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Biomedical subjects

A M Gülmezoglu

Publications and source records attributed to A M Gülmezoglu.

At least 19 recordsLinked to original sources
PubMed2006

Drugs for preventing malaria in pregnant women.

BACKGROUND: Malaria contributes to maternal illness and anaemia in pregnancy, especially in first-time mothers, and can harm the mother and the baby. Drugs given routinely to prevent or mitigate the effects of malaria during pregnancy are often recommended. OBJECTIVES: To assess drugs given to prevent malaria infection and its consequences in pregnant women living in malarial areas. This includes prophylaxis and intermittent preventive treatment (IPT). SEARCH STRATEGY: We searched the Cochrane Infectious Diseases Group Specialized Register (March 2006), CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to March 2006), EMBASE (1974 to March 2006), LILACS (1982 to March 2006), and reference lists. We also contacted researchers working in the field. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials comparing antimalarial drugs given regularly with no antimalarial drugs for preventing malaria in pregnant women living in malaria-endemic areas. DATA COLLECTION AND ANALYSIS: Both authors extracted data and assessed methodological quality. Dichotomous variables were combined using relative risks (RR) and weighted mean differences (WMD) for mean values, both with 95% confidence intervals (CI). MAIN RESULTS: Sixteen trials (12,638 participants) met the inclusion criteria; two used adequate methods to conceal allocation. Antimalarials reduced antenatal parasitaemia when given to all pregnant women (RR 0.53, 95% CI 0.33 to 0.86; 328 participants, 2 trials), placental malaria (RR 0.34, 95% CI 0.26 to 0.45; 1236 participants, 3 trials), but no effect was detected with perinatal deaths (2890 participants, 4 trials). In women in their first or second pregnancy, antimalarial drugs reduced severe antenatal anaemia (RR 0.62, 95% CI 0.50 to 0.78; 2809 participants, 1 prophylaxis and 2 IPT trials), antenatal parasitaemia (RR 0.27, 95% CI 0.17 to 0.44, random-effects model; 2906 participants, 6 trials), and perinatal deaths (RR 0.73, 95% CI 0.53 to 0.99; 1986 participants, 2 prophylaxis and 1 IPT trial; mean birthweight was higher (WMD 126.70 g, 95% CI 88.64 to 164.75 g; 2648 participants, 8 trials), and low birthweight less frequent (RR 0.57, 95% CI 0.46 to 0.72; 2350 participants, 6 trials). Proguanil performed better than chloroquine in one trial of women of all parities in relation to maternal fever episodes. Sulfadoxine-pyrimethamine performed better than chloroquine in two trials of low-parity women. AUTHORS' CONCLUSIONS: Chemoprophylaxis or IPT reduces antenatal parasite prevalence and placental malaria when given to women in all parity groups. They also have positive effects on birthweight and possibly on perinatal death in low-parity women.

Antimalarials↗
PubMed2006

Induction of labour for improving birth outcomes for women at or beyond term.

BACKGROUND: As a pregnancy continues beyond term the risks of babies dying inside the womb or in the immediate newborn period increase. Whether a policy of labour induction at a predetermined gestational age can reduce this increased risk is the subject of this review. OBJECTIVES: To evaluate the benefits and harms of a policy of labour induction at term or post-term compared to awaiting spontaneous labour or later induction of labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (June 2006). SELECTION CRITERIA: Randomized controlled trials conducted in women at or beyond term. The eligible trials were those comparing a policy of labour induction to a policy of awaiting spontaneous onset of labour. Trials comparing cervical ripening methods, membrane stripping/sweeping or nipple stimulation without any commitment to delivery within a certain time were excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated potentially eligible trials and extracted data. Outcomes are analysed in two main categories: gestational age and cervix status. MAIN RESULTS: We included 19 trials reporting on 7984 women. A policy of labour induction at 41 completed weeks or beyond was associated with fewer (all-cause) perinatal deaths (1/2986 versus 9/2953; relative risk (RR) 0.30; 95% confidence interval (CI) 0.09 to 0.99). The risk difference is 0.00 (95% CI 0.01 to 0.00). If deaths due to congenital abnormality are excluded, no deaths remain in the labour induction group and seven deaths remain in the no-induction group. There was no evidence of a statistically significant difference in the risk of caesarean section (RR 0.92; 95% CI 0.76 to 1.12; RR 0.97; 95% CI 0.72 to 1.31) for women induced at 41 and 42 completed weeks respectively. Women induced at 37 to 40 completed weeks were more likely to have a caesarean section with expectant management than those in the labour induction group (RR 0.58; 95% CI 0.34 to 0.99). There were fewer babies with meconium aspiration syndrome (41+: RR 0.29; 95% CI 0.12 to 0.68, four trials, 1325 women; 42+: RR 0.66; 95% CI 0.24 to 1.81, two trials, 388 women). AUTHORS' CONCLUSIONS: A policy of labour induction after 41 completed weeks or later compared to awaiting spontaneous labour either indefinitely or at least one week is associated with fewer perinatal deaths. However, the absolute risk is extremely small. Women should be appropriately counselled on both the relative and absolute risks.

