Is metformin indicated as primary ovulation induction agent in women with PCOS? A systematic review and meta-analysis.

BACKGROUND: A recent meta-analysis has proven that metformin (M) is highly effective for ovulation induction in the clomiphene citrate (CC)-resistant patient. There is uncertainty whether M should be introduced as a primary ovulation induction agent in polycystic ovarian syndrome (PCOS). METHODS: We conducted a systematic review and meta-analysis to establish if M is better when given alone or in combination with CC (CC+M) when compared with CC alone. This systematic review studied live birth delivery rate as the primary outcome. RESULTS: We identified 14 prospective trials. Analysis of these results showed a reduction in the live birth rate in the group of patients treated only with M when compared with CC alone (OR = 0.48, 95% CI 0.31-0.73, p = 0.0006). An increase in ovulation (OR = 1.6, 95% CI 1.2-2.1, p = 0.0009) and pregnancy rate (OR = 1.3, 95% CI 1.0-1.6, p = 0.05) with CC+M when compared with CC alone was reported, but no difference was found when live birth rate was analyzed (OR = 1.1, 95% CI 0.8-1.5, p = 0.61). CONCLUSION: CC alone is superior to M alone regarding live birth rate and ovulation. The combination (CC+M) is superior to CC alone as a primary method for ovulation induction and to achieve pregnancy in PCOS. However, when addressing live birth rate, no statistically significant difference could be demonstrated. Because of the side effects profile and contraindications of M, we believe M should not be indicated as a primary ovulation induction agent in women with PCOS.

Fallopian tube reanastomosis by laparotomy versus laparoscopy: a meta-analysis.

OBJECTIVE: To compare efficacy of sterilization reversals by laparotomy versus laparoscopy. DESIGN: Meta-analysis. SEARCH STRATEGY: Electronic searches were carried out for randomized controlled trials and retrospective and prospective clinical studies. Search engines such as PubMed, Science Direct, Medline and the Cochrane database were made use of. Our restrictions were English human studies published from 1989 to January 2010. INTERVENTIONS: Microsurgical tubal reanastomosis performed comparing laparoscopy with laparotomy using a microsurgical technique. OUTCOME MEASURES: Primary: overall pregnancy rates, including positive clinical pregnancy, intrauterine and ectopic pregnancy rates. Secondary: surgery time. RESULTS: Three retrospective comparative studies were retrieved from international data that investigated laparotomy versus laparoscopy. A total number of 184 patients were included, 88 and 96 respectively undergoing laparoscopy and laparotomy. Pregnancy rates achieved by laparoscopy ranged from 65 to 80.5% (mean 74.43%) and by laparotomy from 70 to 80% (mean 71.33%). A subanalysis of two of the three comparative studies show that laparoscopy reversal surgery requires a statistically significant longer operative time than does laparotomy (p < 0.00001). CONCLUSIONS: There is no difference between the laparoscopy and laparotomy approach to tubal reanastomosis when regarding overall pregnancy rates, intrauterine and ectopic pregnancy rates.

PIERS proteinuria: relationship with adverse maternal and perinatal outcome.

OBJECTIVE: To examine the ability of three different proteinuria assessment methods (urinary dipstick, spot urine protein:creatinine ratio [Pr/Cr], and 24-hour urine collection) to predict adverse pregnancy outcomes. METHODS: We performed a prospective multicentre cohort study, PIERS (Preeclampsia Integrated Estimate of RiSk), in seven academic tertiary maternity centres practising expectant management of preeclampsia remote from term in Canada, New Zealand, and Australia. Eligible women were those admitted with preeclampsia who had at least one antenatal proteinuria assessment by urinary dipstick, spot urine Pr/Cr ratio, and/or 24-hour urine collection. Proteinuria assessment was done either visually at the bedside (by dipstick) or by hospital clinical laboratories for spot urine Pr/Cr and 24-hour urine collection. We calculated receiver operating characteristic area under the curve (95% CI) for each proteinuria method and each of the combined adverse maternal outcomes (within 48 hours) or adverse perinatal outcomes (at any time). Models with AUC ≥ 0.70 were considered of interest. Analyses were run for all women who had each type of proteinuria assessment and for a cohort of women ("ALL measures") who had all three proteinuria assessments. RESULTS: More women were proteinuric by urinary dipstick (≥ 2+, 61.4%) than by spot urine Pr/Cr (≥ 30 g/mol, 50.4%) or 24-hour urine collection (≥ 0.3g/d, 34.7%). Each proteinuria measure evaluated had some discriminative power, and dipstick proteinuria (categorical) performed as well as other methods. No single method was predictive of adverse perinatal outcome. CONCLUSION: The measured amount of proteinuria should not be used in isolation for decision-making in women with preeclampsia. Dipstick proteinuria performs as well as other methods of assessing proteinuria for prediction of adverse events.

