Digital insertion of Foley catheter 16F versus 22F versus 28F in unripe cervix labor induction: A randomized trial.

AIM: To explore digital insertion in dorsal recumbent position of 16F, 22F, or 28F catheter bores on insertion failure, duration, and pain in unripe cervix labor induction. METHODS: A randomized trial was performed in a University hospital in Malaysia. Term women scheduled for labor induction, Bishop score ≤ 5, singleton, cephalic presentation, intact membrane, and reassuring pre-induction fetal heart rate tracing were recruited. Women with known gross fetal anomaly, allergy to latex and inability to consent or language difficulty were excluded. Participants were randomized to 16F, 22F, or 28F Foley catheter. Primary outcome was insertion failure and main secondary outcomes were insertion duration and pain (assessed by a Visual Numerical Rating Scale [VNRS] 0-10, higher score more pain). Analysis is done by analysis of variance (ANOVA), Kruskal-Wallis, and chi square test across the three arms and by t test and Mann-Whitney U test for pair wise comparisons. RESULTS: One hundred twenty-seven participants' data were analyzed. The insertion failure 7/43(16%) versus 4/42(10%) versus 5/42(12%), p = 0.64, insertion duration median [IQR] 2.8 [1.8-4.8] versus 2.8 [1.7-3.7] versus 2.8 [1.7-4.3] min, p = 0.68 and insertion pain VNRS mean {SD} 4.2 {2.5} versus 3.4 {2.3} versus 3.6 {2.2}, p = 0.26, insertion to delivery interval 26.0 {9.7} versus 25.6 {9.1} versus 22.8 {7.4} h, p = 0.45, and spontaneous vaginal delivery 20/43 (45%) versus 23/42(55%) versus 25/42(60%), p = 0.48 for 16F versus 22F versus 28F arms, respectively. Pairwise comparisons were not different. CONCLUSION: Foley catheter 16F versus 22F versus 28F resulted in similar digital insertion performance in the dorsal recumbent position for unripe cervix labor induction. CLINICAL TRIAL REGISTRATION: https://doi.org/10.1186/ISRCTN21224268.

Metformin in gestational diabetes mellitus: A double-blind placebo-controlled randomized trial.

OBJECTIVE: To evaluate the impact of preemptive metformin on the level of glycosylated hemoglobin (HbA1c) at 36 weeks of pregnancy in women with gestational diabetes mellitus controlled by diet change (GDMA1). METHODS: A randomized, double-blind, placebo-controlled trial was performed in a university hospital. Women with GDMA1 were recruited at 16-30 weeks of pregnancy and randomized to oral metformin 500 mg twice daily or identical placebo tablets to delivery. Level of HbA1c was taken at recruitment and at 36 weeks of pregnancy. The primary outcome was the change in level of HbA1c at recruitment and 36 weeks of pregnancy. RESULTS: Data from 106 participants were analyzed. The level of HbA1c during pregnancy increased significantly with a mean increase of 0.20% ± 0.31% (P < 0.001; metformin) versus 0.27% ± 0.31% (P < 0.001; placebo). An increment of 0.07% across trial arms was not significant (P = 0.310). Mean birth weight was significantly lower in the metformin group (2.81 ± 0.41 kg vs 2.98 ± 0.37 kg; P = 0.030). Rates of macrosomia (≥3.5 kg; 0/53 [0%] vs 4/53 [8%]; P = 0.123) and low birth weight (<2.5 kg; 11/53 [21%] vs 5/53 [9%]; P = 0.102) were not significantly different. CONCLUSION: Preemptive metformin did not prevent the level of HbA1c at 36 weeks of pregnancy from rising nor significantly reduce the increase of HbA1c. Mean birth weight was significantly lower in the metformin arm with a non-significant trend to low birth weight, which is concerning. ISRCTN: ISRCTN10845466.

Contemporary approaches to hyperemesis during pregnancy.