Cesarean Section↗
PubMed2006

Cluster randomised trial of an active, multifaceted educational intervention based on the WHO Reproductive Health Library to improve obstetric practices.

OBJECTIVE: We conducted a trial to evaluate the effect of an active, multifaceted educational strategy to promote the use of the WHO Reproductive Health Library (RHL) on obstetric practices. DESIGN: Cluster randomised trial. The trial was assigned the International Standardised Randomised Controlled Trial Number ISRCTN14055385. SETTINGS: Twenty-two hospitals in Mexico City and 18 in the Northeast region of Thailand. METHODS: The intervention consisted primarily of three interactive workshops using RHL over a period of 6 months. The focus of the workshops was to provide access to knowledge and enable its use. A computer and support for using both the computer and RHL were provided at each hospital. The control hospitals did not receive any intervention. MAIN OUTCOME MEASURES: The main outcome measures were changes in ten selected clinical practices as recommended in RHL starting approximately four to six months after the third workshop. Clinical practice data were collected at each hospital from 1000 consecutively delivered women or for a 6-month period whichever was reached sooner. RESULTS: The active, multifaceted educational intervention we employed did not affect the ten targeted practices in a consistent and substantive way. Iron/folate supplementation, uterotonic use after birth and breastfeeding on demand were already frequently practiced, and we were unable to measure external cephalic version. Of the remaining six practices, selective, as opposed to routine episiotomy policy increased in the intervention group (difference in adjusted mean rate = 5.3%; 95% CI -0.1 to 10.7%) in Thailand, and there was a trend towards an increased use of antibiotics at caesarean section in Mexico (difference in adjusted mean rate = 19.0%; 95% CI: -8.0 to 46.0%). There were no differences in the use of labour companionship, magnesium sulphate use for eclampsia, corticosteroids for women delivering before 34 weeks and vacuum extraction. RHL awareness (24.8-65.5% in Mexico and 33.9-83.3% in Thailand) and use (4.8-34.9% in Mexico and 15.5-76.4% in Thailand) increased substantially after the intervention in both countries. CONCLUSION: The multifaceted, active strategy to provide health workers with the knowledge and skills to use RHL to improve their practice led to increased access to and use of RHL, however, no consistent or substantive changes in clinical practices were detected within 4-6 months after the third workshop.

Clinical Competence↗
PubMed2004

Prostaglandins for prevention of postpartum haemorrhage.