Abortion care training framework for nurses within the context of higher education in the Western Cape.

The high morbidity and mortality rate due to illegal abortions in South Africa necessitated the implementation of abortion legislation in February 1997. Abortion legislation stipulates that registered nurses who had undergone the proposed abortion care training--certified nurses--may carry out abortions within the first 12 weeks of pregnancy. Currently it seems that an inadequate number of nurses are being trained in the Western Cape to provide pregnant women with counselling, to perform abortions and/or refer problem cases. No real attempts have since been made by higher education institutions in the Western Cape to offer abortion care training for nurses. This case study explores the situation of certified nurses and the context in which they provide abortion care in different regions of the Western Cape. The sampling included a random, stratified (non-proportional) number of designated state health care facilities in the Western Cape, a non-probability purposive sampling of nurses who provided abortion care, a non-probability convenience sample of women who had received abortion care, and a non-probability purposive sampling of final-year pre-registration nursing students. Data was generated by means of questionnaires, a checklist and semi-structured interviews. The main findings of this study indicate that the necessary infrastructure required for legal abortion is in place. However, the ongoing shortage of trained health care practitioners hampers abortion care services. Deficiencies were identified in the existing provincial protocol as some of the guidelines were either not in use or had become obsolete. Certified midwives who had been trained by the regional offices of the Department of Health: Western Cape were skilled in carrying out the abortion procedure, but other aspects of abortion care mainly carried out by other categories of nurses required more attention. This article suggests a training framework that should provide focus for the development of a formal programme or programmes for the training of nurses in abortion care at higher education institutions in the Western Cape.

Low-dose dopamine for women with severe pre-eclampsia.

BACKGROUND: Hypertensive disorders during pregnancy are important causes of maternal mortality and morbidity worldwide. The long-term outcome of surviving mothers will depend largely on whether intracranial haemorrhage or renal failure developed. Low-dose dopamine is used for the prevention and treatment of acute renal failure, but its role in the management of pregnant women with severe pre-eclampsia is unclear. OBJECTIVES: To assess the effects of low-dose dopamine used for oliguria in severe pre-eclampsia on mothers and their children. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2006). SELECTION CRITERIA: Randomised trials comparing low-dose dopamine (dosages not higher than 5 microgram/kg/minute) with either placebo or no dopamine in women with severe pre-eclampsia and acute renal failure, or who are considered to be at risk of acute renal failure. DATA COLLECTION AND ANALYSIS: The two review authors assessed trial quality and data independently. MAIN RESULTS: Only one randomised placebo controlled trial of six hours' duration, including 40 postpartum women, was found. This study showed a significant increase in urinary output over six hours in women receiving dopamine. It is unclear if this was of any benefit to the women. AUTHORS' CONCLUSIONS: It is unclear whether low-dose dopamine therapy for pre-eclamptic women with oliguria is worthwhile. It should not be used other than in prospective trials.

Antihypertensive drug therapy for mild to moderate hypertension during pregnancy.

