivery. CONCLUSIONS: In selected cases of suspected FGR with reassuring fetal heart rate and normal OCT and BPP, induction of labor with vaginal PGE2 may yield a similar immediate fetal outcome and CS rate as in uncomplicated, induced or spontaneous deliveries.