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In the preparation of a randomised controlled trial to evaluate a new programme of antenatal care (ANC) in different parts of the world, we conducted a baseline survey of the ANC procedures in all 53 clinics participating in the trial. There were two components of this survey: (1) description of clinic characteristics and services offered: the staff of each clinic was interviewed and direct observation was made by field supervisors, and (2) the actual use of services by pregnant women attending these clinics: we reviewed a random sample of 2913 clinical histories. The clinical units surveyed were offering most of the activities, screening, laboratory tests and interventions recommended as effective according to the Cochrane Pregnancy and Childbirth Database (PCD), although some of these were not available in some sites. On the other hand, some tests and interventions that are considered not effective according to these criteria are reportedly offered. There was a difference across sites in the availability and offer to low-risk women of vaginal examination, evaluation of pelvic size, dental examination, external version for breech presentation and formal risk score classification, and a notable difference in the type of principal provider of ANC. There was a large variation in the actual use of screening and laboratory tests and interventions that should be offered to all women according to Cochrane PCD criteria: some of these are simply not available in a site; others are available, but only a fraction of women attending the clinics are receiving them. The participating sites all purport to follow the traditional ‘Western’ schedule for ANC, but in three sites we found that a high percentage of women initiate their ANC after the first trimester, and therefore do not have either the recommended minimum number of visits during pregnancy or the minimum first trimester evaluation. It is concluded that the variability and heterogeneity of ANC services provided in the four study sites are disturbing to the profession and cast doubts on the rationale of routine ANC. [ABSTRACT FROM AUTHOR]

The World Health Organisation and collaborating institutions in developing countries are conducting a multicentre randomised controlled trial to evaluate a new antenatal care (ANC) programme, consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. These activities are distributed, for practical reasons, over four visits during the course of pregnancy and are aimed at achieving predetermined goals. The study is taking place in four countries, Argentina, Cuba, Saudi Arabia and Thailand. Recruitment of study subjects started on 1 May 1996. All 53 ANC clinical units had been enrolled by December 1996. Clinics in each country were randomly allocated (cluster randomisation) to provide either the new programme or the traditional programme currently in use. Approximately 24 000 women presenting for ANC at these clinics over an average period of 18 months will have been recruited. As women attending the control clinics receive the ‘best standard treatment’ as currently offered in these clinics, individual informed consent is requested only from women attending the intervention clinics. Authorities of the corresponding health districts and all participating clinics have provided written institutional informed consent before randomisation. The primary outcome of the trial in relation to maternal conditions is the rate of a morbidity indicator index, defined as the presence of at least one of the following conditions for which ANC is relevant: (a) pre-eclampsia or eclampsia during pregnancy or within 24 h of delivery; (b) postpartum anaemia (haemoglobin < 90 g/L); or (c) severe urinary tract infection/pyelonephritis, defined as an episode requiring antibiotic treatment and/or hospitalisation. The primary fetal outcome is the rate of low birthweight (< 2500 g). Adverse maternal and fetal outcomes are expected for ≈ 10% of the control group. Several maternal and perinatal secondary outcomes are also considered. A comprehensive cost-effective-ness analysis and women's and providers’ satisfaction evaluation are performed concurrently with the trial. Health-care programmes should be rigorously evaluated by randomised controlled trials, which are feasible in developing countries and should be conducted before introducing new treatments or health interventions. [ABSTRACT FROM AUTHOR]

We discuss methodological issues arising in a recent evaluation trial of a new antenatal care programme, as sponsored by the Special Programme of Research, Development and Research Training in Human Reproduction, and WHO's Division of Reproductive Health (Technical Support). The randomisation unit for the trial is the antenatal care clinic, with 53 clinics located in four countries randomly allocated to provide either the new programme or the traditional programme currently in use. Approximately 24,000 women presenting for antenatal care over an average period of 18 months will have been recruited. [ABSTRACT FROM AUTHOR]