BACKGROUND: Mild to moderate hypertension during pregnancy is common. Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve outcome. OBJECTIVES: To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 3), MEDLINE (1966 to November 2005), LILACS (1984 to November 2005) and EMBASE (1974 to November 2005). SELECTION CRITERIA: All randomised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy defined, whenever possible, as systolic blood pressure 140 to 169 mmHg and diastolic blood pressure 90 to 109 mmHg. Comparisons were of one or more antihypertensive drug(s) with placebo, with no antihypertensive drug, or with another antihypertensive drug, and where treatment was planned to continue for at least seven days. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. MAIN RESULTS: Forty-six trials (4282 women) were included. Twenty-eight trials compared an antihypertensive drug with placebo/no antihypertensive drug (3200 women). There is a halving in the risk of developing severe hypertension associated with the use of antihypertensive drug(s) (19 trials, 2409 women; relative risk (RR) 0.50; 95% confidence interval (CI) 0.41 to 0.61; risk difference (RD) -0.10 (-0.12 to -0.07); number needed to treat (NNT) 10 (8 to 13)) but little evidence of a difference in the risk of pre-eclampsia (22 trials, 2702 women; RR 0.97; 95% CI 0.83 to 1.13). Similarly, there is no clear effect on the risk of the baby dying (26 trials, 3081 women; RR 0.73; 95% CI 0.50 to 1.08), preterm birth (14 trials, 1992 women; RR 1.02; 95 % CI 0.89 to 1.16), or small-for-gestational-age babies (19 trials, 2437 women; RR 1.04; 95 % CI 0.84 to 1.27). There were no clear differences in any other outcomes. Nineteen trials (1282 women) compared one antihypertensive drug with another. Beta blockers seem better than methyldopa for reducing the risk of severe hypertension (10 trials, 539 women, RR 0.75 (95 % CI 0.59 to 0.94); RD -0.08 (-0.14 to 0.02); NNT 12 (6 to 275)). There is no clear difference between any of the alternative drugs in the risk of developing proteinuria/pre-eclampsia. Other outcomes were only reported by a small proportion of studies, and there were no clear differences. AUTHORS' CONCLUSIONS: It remains unclear whether antihypertensive drug therapy for mild to moderate hypertension during pregnancy is worthwhile.

Serotonin antagonism and serotonin antagonists in pregnancy: role of ketanserin.

UNLABELLED: Most agree that antihypertensive medication should be used to treat severe hypertension during pregnancy, but its role in patients with mild to moderate disease is debated. None of the regularly used drugs is completely safe for mother and fetus. Ketanserin decreases systolic and diastolic blood pressure in nonpregnant patients with acute and chronic hypertension. Its selective serotonin S2-receptor antagonist activity encouraged investigations into a possible role in pregnant women. These reports can be divided into four groups. Several studies confirmed that intravenous ketanserin decreases blood pressure significantly in patients with severe preeclampsia. There are indications that it may be at least as effective as dihydralazine, possibly with fewer side effects. Its role in chronic hypertension has not been studied adequately, but one randomized, controlled trial indicated efficacy comparable with that of alpha-methyldopa. Thirdly, it was concluded in a single descriptive study that the administration of ketanserin to patients with HELLP syndrome allowed delivery to be postponed for 5.3 days. Lastly, in a randomized, placebo-controlled trial, the addition of ketanserin to aspirin in patients with mild to moderate midtrimester hypertension was associated with a significant decrease in the number of cases of preeclampsia and severe hypertension, as well as a trend to less perinatal mortality, lower rates of abruptio placentae, and early-onset preeclampsia. Additional studies are needed to adequately assess a possible role for ketanserin with acute hypertension or moderate chronic hypertension. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians LEARNING OBJECTIVES: After completion of this article, the reader will be able to list the various drugs and their associated side effects that are used to treat hypertensive disorders during pregnancy; to describe the various effects of serotonin on the cardiovascular system; to summarize the literature concerning the use of ketanserin during pregnancy; and to list the potential uses of ketanserin in this setting.

Antihypertensive drug therapy for mild to moderate hypertension during pregnancy.