PURPOSE OF REVIEW: Nausea and vomiting of pregnancy (NVP) affects 90% of pregnant women and its impact is often underappreciated. Hyperemesis gravidarum, the most severe end of the spectrum, affects 0.5-2% of pregnancies. The pathogenesis of this condition remains obscure and its management has largely been empirical. This review aims to provide an update on advances in pregnancy hyperemesis focusing on papers published within the past 2 years. RECENT FINDINGS: The cause of hyperemesis is continuing to be elaborated. Recent data attest to the effectiveness of the oral doxylamine-pyridoxine in NVP. Follow-up data of children exposed in early pregnancy to doxylamine-pyridoxine for NVP are reassuring. Evidence is increasing for ginger as an effective herbal remedy for NVP. Metoclopramide is effective in NVP and hyperemesis gravidarum, with a good balance of efficacy and tolerability. A recent large-scale study on first trimester exposure to metoclopramide is reassuring of its safety. Evidence is emerging for the treatment of acid reflux to ameliorate NVP. The role of corticosteroids for hyperemesis gravidarum remains controversial. Transpyloric feeding may be warranted for persistent weight loss, despite optimal antiemetic therapy. SUMMARY: Women with significant NVP should be identified so that they can be safely and effectively treated.

Gamma-glutamyltransferase level in pregnancy is an independent risk factor for gestational diabetes mellitus.

AIM: To evaluate the relationship between gamma-glutamyltransferase (GGT) level in pregnant women at oral glucose tolerance test (OGTT) and the diagnosis of gestational diabetes (GDM). METHODS: Blood was taken for analyzing GGT level from women at high risk of GDM at the time of their scheduled OGTT. GDM was diagnosed according to World Health Organization 1999 criteria. RESULTS: GGT level correlated positively with the 2-hour glucose level (Spearman's rho = 0.112: P < 0.05). GGT values that were stratified into quartiles demonstrated a significant trend with diagnosis of GDM (chi(2) for trend; P = 0.03). Multivariable logistic regression analysis taking into account maternal age, gestational age at OGTT, body mass index and a positive 50-g glucose challenge test (GCT) indicated that high GGT was an independent risk factor for GDM (adjusted odds ratio [AOR] 2.1 95% CI 1.2-3.8: P = 0.01). In the subset of women identified by a positive GCT, on multivariable logistic regression analysis, only high GGT was an independent risk factor for GDM (AOR 2.3 95% CI 1.3-4.2: P = 0.007). CONCLUSION: Raised GGT level is an independent risk factor for GDM in high risk pregnant women undergoing OGTT.

Pregnancy outcome in hyperemesis gravidarum and the effect of laboratory clinical indicators of hyperemesis severity.

OBJECTIVE: To determine pregnancy outcome in hyperemesis gravidarum and the effect of metabolic, biochemical, hematological and clinical indicators of disease severity on outcome. STUDY DESIGN: A retrospective study based on 166 women hospitalized for confirmed hyperemesis gravidarum from January 2004 to January 2005. For each woman, three controls matched for age, parity and ethnicity were obtained from our 2004 birth register. The effects of laboratory indicators of hyperemesis severity were separately analyzed within the hyperemesis gravidarum study group. Outcome measures include stillbirths, Apgar score, mode of delivery, low birthweight, preterm delivery, labor induction, pregnancy induced hypertension and gestational diabetes. Analysis was by t-test, Fisher's exact test and multivariable logistic regression analysis. RESULTS: Women with hyperemesis had similar pregnancy outcome compared to controls. In the analysis of laboratory indicators of hyperemesis severity and pregnancy outcomes, hypokalemia (adjusted odds ratio [AOR] 2.7: 95% confidence interval [CI] 1.0-6.8) was associated with emergency operative delivery, high creatinine (odds ratio 4.4: 95% CI 1.3-15) with labor induction and raised gamma glutamyltransferase (AOR 7.5: 95% CI 1.2-46) with the development of gestational diabetes. CONCLUSIONS: Hyperemesis gravidarum per se was not associated adverse pregnancy outcome. Hypokalemia, high creatinine and raised gamma glutamyltransferase in women with hyperemesis gravidarum were associated with adverse pregnancy outcome.