Background: We undertook a multicentre randomised controlled trial that compared the standard model of antenatal care with a new model that emphasises actions known to be effective in improving maternal or neonatal outcomes and has fewer clinic visits.Methods: Clinics in Argentina, Cuba, Saudi Arabia, and Thailand were randomly allocated to provide either the new model (27 clinics) or the standard model currently in use (26 clinics). All women presenting for antenatal care at these clinics over an average of 18 months were enrolled. Women enrolled in clinics offering the new model were classified on the basis of history of obstetric and clinical conditions. Those who did not require further specific assessment or treatment were offered the basic component of the new model, and those deemed at higher risk received the usual care for their conditions; however, all were included in the new-model group for the analyses, which were by intention to treat. The primary outcomes were low birthweight (<2500 g), pre-eclampsia/eclampsia, severe postpartum anaemia (<90 g/L haemoglobin), and treated urinary-tract infection. There was an assessment of quality of care and an economic evaluation.Findings: Women attending clinics assigned the new model (n=12568) had a median of five visits compared with eight within the standard model (n=11958). More women in the new model than in the standard model were referred to higher levels of care (13.4% vs 7.3%), but rates of hospital admission, diagnosis, and length of stay were similar. The groups had similar rates of low birthweight (new model 7.68% vs standard model 7.14%; stratified rate difference 0.96 [95% CI -0.01 to 1.92]), postpartum anaemia (7.59% vs 8.67%; 0.32), and urinary-tract infection (5.95% vs 7.41%; -0.42 [-1.65 to 0.80]). For pre-eclampsia/eclampsia the rate was slightly higher in the new model (1.69% vs 1.38%; 0.21 [-0.25 to 0.67]). Adjustment by several confounding variables did not modify this pattern. There were negligible differences between groups for several secondary outcomes. Women and providers in both groups were, in general, satisfied with the care received, although some women assigned the new model expressed concern about the timing of visits. There was no cost increase, and in some settings the new model decreased cost.Interpretations: Provision of routine antenatal care by the new model seems not to affect maternal and perinatal outcomes. It could be implemented without major resistance from women and providers and may reduce cost. [ABSTRACT FROM AUTHOR]

Background and Objectives: In view of the global increase in the rate of cesarean deliveries (CD), with the associated higher morbidity and mortality, this study was undertaken to review CD rates and some of their determinants over a ten-year period in Saudi Arabia. Methods: Maternity data for Ministry of Health (MOH) hospitals across 14 administrative regions and other governmental hospitals in nine clusters were collected and the corresponding rates calculated using MOH yearly statistical books from 1997 to 2006. No private hospital data are reported. Results: The overall CD rate significantly increased by 80.2% from 10.6% in 1997 to 19.1% in 2006. The greatest increase of 265% was in the Northern region and the least of 32.8% was in the Royal Commission Hospitals. Both vaginal breech and operative vaginal deliveries showed a significant decrease of 38% and 29%, respectively. There was a significant negative correlation between the increasing CD rate and the decreasing vaginal breech and operative vaginal deliveries rates. The volume of annual deliveries did not influence the CD rate. Conclusions: A significant increase of more than 80% in the CD rate was observed from 1997 to 2006. A national strategy to reduce the CD rate is needed and will require upgrading of the existing vital registration system. We also recommend that current national data capturing mechanisms be expanded to include private sector data and to include indications for CD.

Abstract Background The results of a qualitative study carried out in four developing countries (Cuba, Thailand, Saudi Arabia and Argentina) are presented. The study was conducted in the context of a randomised controlled trial to test the benefits of a new antenatal care protocol that reduced the number of visits to the doctor, rationalised the application of technology, and improved the provision of information to women in relation to the traditional protocol applied in each country. Methods Through focus groups discussions we were able to assess the concepts and expectations underlying women's evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries. Results Three areas are particularly addressed in this paper: a) concepts about pregnancy and health care, b) experience with health services and health providers, and c) opinions about the modified Antenatal Care (ANC) programme. In all three topics similarities were identified as well as particular opinions related to country specific social and cultural values. In general women have a positive view of the new ANC protocol, particularly regarding the information they receive. However, controversial issues emerged such as the reduction in the number of visits, particularly in Cuba where women are used to have 18 ANC visits in one pregnancy period. Conclusion Recommendations to improve ANC services performance are being proposed. Any country interested in the application of a new ANC protocol should regard the opinion and acceptability of women towards changes.