BACKGROUND: Mild-moderate hypertension during pregnancy is common. Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve outcome. OBJECTIVES: To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy. SEARCH STRATEGY: Relevant trials were identified in the register of trials maintained by the Cochrane Pregnancy and Childbirth Group. In addition, the Cochrane Controlled Trial Register, MEDLINE, and EMBASE were searched. Date of last search: October 2000. SELECTION CRITERIA: All randomised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy, defined whenever possible as systolic blood pressure 140-169 mmHg and diastolic blood pressure 90-109 mmHg. Comparisons were of one or more antihypertensive drug(s) with placebo, with no antihypertensive drug, or with another antihypertensive drug, and where treatment was planned to continue for at least seven days. DATA COLLECTION AND ANALYSIS: Data were extracted independently by two reviewers. MAIN RESULTS: Overall, this review includes 40 studies (3797 women), 24 of which compared an antihypertensive drug with placebo/no antihypertensive drug (2815 women). There is a halving in the risk of developing severe hypertension associated with the use of antihypertensive drug(s) [17 trials, 2155 women; relative risk (RR) 0.52 (95% confidence interval (CI) 0.41 to 0.64); risk difference (RD) -0.09 (-0.12 to -0.06); number needed to treat (NNT) 12 (9 to 17)] but little evidence of a difference in the risk of pre-eclampsia [19 trials, 2402 women; RR 0.99 (0.84 to 1.18)]. Similarly, there is no clear effect on the risk of the baby dying [23 trials, 2727 women; RR 0.71(0.46 to 1.09)], preterm birth [12 trials, 1738 women; RR 0.98 (0.85 to 1.13)], or small for gestational age babies [17 trials, 2159 women; RR 1.13 (0.91 to 1.42)]. There were no clear differences in any other outcomes. Seventeen trials (1182 women) compared one antihypertensive drug with another. There is no clear difference between any of these drugs in the risk of developing severe hypertension, and proteinuria/pre-eclampsia. Other antihypertensive agents seem better than methyldopa for reducing the risk of the baby dying [14 trials, 1010 subjects, RR 0.49 (0.24 to 0.99); RD -0.02 (-0.04 to 0.00); NNT 45 (22 to 1341)]. Other outcomes were only reported by a small proportion of studies, and there were no clear differences. REVIEWER'S CONCLUSIONS: It remains unclear whether antihypertensive drug therapy for mild-moderate hypertension during pregnancy is worthwhile.

Dihydralazine or ketanserin for severe hypertension in pregnancy? Preliminary results.

OBJECTIVE: To compare the efficacy and safety of intravenous dihydralazine with ketanserin in the management of severe hypertension in the third trimester. STUDY DESIGN: A double blind randomised controlled trial, comparing 5 mg dihydralazine with 10 mg ketanserin after an intravenous infusion of 500 ml of a crystalloid solution. Medication was repeated every 20 min till the therapeutic goal of 90 mm Hg was reached, to a maximum of 4 dosages. Main outcome measures were treatment failures and emergency deliveries for fetal distress. RESULTS: The therapeutic goal was met more often in patients receiving dihydralazine (36/38 compared to 27/42; P < 0.01). The need for delivery for fetal distress did not differ (3 after dihydralazine, 1 after ketanserin, P = 0.29) No therapy related perinatal loss occurred, but one mother with an undiagnosed phaechromocytoma died 24 h after receiving dihydralazine. CONCLUSION: Ketanserin in this dosage is less effective to lower diastolic blood pressure. The place of a fluid load prior to dihydralazine needs to be further investigated, as fetal heart rate decelerations were less common than previously reported.

Expectant management of severe pre-eclampsia in the mid-trimester.

OBJECTIVE: To determine maternal and perinatal outcomes with expectant management of severe pre-eclampsia in the mid-trimester, using a defined entry point. DESIGN: Prospective case series. Thirty-nine women admitted from 24 to 27 week's gestation with severe pre-eclampsia, whose pregnancies were otherwise stable, were managed expectantly with careful clinical and biochemical monitoring of maternal and foetal status, together with careful blood pressure control, in a high-care obstetric ward. The aim was to safely prolong the pregnancies and thereby improve perinatal outcome. RESULTS: Gestation was prolonged by a median of 12 (range 3--47) days, with greater periods gained at earlier gestations. The overall perinatal loss was 26% and the neonatal loss 17%. The rates of significant maternal complications were low. CONCLUSION: Expectant management of selected women with severe pre-eclampsia from 24 to 27 weeks' gestation in a tertiary care unit is acceptably safe and improves perinatal outcome.

Fetal resuscitation in a patient with varicella pneumonia and preterm labor.