BACKGROUND: Prostaglandins have mainly been used for postpartum haemorrhage when other measures fail. Misoprostol, a new and inexpensive prostaglandin E1 analogue, has been suggested as an alternative for routine management of the third stage of labour. OBJECTIVES: To assess the effects of prophylactic prostaglandin use in the third stage of labour. SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register (March 2003). SELECTION CRITERIA: Randomized or quasi-randomized trials comparing a prostaglandin agent with another uterotonic or no prophylactic uterotonic (nothing or placebo) as part of management of the third stage of labour. There were no language preferences. DATA COLLECTION AND ANALYSIS: Eligibility, trial quality and data extraction were done by two reviewers independently. MAIN RESULTS: Twenty-four misoprostol and eight intramuscular prostaglandin trials (34,203 participants) were included. The data comparing oral misoprostol to no uterotonics/placebo are from five trials and difficult to interpret because of the heterogeneity between trials. However, the data do not suggest a substantive reduction in the rate of postpartum haemorrhage or other measures of blood loss. Oral misoprostol 600 mcg shows clinically and statistically significantly more blood loss = 1000 ml compared with conventional injectable uterotonics (seven trials, 22,749 women, 3.6% versus 2.7%; relative risk (RR) 1.34, 95% confidence interval (CI) 1.16 to 1.55). Shivering and elevated body temperature (> 38 masculine C) are the main side-effects of misoprostol and are dose related (600 mcg versus 400 mcg: shivering - two trials, RR: 1.33; 95% CI: 1.07 to 1.64). Compared to oxytocin the RR of any shivering with 600 mcg oral misoprostol is 3.29 (seven trials, 22746 women; 19.7% versus 6.0%, 95% CI 3.03 to 3.56) and temperature greater than 38 masculine C is RR 6.78 (seven trials, 22,09 women; 6.3% versus, 95% CI 5.55 to 8.30). Injectable prostaglandins are associated with reduced mean blood loss in the third stage of labour (weighted mean difference -70 ml, 95% CI -73 to -67 ml) when compared to conventional injectable uterotonics but have more side-effects. There are scarce data from this comparison on severe postpartum haemorrhage and the use of additional uterotonics, the primary outcomes of this review. REVIEWER'S CONCLUSIONS: Neither intramuscular prostaglandins nor misoprostol are preferable to conventional injectable uterotonics as part of the active management of the third stage of labour especially for low-risk women. Future research on prostaglandin use after birth should focus on the treatment of postpartum haemorrhage rather than prevention where they seem to be more promising.

Female↗
PubMed2004

Interventions for emergency contraception.

BACKGROUND: In emergency contraception a drug or IUD is used to prevent pregnancy shortly after unprotected intercourse. Except for some Western-European countries and China, emergency contraception is largely under-utilised worldwide. In many developing countries lack of access to emergency contraception may subject women to unsafe abortions, which contribute significantly to maternal mortality and morbidity. Currently, several interventions (IUD, the Yuzpe regimen, levonorgestrel, mifepristone, danazol and some combination regimens) are available for emergency contraception. Information on the comparative efficacy, safety and convenience of these methods is crucial for reproductive health care providers and the women they serve. OBJECTIVES: To determine which emergency contraceptive method following unprotected intercourse is the most effective, safe and convenient to prevent pregnancy. SEARCH STRATEGY: The search included the Cochrane Controlled Trials Register, Popline, MEDLINE, Chinese biomedical databases and UNDP/UNFPA/WHO/World Bank Special Programme on Human Reproduction (HRP) emergency contraception database (July 2003). Content experts and pharmaceutical companies were contacted. SELECTION CRITERIA: Randomised controlled trials and controlled clinical trials including women attending services for emergency contraception following a single act of unprotected intercourse were eligible. DATA COLLECTION AND ANALYSIS: Data on outcomes and trial characteristics were extracted in duplicate and independently by two reviewers. Quality assessment was also done by two reviewers independently. Meta-analysis results are expressed as relative risk (RR) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity a random-effect model was applied. MAIN RESULTS: Forty-eight trials with 33110 women were included. Most trials were conducted in China (37/48). Levonorgestrel is more effective than the Yuzpe regimen in preventing pregnancy (2 trials, RR: 0.51; 95% CI: 0.31 to 0.83). Single dose (1.5 mg) administration seems to have similar effectiveness as the standard 12 hours apart split-dose (0.75 mg twice) of levonorgestrel (2 trials, RR: 0.77, 95% CI: 0.45 to 1.30). Levonorgestrel has similar effectiveness to mid-dose (8 trials, RR: 1.64; 95% CI: 0.82 to 3.25) or low-dose (7 trials, RR: 1.38; 95% CI: 0.93 to 2.05) mifepristone. Low-dose (=< 10 mg) mifepristone is similarly effective as mid doses (25-50 mg) when only high quality trials are considered. Delay in the onset of subsequent menses is the main unwanted effect of mifepristone and seems to be dose-related. The Yuzpe regimen can be used when levonorgestrel and mifepristone are not available. Half-dose Yuzpe with single administration is associated with fewer side-effects but it is not clear whether it is as effective as the standard Yuzpe regimen (RR: 1.41; 95% CI: 0.76 to 2.61). REVIEWERS' CONCLUSIONS: Levonorgestrel 1.5 mg (two split doses or a single dose) and low and mid-doses (25-50 mg) of mifepristone offer high efficacy with an acceptable side-effect profile. Single dose simplifies the use of levonorgestrel for emergency contraception without an increase in side-effects. However, mifepristone might delay the following menstruation, which could increase anxiety, particularly in higher doses. The Yuzpe regimen could be used if levonorgestrel or mifepristone are not available. The intrauterine device (IUD) is another effective emergency contraceptive, and can be kept for ongoing contraception.

