Peripartum interventions resulting in reduced perinatal mortality rates, and birth asphyxia rates, over 18 years in a tertiary centre in South India: a retrospective study.

OBJECTIVE: To study the changes in the rates of perinatal mortality, birth asphyxia, and caesarean sections in relation to interventions implemented over the past 18 years, in a tertiary centre in South India. DESIGN: Retrospective study. SETTING: Labour and maternity unit of a tertiary centre in South India. POPULATION OR SAMPLE: Women who gave birth between 2000 and 2018. METHODS: Information from perinatal audits, chart reviews, and data retrieved from the electronic database were used. Interventions implemented during this time period were audits and training, obstetric re-organisation, and minor changes in staffing and infrastructure. MAIN OUTCOME MEASURES: Main outcome measures were perinatal mortality rate, birth asphyxia rate, and caesarean section rate. RESULTS: Perinatal mortality rate decreased from 44 per 1000 births in 2000 to 16.4 per 1000 births in 2018 (P < 0.001). The rates of babies born with birth asphyxia requiring admission to the neonatal unit decreased from 24 per 1000 births in 2001 to 0.7 per 1000 births in 2018 (P < 0.00001). The overall caesarean section rate was maintained close to 30%. CONCLUSION: In a large tertiary hospital in South India, with 14 000 deliveries per year, a policy of rigorous audits of stillbirths and birth asphyxia, electronic fetal monitoring, and the introduction of standardised criteria for trial of scar, reduced the perinatal mortality and the rate of babies born with birth asphyxia over the past 18 years, without an increase in the caesarean section rate. TWEETABLE ABSTRACT: Rigorous perinatal audits with training in fetal cardiotocography, decreased birth asphyxia, without a major increase in caesarean rates.

Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial.

BACKGROUND: The CORONIS trial reported differences in short-term maternal morbidity when comparing five pairs of alternative surgical techniques for caesarean section. Here we report outcomes at 3 years follow-up. METHODS: The CORONIS trial was a pragmatic international 2 × 2 × 2 × 2× 2 non-regular fractional, factorial, unmasked, randomised controlled trial done at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. In this follow-up study, we compared outcomes at 3 years following blunt versus sharp abdominal entry, exteriorisation of the uterus for repair versus intra-abdominal repair, single versus double layer closure of the uterus, closure versus non-closure of the peritoneum, and chromic catgut versus polyglactin-910 for uterine repair. Outcomes included pelvic pain; deep dyspareunia; hysterectomy and outcomes of subsequent pregnancies. Outcomes were assessed masked to the original trial allocation. This trial is registered with the Current Controlled Trials registry, number ISRCTN31089967. FINDINGS: Between Sept 1, 2011, and Sept 30, 2014, 13,153 (84%) women were followed-up for a mean duration of 3·8 years (SD 0·86). For blunt versus sharp abdominal entry there was no evidence of a difference in risk of abdominal hernias (adjusted RR 0·66; 95% CI 0·39-1·11). We also recorded no evidence of a difference in risk of death or serious morbidity of the children born at the time of trial entry (0·99, 0·83-1·17). For exteriorisation of the uterus versus intra-abdominal repair there was no evidence of a difference in risk of infertility (0·91, 0·71-1·18) or of ectopic pregnancy (0·50, 0·15-1·66). For single versus double layer closure of the uterus there was no evidence of a difference in maternal death (0·78, 0·46-1·32) or a composite of pregnancy complications (1·20, 0·75-1·90). For closure versus non-closure of the peritoneum there was no evidence of a difference in any outcomes relating to symptoms associated with pelvic adhesions such as infertility (0·80, 0·61-1·06). For chromic catgut versus polyglactin-910 sutures there was no evidence of a difference in the main comparisons for adverse pregnancy outcomes in a subsequent pregnancy, such as uterine rupture (3·05, 0·32-29·29). Overall, severe adverse outcomes were uncommon in these settings. INTERPRETATION: Although our study was not powered to detect modest differences in rare but serious events, there was no evidence to favour one technique over another. Other considerations will probably affect clinical practice, such as the time and cost saving of different approaches. FUNDING: UK Medical Research Council and the Department for International Development.

Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial.

BACKGROUND: Variations exist in the surgical techniques used for caesarean section and many have not been rigorously assessed in randomised controlled trials. We aimed to assess whether any surgical techniques were associated with improved outcomes for women and babies. METHODS: CORONIS was a pragmatic international 2×2×2×2×2 non-regular fractional, factorial, unmasked, randomised controlled trial that examined five elements of the caesarean section technique in intervention pairs. CORONIS was undertaken at 19 sites in Argentina, Chile, Ghana, India, Kenya, Pakistan, and Sudan. Each site was assigned to three of the five intervention pairs: blunt versus sharp abdominal entry; exteriorisation of the uterus for repair versus intra-abdominal repair; single-layer versus double-layer closure of the uterus; closure versus non-closure of the peritoneum (pelvic and parietal); and chromic catgut versus polyglactin-910 for uterine repair. Pregnant women were eligible if they were to undergo their first or second caesarean section through a planned transverse abdominal incision. Women were randomly assigned by a secure web-based number allocation system to one intervention from each of the three assigned pairs. All investigators, surgeons, and participants were unmasked to treatment allocation. The primary outcome was the composite of death, maternal infectious morbidity, further operative procedures, or blood transfusion (>1 unit) up to the 6-week follow-up visit. Women were analysed in the groups into which they were allocated. The CORONIS Trial is registered with Current Controlled Trials: ISRCTN31089967. FINDINGS: Between May 20, 2007, and Dec 31, 2010, 15 935 women were recruited. There were no statistically significant differences within any of the intervention pairs for the primary outcome: blunt versus sharp entry risk ratio 1·03 (95% CI 0·91-1·17), exterior versus intra-abdominal repair 0·96 (0·84-1·08), single-layer versus double-layer closure 0·96 (0·85-1·08), closure versus non-closure 1·06 (0·94-1·20), and chromic catgut versus polyglactin-910 0·90 (0·78-1·04). 144 serious adverse events were reported, of which 26 were possibly related to the intervention. Most of the reported serious adverse events were known complications of surgery or complications of the reasons for the caesarean section. INTERPRETATION: These findings suggest that any of these surgical techniques is acceptable. However, longer-term follow-up is needed to assess whether the absence of evidence of short-term effects will translate into an absence of long-term effects. FUNDING: UK Medical Research Council and WHO.