A primigravida presented at 33 weeks gestation with varicella pneumonia. Cardiotocography demonstrated repeated late decelerations of fetal heart rate. Cesarean section was indicated for contracted maternal pelvis and breech presentation, but was decided against because of the risks of anesthesia. Maternal and fetal improvement followed intrauterine resuscitation and suppression of preterm labor. Cesarean section was performed 9 days later after spontaneous rupture of membranes with excellent outcome. The same approach is suggested for similar cases.

Delivery of patients with early onset, severe pre-eclampsia.

OBJECTIVES: To compare the effects of induction/labor to delivery before labor in early onset, severe pre-eclampsia. METHODS: Five-year prospective case series. Delivery course and neonatal outcome were examined for 335 women with viable singletons. RESULTS: Induction was successful in 45% of attempts. Women exposed to labor had longer (5.5 days, P<0.0001) admissions to delivery periods and were more often delivered for maternal indications (RR=2.87, 95% CI=1.98-4.16). Their babies were born 1.6 weeks older (P<0.0001) and 352 g heavier (P<0.0001) than those delivered before labor. Babies exposed to labor needed intensive care less often (RR=0.4, 95% CI=0.27-0.58), had lower rates of severe hyaline membrane disease (RR=0.26, 95% CI=0.11-0.59) and sepsis (RR=0.56, 95% CI=0.33-0.93), and were discharged earlier (P<0.0001). CONCLUSIONS: Exposure to induction/labor in selected patients is not detrimental to neonatal outcome in early, severe pre-eclampsia.

Urinary protein excretion and expectant management of early onset, severe pre-eclampsia.

OBJECTIVE: To evaluate the importance of proteinuria in the expectant management of early onset, severe pre-eclampsia. METHODS: In this prospective series of 340 women, 24-h urine collections were performed and monitored twice weekly in a high-care ward. RESULTS: Seventy-four women with at least two 24-h urine collections were grouped into women with a proteinuria increase of > or =2 g (n=29) and with women whose proteinuria decreased, or increased by <2 g (n=45). Major maternal complications, prolongation of gestation, and perinatal outcomes were comparable. Fifty-six (75%) women experienced an increase in proteinuria. When patients with heavy proteinuria (n=83) were compared to those with moderate proteinuria (n=257), maternal and perinatal outcomes were comparable. More days were gained before delivery in the heavy proteinuria group than in the moderate (12 vs. 9; P<0.001). CONCLUSION: Most patients experienced increased proteinuria. Neither the rate of increase nor the amount of proteinuria affected maternal and perinatal outcomes.

Pregnancy in partially remitted hepatitis B-associated membranous glomerulonephritis.

Hepatitis B-associated glomerulonephritis is a relatively common cause of nephrotic syndrome in endemic areas affecting especially male children. When this disease affects girls or women, both the glomerular disease and the hepatitis B carrier state could affect subsequent pregnancies. This may be the first reported case of such a pregnancy. In this patient the partially remitted renal disease and the reduced infectivity of the hepatitis B carrier state decreased the influence of the disease on the pregnancy.

Trends in caesarean sections at Tygerberg Hospital, South Africa: a 20 year experience.

OBJECTIVE: To investigate the caesarean section (CS) rate and the individual components thereof at Tygerberg Hospital; the trend and its relationship to the perinatal mortality rate. DESIGN: A retrospective study, using data from 1975 to 1994. SETTINGS: Tygerberg Academic Hospital (TBH) is the referral hospital for regional Midwife Obstetric Units (MOU) as well as the tertiary referral hospital for secondary hospitals in the former Cape Province, excluding the Eastern Cape. In the last year of the study there were 7,035 deliveries in TBH, 4,040 deliveries in the MOU and 28,596 in the secondary hospitals. SUBJECTS: 174,713 deliveries and 22,773 CS from 1975 to 1994. MAIN OUTCOME MEASURE: The individual components of the CS rate. RESULTS: The CS rate stayed constant at about 13%. The perinatal mortality rate declined from 34.7/1000 to 18.4/1000. CONCLUSION: A low, constant CS rate can be maintained without compromising the perinatal mortality rate.