Contraception, Postcoital↗
PubMed2004

Medical methods for first trimester abortion.

BACKGROUND: Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins. OBJECTIVES: To compare different medical methods for first trimester abortion. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Types of studies. Randomised controlled trials comparing different medical methods (e.g. single drug, combination), ways of application, or different dose regimens, single or combined, for medical abortion, were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant in the first trimester, undergoing medical abortion were the participants. Different medical methods used for first trimester abortion, compared with each other or placebo were included. The outcomes sought include mortality, failure to achieve complete abortion, surgical evacuation (as emergency procedure, non-emergency procedure, or undefined), ongoing pregnancy at follow-up, time until passing of conceptus (> 3-6 hours), blood transfusion, blood loss (measured or clinically relevant drop in haemoglobin), days of bleeding, pain resulting from the procedure (reported by the women or measured by use of analgesics), additional uterotonics used, women's dissatisfaction with the procedure, nausea, vomiting, diarrhoea. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion from the results of the search strategy described previously. The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. A form was designed to facilitate the data extraction. Data were processed using Revman software. MAIN RESULTS: Thirty-nine trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. 2) Mifepristone alone is less effective compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Similarly, the 5 trials included in the comparison of prostaglandin compared to the combined regimen reported in all but one higher effectiveness with the combined regime compared to prostaglandin. The results of these studies were not pooled but the RR of failure with prostaglandin alone is between 1.4 to 3.75 and the 95% confidence intervals indicate statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference when using split dose compared to single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin: there was no statistically significant difference in failure to achieve complete abortion comparing methotrexate administered intramuscular to oral (RR 2.04, 95% CI 0.51 to 8.07). Similarly, early (day 3) vs late (day 5) administration of prostaglandin showed no significant of prostaglandin showed no significant difference (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs methotrexate and no statistically significant differences were observed in effectiveness between the groups. REVIEWER'S CONCLUSIONS: Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Misoprostol vaginally is more effective than orally. Some of the results are based on small studies only and therefore carry some uncertainty. Almost all trials were conducted in hospital settings with good access to support and emergency services. It is therefore not clear if the results are readily applicable to under-resourced settings where such services are lacking even if the agents used are available.

Abortifacient Agents↗
PubMed2004

Medical methods for first trimester abortion.