Acenocoumarol and phenytoin toxicity in the presence of CYP2C9 mutation.

This case report describes a rare interaction between therapeutic doses of phenytoin and acenocoumarol resulting in both acute phenytoin toxicity and increased international normalized ratio (INR). Interactions between these drugs are due to the pharmacokinetics and the common metabolising pathway by hepatic cytochrome P450 isoenzyme-CYP2C9. Our patient was detected to be homozygous for CYP2C9*3 by PCR-RFLP analysis resulting in markedly decreased metabolism of both the drugs. Given that these two drugs are often given concomitantly in the medical out patient department, and that CYP2C9 polymorphisms are not uncommon, clinicians should be aware of this interaction and suspect this in patients with toxicity to these drugs.

Comparison of two World Health Organization partographs.

OBJECTIVE: To compare two World Health Organization (WHO) partographs - a composite partograph including latent phase with a simplified one without the latent phase. METHOD: Comparison of the two partographs in a crossover trial. RESULT: Eighteen physicians participated in this trial. One or the other partograph was used in 658 parturients. The mean (S.D.) user-friendliness score was lower for the composite partograph (6.2 (0.9) vs. 8.6 (1.0); P=0.002). Most participants (84%) experienced difficulty "sometimes" with the composite partograph, but no participant reported difficulty with the simplified partograph. While most maternal and perinatal outcomes were similar, labor values crossed the action line significantly more often when the composite partograph was used, and the women were more likely to undergo cesarean deliveries. CONCLUSION: The simplified WHO partograph was more user-friendly, was more to be completed than the composite partograph, and was associated with better labor outcomes.

Malignant hyperthermia.

Malignant hyperthermia of anesthesia is a severe complication and must be treated vigorously. The anesthetic should be stopped and the core body temperature reduced. Systemic complications must be anticipated, hopefully prevented, and appropriately treated. Appropriate laboratory studies must be obtained. A comprehensive family survey may alert the physician to a tendency toward this problem. Temperature monitoring during surgery may give an early warning of malignant hyperthermia developing. I would suggest that routine temperature monitoring during surgery be considered by the anesthesia department during each general anesthetic administration.

Uterine rupture in a multiparous woman during labor induction with oral misoprostol.

A multigravida with gestational diabetes, mild pregnancy-induced hypertension and a previous curettage received four doses of misoprostol (100 microg) at three hourly intervals for induction of labor at term. Vaginal delivery of a live healthy baby occurred 1 h after the fourth dose. Hindwaters were bloodstained. Three hours later, she had excessive bleeding. Examination showed that the left lateral uterine wall had ruptured. She recovered after hysterectomy and blood transfusions.

The physician self-referral dilemma: enforcing antitrust law as a solution.

As health care reform pervades the United States, lawmakers have subjected physician self-referrals to heightened scrutiny. Recent evidence indicates that sending patients to facilities in which a physician has an ownership interest often causes overutilization, overpricing, and lower quality of care. This Note analyzes how physician self-referral arrangements can have negative effects on competition. To combat the adverse effects, the Note examines how enforcing antitrust laws can ameliorate the self-referral dilemma and aid in restoring competition to the health care market. This solution will maintain the doctor's right to invest while protecting the patient's vulnerability.

The Griess test: an inexpensive screening test for asymptomatic bacteriuria in pregnancy.

This study was designed to compare urine microscopy and the Griess test as screening tests for asymptomatic bacteriuria (AB) in pregnancy, using urine culture as a gold standard. Urine microscopy, Griess test and urine culture were carried out on urine samples from 483 antenatal women. AB was detected by urine culture in 30 (6.8%) of the patients. The Griess test and urine microscopy were found to have a sensitivity of 63.3% and 60%, specificity of 99.5% and 83.6%; and positive predictive value of 90.5% and 21.1% respectively. Most of the infections missed by the Griess test were either <100,000 colony count on culture or caused by gram positive cocci. The cost of the Griess test was only one tenth of that of urine microscopy. The Griess test is a simple and inexpensive test that when compared to urine microscopy has equal sensitivity, and better specificity and positive predictive value for the detection of AB in pregnancy than urine microscopy.

Target-directed enediynes: designed estramycins.

The goal of selective targeting of enediyne cytotoxins has been investigated using estrogenic delivery vehicles. A series of estrogen-enediyne conjugates were assembled, and affinity for human estrogen receptor [hERalpha] was determined. The most promising candidate induced receptor degradation following Bergman cycloaromatization and caused inhibition of estrogen-induced transcription in T47-D human breast cancer cells.