PIP: This is a retrospective study of the cesarean sections (CS) done at Tygerberg Hospital in South Africa and of their relationship to the perinatal mortality (PNM) rate. The annual CS rate from 1975 to 1994 was used in this study. Information was obtained from maternity registers and annual department reports. A total of 174,713 deliveries were registered within a 20-year period. Some 155,257 were booked patients and 19,456 were unbooked. The results show a significant difference in CS rate between booked (12.2%) and unbooked (16.9%) patients. The four main indications for CS in 1975, 1985, and 1994 were dystocia, previous CS, breech presentation, and fetal distress, all in varied percentages. In 1993 there were 224 vaginal breech deliveries and 162 CS for breech presentations; this yields a 41.9% CS rate for breech presentations and 2.3% for all vaginal deliveries. The PNM rate declined from 34.7/1000 in 1975 to 18.4/1000 in 1994. The experience at Tygerberg Hospital demonstrates that the rate of CS delivery can remain constant while the PNM rate drops.

Is the Use of a GnRH Antagonist Effective in Patients with Polycystic Ovarian Syndrome? A South African Perspective

Introduction. Polycystic ovarian disease (PCOS) can account for up to 35 - 40 of the female factor causes of infertility. These patients present as medically complex cases and are challenging to manage and treat successfully. They are resistant to treatment and are often offered controlled ovarian stimulation (COS) and in vitro fertilisation (IVF) technology. Aim. The aim of this study was to assess whether there was a difference in the pregnancy outcomes of women with PCOS when a standard gonadotrophin-releasing hormone (GnRH) antagonist (cetrorelix) protocol was used for ovarian stimulation; compared with non-PCOS patients undergoing IVF. Methods. A retrospective patient record audit was performed on 142 patients with PCOS and 501 non-PCOS patients undergoing a similar cetrorelix-based COS treatment protocol during a specified time period. Results. The main primary outcome was an ongoing pregnancy at 12 weeks; achieved in 34 of patients in the PCOS group and 27 in the non-PCOS group. This was not significantly different (p=0.07). No patient in the PCOS group experienced severe hyperstimulation syndrome. Conclusion. There was no significant difference in pregnancy rates in patients with PCOS undergoing GnRH-antagonist ovarian stimulation compared with non-PCOS patients. The fact that no hyperstimulation syndrome occurred makes this an attractive option for women with PCOS

Effect of fibroids on fertility in patients undergoing assisted reproduction. A structured literature review.

OBJECTIVE: The aim of this study is to evaluate the current data to understand the impact of intramural leiomyomata on pregnancy outcome in assisted reproduction. PATIENTS AND METHODS: In this review, articles were found by means of computerized Medline and Cochrane Library search using the key words uterine myomata, leiomyomata, fibroids, implantation, pregnancy, infertility and in vitro fertilization. Limitations were English, human, 1990-2002. Inclusion criteria were pregnancy data on in vitro fertilization, intramural myomata with no cavitary distortion and control groups without myomas for each patient with a myoma. RESULTS: There was a significant negative impact on implantation rate in the intramural myomata groups versus the control groups, 16.4 vs. 27.7% OR 0.62 (0.48-0.8). The delivery rate per transfer cycle was also significantly lower (myomata vs. control), 31.2 vs. 40.9% OR 0.69 (0.50-0.95). CONCLUSION: Our study supports the notion that patients with intramural fibroids have a lower implantation rate per cycle. The studies did not shed new light on the size of intramural myomata that could affect the outcome. In previous failed in vitro fertilization cycles, microsurgical removal of myomata must be considered.

Computerised cardiotocography in a high-risk unit in a developing country--its influence on inter-observer variation and duration of recording.