BACKGROUND: Surgical abortion up to 63 days by vacuum aspiration or dilatation and curettage has been the method of choice since the 1960s. Medical abortion became an alternative method of first trimester pregnancy termination with the availability of prostaglandins in the early 1970s and anti-progesterones in the 1980s. The most widely researched drugs are prostaglandins (PGs) alone, mifepristone alone, methotrexate alone, mifepristone with prostaglandins and methotrexate with prostaglandins. OBJECTIVES: To compare different medical methods for first trimester abortion. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE and Popline were systematically searched. Reference lists of retrieved papers were also searched. Experts in WHO/HRP were contacted. SELECTION CRITERIA: Types of studies. Randomised controlled trials comparing different medical methods (e.g. single drug, combination), ways of application, or different dose regimens, single or combined, for medical abortion, were considered. Trials were assessed and included if they had adequate concealment of allocation, randomisation procedure and follow-up. Women, pregnant in the first trimester, undergoing medical abortion were the participants. Different medical methods used for first trimester abortion, compared with each other or placebo were included. The outcomes sought include mortality, failure to achieve complete abortion, surgical evacuation (as emergency procedure, non-emergency procedure, or undefined), ongoing pregnancy at follow-up, time until passing of conceptus (> 3-6 hours), blood transfusion, blood loss (measured or clinically relevant drop in haemoglobin), days of bleeding, pain resulting from the procedure (reported by the women or measured by use of analgesics), additional uterotonics used, women's dissatisfaction with the procedure, nausea, vomiting, diarrhoea. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion from the results of the search strategy described previously. The selection of trials for inclusion in the review was performed independently by two reviewers after employing the search strategy described previously. Trials under consideration were evaluated for appropriateness for inclusion and methodological quality without consideration of their results. A form was designed to facilitate the data extraction. Data were processed using Revman software. MAIN RESULTS: Thirty-nine trials were included in the review. The effectiveness outcomes below refer to 'failure to achieve complete abortion' with the intended method unless otherwise stated. 1) Combined regimen mifepristone/prostaglandin: Mifepristone 600 mg compared to 200 mg shows similar effectiveness in achieving complete abortion (4 trials, RR 1.07, 95% CI 0.87 to 1.32). Misoprostol administered orally is less effective (more failures) than the vaginal route (RR 3.00, 95% CI 1.44 to 6.24) and may be associated with more frequent side effects such as nausea and diarrhoea. 2) Mifepristone alone is less effective compared to the combined regimen mifepristone/prostaglandin (RR 3.76 95% CI 2.30 to 6.15). 3) Similarly, the 5 trials included in the comparison of prostaglandin compared to the combined regimen reported in all but one higher effectiveness with the combined regime compared to prostaglandin. The results of these studies were not pooled but the RR of failure with prostaglandin alone is between 1.4 to 3.75 and the 95% confidence intervals indicate statistical significance. 4) In one trial comparing gemeprost 0.5 mg with misoprostol 800 mcg, misoprostol was more effective (failure with gemeprost: RR 2.86, 95% CI 1.14 to 7.18). 5) There was no difference when using split dose compared to single dose of prostaglandin. 6) Combined regimen methotrexate/prostaglandin: there was no statistically significant difference in failure to achieve complete abortion comparing methotrexate administered intramuscular to oral (RR 2.04, 95% CI 0.51 to 8.07). Similarly, early (day 3) vs late (day 5) administration of prostaglandin showed no significant of prostaglandin showed no significant difference (RR 0.72, 95% CI 0.36 to 1.43). One trial compared the effect of tamoxifen vs methotrexate and no statistically significant differences were observed in effectiveness between the groups. REVIEWERS' CONCLUSIONS: Safe and effective medical abortion methods are available. Combined regimens are more effective than single agents. In the combined regimen, the dose of mifepristone can be lowered to 200 mg without significantly decreasing the method effectiveness. Misoprostol vaginally is more effective than orally. Some of the results are based on small studies only and therefore carry some uncertainty. Almost all trials were conducted in hospital settings with good access to support and emergency services. It is therefore not clear if the results are readily applicable to under-resourced settings where such services are lacking even if the agents used are available.

Abortifacient Agents↗
PubMed2004

Progestogens in combined oral contraceptives for contraception.