Abstract Background This study assessed women and providers' satisfaction with a new evidence-based antenatal care (ANC) model within the WHO randomized trial conducted in four developing countries. The WHO study was a randomized controlled trial that compared a new ANC model with the standard type offered in each country. The new model of ANC emphasized actions known to be effective in improving maternal or neonatal health, excluded other interventions that have not proved to be beneficial, and improved the information component, especially alerting pregnant women to potential health problems and instructing them on appropriate responses. These activities were distributed within four antenatal care visits for women that did not need any further assessment. Methods Satisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers. Results Most women in both arms expressed satisfaction with ANC. More women in the intervention arm were satisfied with information on labor, delivery, family planning, pregnancy complications and emergency procedures. More providers in the experimental clinics were worried about visit spacing, but more satisfied with the time spent and information provided. Conclusions Women and providers accepted the new ANC model generally. The safety of fewer visits for women without complications with longer spacing would have to be reinforced, if such a model is to be introduced into routine practice.

Objective: Preeclampsia, gestational hypertension, and unexplained intrauterine growth restriction may have similar determinants and consequences. In this study, we compared determinants and perinatal outcomes associated with these obstetric conditions., Study Design: We analyzed 39,615 pregnancies (data from the WHO Antenatal Care Trial), of which 2.2% were complicated by preeclampsia, 7.0% by gestational hypertension, and 8.1% by unexplained intrauterine growth restriction (ie, not associated with maternal smoking, maternal undernutrition, preeclampsia, gestational hypertension, or congenital malformations). We compared the risk factors associated with these groups. Fetal death, preterm delivery, and severe neonatal morbidity and mortality were the primary outcomes. Logistic regression analyses were adjusted for study site, socioeconomic status, and (if appropriate) birth weight and gestational age., Results: Diabetes, renal or cardiac disease, previous preeclampsia, urinary tract infection, high maternal age, twin pregnancy, and obesity increased the risk of both hypertensive conditions. Previous large-for-age birth, reproductive tract surgery, antepartum hemorrhage and reproductive tract infection increased the risk for gestational hypertension only. Independent of maternal age, primiparity was a risk factor only for preeclampsia. Both preeclampsia and gestational hypertension were associated with increased risk for fetal death and severe neonatal morbidity and mortality. Mothers with preeclampsia compared with those with unexplained intrauterine growth restriction were more likely to have a history of diabetes, renal or cardiac disease, chronic hypertension, previous preeclampsia, body mass index more than 30 kg/cm2, urinary tract infection and extremes of maternal age. Conversely, unexplained intrauterine growth restriction was associated with higher risk of low birth weight in previous pregnancies, but not with previous preeclampsia. Both conditions increased the risk for perinatal outcomes independently but preeclampsia was associated with considerable higher risk., Conclusion: Preeclampsia and gestational hypertension shared many risk factors, although there are differences that need further evaluation. Both conditions significantly increased morbidity and mortality. Conversely, preeclampsia and unexplained intrauterine growth restriction, often assumed to be related to placental insufficiency, seem to be independent biologic entities.

Background: To identify the risk factors for failed instrumental vaginal delivery, and to compare maternal and neonatal morbidity associated with failed individual and sequential instruments used., Design: A retrospective case-control study., Methods: From January 1995 to June 2001, there were 39 508 live births at >37 weeks' gestation of which 2628 (6.7%) instrumental vaginal deliveries were performed, 1723 (4.4%) were vacuum extractions and 905 (2.3%) were forceps. A total of 155/2628 (5.9%) patients who had failed instrumental delivery were matched with 204 patients who had successful instrumental delivery. The patients were divided into five groups. Group I (n = 129) had failed vacuum extraction, group II (n = 13) failed forceps, group III (n = 13) failed both (i.e. failed attempt at both instruments sequentially), group IV (n = 138) had successful vacuum extraction and group V (n = 66) successful forceps., Results: The failure rate for vacuum extractions 129/1723 (7.5%) was significantly higher than that for forceps 13/905 (1.4%) [odds ratio (OR) = 5.6, 95% CI 3-10.3]. There were no significant differences in all maternal complications (25.5% vs. 26.6%) between vacuum (groups I and IV) and forceps (groups II and V) assisted deliveries. There were more maternal complications in group III (46.2%) than in groups I (35.7%), II (23.1%) and V (27.3%) that did not reach statistical significance but were significantly higher than in group IV (15.9%, OR = 4.5, 95% CI 1.2-16.9). There was a significantly higher rate of all fetal complications in group III [11/13 (84.6%)] than in groups I [69/129 (53.5%)], II [7/13 (53.8%)], IV [35/138 (25.4%)] and V [22/66 (33.3%)] (OR = 4.8, 95% CI 0.9-19.9)., Conclusions: Applying the instrument at < or =0 fetal station, nulliparous women, history of previous cesarean section and fetal head other than occipitoanterior position were risk factors for failed instrumental delivery. Sequential use of instrumental delivery carries a significantly higher neonatal morbidity than when a single instrument is used.

