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.

Millennium development goal 5: a review of maternal mortality at the Kenyatta National Hospital, Nairobi.

OBJECTIVES: To review if there is a change in the maternal mortality rate at the Kenyatta National Hospital since the inception of the Millennium Development Goal strategy in 1990, compared to earlier reviews. DESIGN: A retrospective descriptive study. SETTING: Kenyatta National Hospital. SUBJECTS: Maternal deaths attributed directly to obstetric causes. MAIN OUTCOME MEASURES: Determination of maternal mortality rates of all patients admitted to the Kenyatta National Hospital Maternity and died after admission up till six weeks of admission. Also determine any avoidable causes of the same. RESULTS: During the period under review, there were 27,455 deliveries and 253 maternal deaths giving a maternal mortality ratio of 921.5 per 100,000 live births. Direct obstetric causes accounted for 71% of all maternal deaths with sepsis, haemorrhage, and hypertension being the leading causes. Respiratory tract infections associated with HIV/ AIDS infection was the prominent indirect cause. 67.5% of deaths occurred in women aged between 25 and 35 years and 78.7% were Para 2 or less. Evidently there was poor antenatal clinic attendance with only 28.6% having had any attendance at all. CONCLUSION: Antenatal clinic attendance needs to be re-emphasised if an impact is to be realised in curbing maternal mortality; moreover there is need for early referrals and encouraging mothers to deliver under skilled care.

Resistance to chloroquine therapy in pregnant women with malaria parasitemia.

OBJECTIVES: The objective of the study was to determine the efficacy of chloroquine in pregnant women with Plasmodium falciparum parasitemia at therapeutic doses of 25 mg/kg body weight divided over 3 days. METHODS: Three-hundred pregnant women in Kilifi Hospital at the coast of Kenya were screened for malaria parasitemia using Giemsa stained thick blood smears. In vivo and in vitro parasite sensitivity to chloroquine was determined. RESULTS: P. falciparum infections were present in 65 (22%) of 300 pregnant women. The in vivo tests showed that 46% of all the P. falciparum infections were resistant to chloroquine predominantly at RI and RII levels. The in vitro tests showed a resistance rate of 35%. CONCLUSIONS: A large proportion of pregnant women with malaria do not respond to chloroquine therapy and alternative drugs are required.

A knowledge, attitude and practice survey on sexually transmitted diseases among undergraduate students in a university in Kenya.

PIP: In this study, 273 university students (161 men and 112 women) were interviewed by means of a self-administered questionnaire to determine their knowledge, attitude, and practice concerning sexually transmitted diseases (STDs). The mean age of the men was 22.4 +or- 1.6 years and that of the women was 22.1 +or- 1.6 years. 97.4% of the students were sexually experienced. Knowledge of common STDs was high, but knowledge of their signs, symptoms, and consequences was low. 24.5% of the male and 3.7% of the female students had had an STD. The principal sources of information on STDs included books, films, and TV for 39.6% of the students and teachers for 16.8% of the students. Parents played a very minimal role. It is suggested that primary and secondary school students be taught about STDs as part of reproductive health education and that such education be continued at the college level in order to increase the awareness among young people.^ieng

In vivo and in vitro response of Plasmodium falciparum to chloroquine in pregnant women in Kilifi district, Kenya.

In a malaria-endemic area of the Coast of Kenya with chloroquine resistant Plasmodium falciparum, we determined the prevalence and density of falciparum infection in gravid women and assessed the in vivo and in vitro parasite response to a regimen of chloroquine 25 mg/kg body weight divided over three days. P. falciparum infections were present in 65 (21.7%) of 300 pregnant women. The proportion of primigravidae who were parasitaemic was 41.8% which was significantly higher than that of the multigravidae (17.1, P less than 0.01). Primigravidae did not show a significantly higher mean parasite density than the multigravidae. The in vivo tests showed that 45.9% of all the P. falciparum infections were resistant to chloroquine predominantly at RI and RII levels with percentages 36.1% and 8.2%, respectively.

PIP: At the antenatal clinic of Kilifi District Hospital in the Coast Province of Kenya, researchers enrolled 300 pregnant volunteers 15-32 years olds, living in the district to screen and treat then for Plasmodium falciparum infection and to follow those with parasitemia on days 0, 1, 2, 14, 17, 21, and 28. They also conducted in vitro studies to determine resistance to chloroquine. They combined in vivo and in vitro study took place between November 20, 1988 and January 17, 1989. 65 women (21.7%) had P. falciparum in their peripheral blood smear. Primigravidae were more likely to be parasitemia than were multigravidae (41.8% vs. 17.1%; p .001). Their mean parasite density was also higher but not significantly so. Parasite density fell consistently with rising parity. Malaria infections in 54.1% of the women responded to 25 mg/kg chloroquine. the remaining 45.9% (28) of cases exhibited in vivo resistance, especially at RI an RII levels (36.1% and 8.2%, respectively). Primigravidae were more likely to experience failure to clear parasites by day 7 than multigravidae. Further, among women experiencing a parasitemia on day 7, parasites tended to reappear on day 14 and 21 in primigravidae. Initial parasite density did not affect clearance of parasites. Primigravidae continued to have a higher level of parasitemia throughout treatment than did multigravidae. It took at least 24 hours for the chloroquine to be completely absorbed thus the mean level of parasitemia decreased sharply between 0-2 days. Amodiaquine induced a parasitemia in 89.3% (25 cases) of the chloroquine resistant infections. Even though the 3 remaining cases with parasitemia received amodiaquine treatment, clinicians administered Fansidar, resulting in a clearing of parasitemia in 7 days. 34.8% of in vitro parasite cultures were resistant to chloroquine. The reduced ability of pregnant women to clear parasitemia likely explained the lower level of in vitro resistance.

A knowledge; attitude and practice survey on contraception among male and female undergraduate students in a University in Kenya

A total of 273 university students (161 males and 112 females) were interviewed by means of a self administered questionnaire to determine their knowledge; attitude and practice on contraception. Relatively high levels of knowledge of contraception were found though usage was low. Of the female students who had been sexually active over the previous month; 40.5 per cent had exposed themselves to the risk of pregnancy. It is suggested that reproductive health education should be introduced in primary and secondary school as part of formal education; and continued to college level in order to sensitize the students to their own health needs

Menstrual regulation in Nairobi between October 1982 and October 1985.

PIP: The efficacy and complication rate of menstrual regulation with the hand-held Karman cannula was tested on 223 women with amenorrhea up to 56 days in the Dept. of Obstetrics and Gynecology, University of Nairobi, Kenya from October 1982-January 1983. 195 women had positive pregnancy tests, while menstrual regulation was done on the others because of concern over late menses. the procedures were done without anesthesia with a 50 ml vacuum syringe fitted with a self-locking plunger, a rubber adaptor and stop cock, 5-8 mm flexible plastic Karman cannula and a toothless volsellum, using hibitane solution and savlon antiseptic. The average procedure time was 7 minutes. Bleeding lasted over 1 week in 4%, total blood loss was over 50 ml in 3.1%, and immediate side effects were syncope in 1.3%, nausea and vomiting in 1.8% and pain in 5.4%. There were 2 (0.8%) cases of endometritis. In Kenya where 60% of all gynecological hospital admissions are for septic abortions, it is essential to provide safe termination as a backup for family planning method failures.^ieng