BACKGROUND: The progestogen component of oral contraceptives (OC) has undergone changes since it was first recognised that their chemical structures could influence the spectrum of minor adverse and beneficial effects. The major determinants of OCs are effectiveness, cycle control and common side effects. The rationale of this review is to provide a systematic comparison of OCs containing the progestogens currently in use worldwide. OBJECTIVES: The objective of this review is to compare currently available low-dose OCs containing ethinyl estradiol and different progestogens in terms of contraceptive effectiveness, cycle control, side effects and continuation rates. SEARCH STRATEGY: The Cochrane Controlled Trials Register, MEDLINE and EMBASE databases have been searched systematically. Relevant pharmaceutical companies and the authors of articles included in this review have been contacted for clarification. SELECTION CRITERIA: Randomised trials reporting clinical outcomes were considered for inclusion. We excluded studies comparing mono- with multiphasic pills, and crossover trials with trials in which the difference in total content of ethinyl estradiol between preparations exceeded 105 micro g. DATA COLLECTION AND ANALYSIS: The methodological quality and validity of studies were assessed based on the above-mentioned inclusion criteria. Both application of inclusion criteria and data extraction were performed independently by the reviewers. Results are expressed as relative risk (RR) with 95% confidence interval (CI) using a random-effects model. MAIN RESULTS: Twenty-two trials have been included in this review, thus generating 14 comparisons. Eighteen trials were sponsored by pharmaceutical companies and in only 5 cases had a blind trial been attempted. Most comparisons between different interventions included 1-3 trials. There was less discontinuation with second- compared to first-generation progestogens (RR: 0.79, 95% CI: 0.69-0.91). Cycle control appears to be better when using second- compared to first-generation progestogens for both mono- (RR: 0.69; 95% CI: 0.52-0.91) and triphasic (RR: 0.61; 95% CI: 0.43-0.85) preparations.Contraceptive effectiveness, spotting, breakthrough bleeding and the absence of withdrawal bleeding was similar when using GSD compared to LNG, although there was less intermenstrual bleeding in the GSD group (RR: 0.71, 95% CI: 0.55, 0.91). Drospirenone (DRSP) appeared to be similar to DSG. REVIEWERS' CONCLUSIONS: Based on data from one trial, compared to pills containing LNG, those containing GSD may be associated with less intermenstrual bleeding although they show similar patterns of spotting, breakthrough bleeding and the absence of withdrawal bleeds. GSD is also comparable to DSG. Regarding acceptability, all the indices show that third- and second-generation progestogens are preferred over first-generation preparations. Future research should focus on independently conducted, well-designed randomised trials that compare third- and second-generation progestogens in particular.

Contraception↗
PubMed2002

Vitamin A supplementation during pregnancy.

BACKGROUND: Vitamin A supplements have been recommended in pregnancy to improve outcomes that include maternal mortality and morbidity. OBJECTIVES: To review the effectiveness of vitamin A supplementation during pregnancy, alone or in combination with other supplements, on maternal and newborn clinical and laboratory outcomes. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's specialised register of controlled trials (April 2002) and the Cochrane Controlled Trials Register (The Cochrane Library Issue 1, 2002). SELECTION CRITERIA: All randomised or quasi-randomised trials evaluating the effect of vitamin A supplementation in pregnant women. The types of intervention included vitamin A supplementation alone or in combination with other micro-nutrients. DATA COLLECTION AND ANALYSIS: We assessed trials for methodological quality using the standard Cochrane criteria of adequacy of concealment. At least two reviewers independently assessed the trials for inclusion and extracted data. We collected information on blinding, loss to follow-up, setting, number of women, exclusion after randomisation and follow-up as well as supplementation type, dose and frequency. The outcomes we sought included maternal and neonatal clinical and laboratory outcomes. MAIN RESULTS: Five trials involving 23,426 women were included. Because the trials were heterogeneous with regard to type of supplement given, duration of supplement use and outcomes measured, pooled results using meta analysis could not be performed. One large population based trial in Nepal showed a possible beneficial effect on maternal mortality after weekly vitamin A supplements. In this study a reduction was noted in all cause maternal mortality up to 12 weeks postpartum with Vitamin A supplementation (RR 0.60, 95% CI 0.37-0.97). Night-blindness was assessed in a nested case-control study within this trial and found to be reduced but not eliminated. Three trials examined the effect of vitamin A supplementation on haemoglobin levels. The trial from Indonesia showed a beneficial effect in women who were anaemic ([Hb] <11.0 g/dl). After supplementation, the proportion of women who became non-anaemic was 35% in the Vitamin A supplemented group, 68% in the iron-supplemented group, 97% in the group supplemented with both Vitamin A and iron and 16% in the placebo group. The two trials from Malawi did not corroborate these positive findings. REVIEWER'S CONCLUSIONS: Although the two trials from Nepal and Indonesia suggested beneficial effects of vitamin A supplementation, further trials are needed to determine whether vitamin A supplements can reduce maternal mortality and morbidity and by what mechanism.