Background: The results of a qualitative study carried out in four developing countries (Cuba, Thailand, Saudi Arabia and Argentina) are presented. The study was conducted in the context of a randomised controlled trial to test the benefits of a new antenatal care protocol that reduced the number of visits to the doctor, rationalised the application of technology, and improved the provision of information to women in relation to the traditional protocol applied in each country., Methods: Through focus groups discussions we were able to assess the concepts and expectations underlying women's evaluation of concepts and experiences of the care received in antenatal care clinics. 164 women participated in 24 focus groups discussion in all countries., Results: Three areas are particularly addressed in this paper: a) concepts about pregnancy and health care, b) experience with health services and health providers, and c) opinions about the modified Antenatal Care (ANC) programme. In all three topics similarities were identified as well as particular opinions related to country specific social and cultural values. In general women have a positive view of the new ANC protocol, particularly regarding the information they receive. However, controversial issues emerged such as the reduction in the number of visits, particularly in Cuba where women are used to have 18 ANC visits in one pregnancy period., Conclusion: Recommendations to improve ANC services performance are being proposed. Any country interested in the application of a new ANC protocol should regard the opinion and acceptability of women towards changes.

BACKGROUND: This study assessed women and providers' satisfaction with a new evidence-based antenatal care (ANC) model within the WHO randomized trial conducted in four developing countries. The WHO study was a randomized controlled trial that compared a new ANC model with the standard type offered in each country. The new model of ANC emphasized actions known to be effective in improving maternal or neonatal health, excluded other interventions that have not proved to be beneficial, and improved the information component, especially alerting pregnant women to potential health problems and instructing them on appropriate responses. These activities were distributed within four antenatal care visits for women that did not need any further assessment. METHODS: Satisfaction was measured through a standardized questionnaire administered to a random sample of 1,600 pregnant women and another to all antenatal care providers. RESULTS: Most women in both arms expressed satisfaction with ANC. More women in the intervention arm were satisfied with information on labor, delivery, family planning, pregnancy complications and emergency procedures. More providers in the experimental clinics were worried about visit spacing, but more satisfied with the time spent and information provided. CONCLUSIONS: Women and providers accepted the new ANC model generally. The safety of fewer visits for women without complications with longer spacing would have to be reinforced, if such a model is to be introduced into routine practice.

Objective: To document the occurrence of long-term sequelae after type I female genital mutilation (FGM) and describe the surgical treatment of epidermal clitoral inclusion cyst., Study Design: Twenty-one women presented with epidermal clitoral inclusion cyst after type I FGM at the Department of Obstetrics and Gynecology at King Fahad Armed Forces Hospital, Jeddah, Saudi Arabia. The duration (mean +/- SD, range) of symptoms was 10.3 +/- 5.4, 2 to 20 years. They were treated by excision of the cyst with particular attention to preserve the remaining part of the clitoris. The technique involves making a vertical incision in the skin, dissecting and excising the cyst, removing the excessive skin, and reapproximating the skin edges., Results: The procedure was done on all patients without intraoperative complications. All except one were discharged home on the second postoperative day. Follow-up showed no recurrence of symptoms., Conclusion: Long-term sequelae can occur after type I FGM. The surgical treatment of clitoral inclusion cyst is simple and effective.