OBJECTIVE: To determine the role of computer-assisted cardiotocography in an obstetric special care unit and its influence on inter-observer variation in interpretation, proposed management and monitoring time. DESIGN: A prospective comparative study. SETTING: The obstetric special care unit, Tygerberg Hospital, W. Cape. STUDY POPULATION: A group of 10 registrars in obstetrics who have had experience in the interpretation of both standard and computer-assisted cardiotocographs. MAIN OUTCOME MEASURES: The influence of method of cardiotocograph recording on inter-observer variation in respect of suggested management of the patient, as well as the observer's opinion of the duration of the recording. RESULTS: Variation in suggested management decreased significantly after assessment of the computer reports, compared with the standard cardiotocographs. While delivery was regarded to be indicated in 3.5% of patients and an immediate repeat of the cardiotocograph in a further 10%, no such action was proposed after evaluation of the computer reports of the same recordings. Thirty-four per cent of tracings were considered to have been too long and 12.5% too short. However, suggested management in 40% of the latter cases seemed inappropriate for tracings regarded as of too short a duration. CONCLUSION: While computer-assisted cardiotocographs significantly decrease inter-observer variation in the proposed management of patients, its cost-effectiveness in an obstetric special care unit in a developing country should be validated, as it might increase monitoring time.

Mid-trimester termination of pregnancy--a randomised controlled trial of two prostaglandin regimens.

OBJECTIVE: To determine the more applicable of two ways of prostaglandin induction currently in use in second trimester induced abortions for congenital or chromosomal abnormalities. DESIGN: A prospective randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Tygerberg Hospital, CP. STUDY POPULATION: Twenty consecutive patients admitted for termination of pregnancy for congenital or chromosomal abnormalities between 14 and 26 weeks' pregnancy duration. MANAGEMENT: Patients were randomly selected to receive either 1.5 mg prostaglandin E2 (PGE2) gel extra-amniotically or 25 mg prostaglandin F2 alpha (PGF2 alpha) intra-amniotically. Patients in both groups received oxytocin to a maximum dosage of 120 mU per minute if they had not aborted 18 hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 hours after commencement of treatment, management was considered unsuccessful. MAIN OUTCOME MEASUREMENTS: Proportion of successful inductions and complications. RESULTS: Complications of management were rare and did not differ between the two management groups. However, there were significantly more failures in the group who received intra-amniotic PGF2 alpha (7 v. 2 patients) as well as a significantly higher need for oxytocin in this group (10 v. 4 patients). CONCLUSIONS: With promising drugs such as prostaglandin analogues and anti-progesterones not universally available, methods of induction suitable to the local situation should be sought. Extra-amniotic PGE2 seems more suitable than intra-amniotic PGF2 alpha because of a shorter induction-to-delivery time without increased morbidity.

Randomised controlled trial of ketanserin and aspirin in prevention of pre-eclampsia.

BACKGROUND: Pre-eclampsia is associated with extensive endothelial-cell damage and platelet activation, resulting in lower production of vasodilator prostaglandins and increased release of the vasoconstrictors thromboxane A2 and serotonin. Damage to endothelial-cell serotonin-1 receptors leaves vasoconstriction and platelet aggregation mediated by serotonin-2 receptors unopposed. We investigated the role of ketanserin, a selective serotonin-2-receptor antagonist, in lowering the rate of pre-eclampsia among pregnant women with mild to moderate hypertension. METHODS: We recruited 138 pregnant women into a double-blind, randomised, placebo-controlled trial. They had diastolic blood pressure persistently more than 80 mm Hg before 20 weeks' gestation. 69 women received ketanserin and 69 received placebo. Both groups also received aspirin. Patients were initially given two tablets daily, increased to four tablets daily in diastolic blood pressure was more than 90 mm Hg. Primary outcomes were the development of pre-eclampsia and severe hypertension, and perinatal mortality. FINDINGS: There were significantly fewer cases of pre-eclampsia (two vs 13; relative risk 0.15 [95% CI 0.04-0.66], p = 0.006) and severe hypertension (six vs 17; p = 0.02) in the ketanserin than in the placebo group. There was also a trend towards less perinatal mortality (one vs six deaths) but this was not significant (p = 0.28). Rates of abruptio placentae and pre-eclampsia before 34 weeks' gestation were lower in the ketanserin group, and mean birthweight was significantly higher. INTERPRETATION: We found an association between the addition of ketanserin to aspirin and a decrease in the number of cases of pre-eclampsia and severe hypertension, as well as improved pregnancy outcome among patients with mild to moderate midtrimester hypertension.