Dietary Supplements↗
PubMed2002

Magnesium sulfate compared with lytic cocktail for women with eclampsia.

OBJECTIVE: To compare magnesium sulfate with lytic cocktail for the treatment of eclampsia. METHODS: The register of trials kept by the Cochrane Pregnancy and Childbirth Group and the Cochrane Controlled Trials Register were searched for randomized trials comparing magnesium sulfate with lytic cocktail for the treatment of eclampsia. RESULTS: Two studies were included (a total of 199 women). Magnesium sulfate was more effective than lytic cocktail at preventing further convulsions [relative risk (RR) 0.09, 95% confidence interval (C.I.)=0.03-0.24; risk difference=0.43, 95% C.I.=-0.53 to -0.34; number needed to treat=3, 95% C.I.=2-3) and was associated with less respiratory depression (RR=0.12, 95% C.I.=0.02-0.91) and fewer baby deaths (RR=0.26, 95% C.I.=0.26-0.79). There were non-significantly fewer maternal deaths associated with magnesium sulfate (RR=0.25, 95% C.I.=0.04-1.43). CONCLUSIONS: Magnesium sulfate is the anticonvulsant of choice for eclampsia. Lytic cocktail should be abandoned.

Anticonvulsants↗
PubMed2002

Systematic review of randomized controlled trials of misoprostol to prevent postpartum hemorrhage.

OBJECTIVE: To assess the effects of prophylactic misoprostol use in the third stage of labor compared with injectable uterotonics or placebo or no treatment. DATA SOURCES: The Cochrane Pregnancy and Childbirth Group trials register; the Cochrane Library, including databases such as the database of systematic reviews and the Cochrane Controlled Trials Register; and MEDLINE were searched. Researchers in the field were also contacted. The date of the latest search was March 1, 2002. METHODS OF STUDY SELECTION: Randomized trials comparing misoprostol with injectable oxytocin or oxytocin-ergot preparations to prevent postpartum hemorrhage or placebo/no treatment as active management of the third stage of labor were eligible for inclusion. Eligibility and trial quality were assessed following selected criteria. Data were extracted and analyzed using RevMan software. TABULATION, INTEGRATION, AND RESULTS: Sixteen randomized trials with a total of 28,138 women were considered. Data were available for 27,498 women. Oral misoprostol (600 microg) is less effective than injectable uterotonics in reducing blood loss at least 1000 mL (relative risk [RR] 1.36, 95% confidence interval [CI] 1.17, 1.58) and increases the use of additional uterotonics. Shivering and pyrexia (temperature greater than 38C) are the main side effects of misoprostol and are dose related. Compared with injectable uterotonics, the RR of "any shivering" with misoprostol (600 microg) is 3.27 (95% CI 3.01, 3.56) and pyrexia is 6.96 (95% CI 5.65, 8.57). The RR of blood loss of 500 mL or more is 1.11 (95% CI 0.87, 1.43) and the RR of use of additional uterotonics is 1.80 (1.13, 2.85) in the three trials (1441 women) comparing rectal misoprostol (400 microg) with injectable uterotonics. CONCLUSION: Injectable oxytocin or oxytocin-ergot preparations are more effective than misoprostol as part of the active management of the third stage of labor.

Administration, Oral↗
PubMed2001

WHO multicentre randomised trial of misoprostol in the management of the third stage of labour.