The World Health Organization and collaborating institutions in four developing countries have conducted a multi-centre randomized controlled trial, in which clinics were allocated at random to two antenatal care (ANC) models. These were the standard 'Western' ANC model and a 'new' ANC model consisting of tests, clinical procedures and follow-up actions scientifically demonstrated to be effective in improving maternal and newborn outcomes. The two models were compared using the equivalence approach. This paper discusses the implications of the equivalence approach in the sample size calculation, analysis and interpretation of results of this cluster randomized trial. It reviews the ethical aspects regarding informed consent, concluding that the Zelen design has a place in cluster randomization trials. It describes the estimation of the intracluster correlation coefficient (ICC) in a stratified cluster randomized trial using two methods and reports estimates of the ICC obtained for many maternal, newborn and perinatal outcomes. Finally, it discusses analytical problems that arose: issues encountered using a composite index, heterogeneity of the intervention effect across sites, the choice of the method of analysis and the importance of efficacy analyses. The choice of the clustered Woolf estimator and the generalized estimating equations (GEE) as the methods of analysis applied is discussed., (Copyright 2001 John Wiley & Sons, Ltd.)

In a clinical study from an unselected Saudi obstetric population, the incidence of and risk factors for intrauterine growth retardation among live births were investigated. From a total study group of 4578 consecutive live births, 76 (1.7%) infants were found to be growth retarded. These infants were then compared with a randomly selected control group of 76 term newborns with appropriate birthweight for their gestational ages. Delivery at term of a growth-retarded infant was significantly associated with maternal age under 20 years, maternal body mass index less than 23, first degree consanguinity, poor housing, primiparity, and inadequate prenatal care in univariate analysis. When considered jointly in multivariate logistic regression analysis, the significant determinants were reduced to primiparity, first degree consanguinity, and poor housing. These risk factors correctly predicted 63% and 71% of the intrauterine growth-retarded infants or normal birthweight infants, respectively.

Preterm birth (< 37 weeks completed gestation), the primary predictor of infant morbidity and mortality, can result from diverse biologic and sociodemographic variables. A case-control study was undertaken to determine risk factors that were significantly associated with preterm birth in our population. Pertinent data were collected by structured interviews with eligible subjects and by medical record abstraction. The study population consisted of 118 mothers of singleton, preterm, appropriate for gestational age infants (cases) and 118 mothers of singleton, term, appropriate for gestational age infants (controls). A multiple logistic regression analysis indicated that significant risk factors for preterm birth were first or second trimester vaginal bleeding during current pregnancy, a previous preterm birth, inadequate prenatal care, consanguinity, maternal body mass index of < 23, and short inter-pregnancy interval. Awareness of such risk factors is essential in planning public education programs and in considering appropriate perinatal care options for women at potentially higher risk for preterm delivery.

Two hundred and seventy seven Saudi women were prospectively evaluated post-partum to determine the frequency of post-partum thyroiditis. Four to six weeks after delivery, 12 (4.3%) had positive antimicrosomal antibodies and 8 (2.9%) had positive antithyroglobulin antibodies. At 6-8 weeks post-partum, out of 82 subjects followed up, 4 (4.9%) had positive antimicrosoMal antibodies and 1 (1.2%) had positive antithyroglobulin antibodies. At 8-12 weeks post-partum, out of 70 subjects, antimicrosomal antibodies were detected in 5 (3.5%) subjects and antithyroglobulin in 2 (1.4%). Their routine thyroid function tests (T3, T4, and TSH) remained within the normal range. There was no clinical evidence of hyper- or hypothyroidism in any of the patients during the follow up. Post-partum thyroiditis, appears to be relatively uncommon in Saudi Arabia. It does not produce any clinical illness or cause significant subclinical thyroid dysfunction.

In a multicentre prospective study, we have determined the incidence of low birthweight (LBW) and the main predisposing risk factors. Among 4651 consecutive births over a 5-month period in five hospitals in Riyadh, the overall incidence of LBW was 8.4%. When stillbirths were excluded the incidence of LBW was 7.4% of all live births. Statistical analysis was performed among 638 births (319 LBW infants, i.e. less than or equal to 2499 g and 319 babies weighing 2500 g or more). Of the 28 antenatal risk variables analysed, 13 were found to be significant when studied separately. Of these 13 variables, six were found to be significant predictors of LBW, using stepwise multiple logistic regression. These six variables together correctly predicted 72% and 88% of the LBW babies or normal birthweight babies, respectively. The risk factors thus identified were (i) short gestation, (ii) multiple gestation, (iii) low maternal body mass index, (iv) nulliparity, (v) availability of housework help, and (vi) absence of consanguinity. Measures for reducing these factors are also discussed.