BACKGROUND: Postpartum haemorrhage is a leading cause of maternal morbidity and mortality. Active management of the third stage of labour, including use of a uterotonic agent, has been shown to reduce blood loss. Misoprostol (a prostaglandin E1 analogue) has been suggested for this purpose because it has strong uterotonic effects, can be given orally, is inexpensive, and does not need refrigeration for storage. We did a multicentre, double-blind, randomised controlled trial to determine whether oral misoprostol is as effective as oxytocin during the third stage of labour. METHODS: In hospitals in Argentina, China, Egypt, Ireland, Nigeria, South Africa, Switzerland, Thailand, and Vietnam, we randomly assigned women about to deliver vaginally to receive 600 microg misoprostol orally or 10 IU oxytocin intravenously or intramuscularly, according to routine practice, plus corresponding identical placebos. The medications were administered immediately after delivery as part of the active management of the third stage of labour. The primary outcomes were measured postpartum blood loss of 1000 mL or more, and the use of additional uterotonics without an unacceptable level of side-effects. We chose an upper limit of a 35% increase in the risk of blood loss of 1000 mL or more as the margin of clinical equivalence, which was assessed by the confidence interval of the relative risk. Analysis was by intention to treat. FINDINGS: 9264 women were assigned misoprostol and 9266 oxytocin. 37 women in the misoprostol group and 34 in the oxytocin group had emergency caesarean sections and were excluded. 366 (4%) of women on misoprostol had a measured blood loss of 1000 mL or more, compared with 263 (3%) of those on oxytocin (relative risk 1.39 [95% CI 1.19-1.63], p<0.0001). 1398 (15%) women in the misoprostol group and 1002 (11%) in the oxytocin group required additional uterotonics (1.40 [1.29-1.51], p<0.0001). Misoprostol use was also associated with a significantly higher incidence of shivering (3.48 [3.15-3.84]) and raised body temperature (7.17 [5.67-9.07]) in the first hour after delivery. INTERPRETATION: 10 IU oxytocin (intravenous or intramuscular) is preferable to 600 microg oral misoprostol in the active management of the third stage of labour in hospital settings where active management is the norm.

Adult↗
PubMed2001

Surgical procedures to evacuate incomplete abortion.

BACKGROUND: Incomplete abortion is a major problem that should be effectively managed with safe and appropriate procedures. Surgical evacuation of the uterus for management of incomplete abortion usually involves vacuum aspiration or sharp curettage. OBJECTIVES: To compare the safety and effectiveness of surgical uterine evacuation methods for management of incomplete abortion. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, Medline from 1966, Popline from 1970, and the Cochrane Controlled Trials Register. Trials were also identified from reference lists of reviews. Date of last search: October 2000. SELECTION CRITERIA: Randomized trials where different surgical methods were used to manage incomplete abortion were eligible for inclusion. DATA COLLECTION AND ANALYSIS: We extracted population characteristics, settings, and exclusion criteria, in addition to outcomes such as complications of the procedure, duration, need for re-evacuation, blood transfusion, and analgesia/anesthesia. MAIN RESULTS: Two trials were included. Vacuum aspiration was associated with statistically significantly decreased blood loss (-17 mls weighted mean difference, 95% confidence interval (CI) -24 to -10 mls), less pain (relative risk (RR): 0.74, 95% CI 0.61, 0.90), and shorter duration of procedure (-1.2 minutes weighted mean difference, 95% CI -1.5 to -0.87 minutes), than sharp curettage, in the single study that evaluated these outcomes. Serious complications such as uterine perforation and other morbidity were rare and the sample sizes of the trials were not large enough to evaluate small or moderate differences. REVIEWER'S CONCLUSIONS: Vacuum aspiration is safe, quick to perform, and less painful than sharp curettage, and should be recommended for use in the management of incomplete abortion. Analgesia and sedation should be provided as necessary for the procedure.

Abortion, Incomplete↗
PubMed2001

The gap between evidence and practice in maternal healthcare.

The expected improvement in maternal and perinatal health in developing countries has not yet materialized. In addition to the factors related to socioeconomic conditions, we have identified areas where large gaps between evidence and practice are apparent. These gaps are in clinical care, implementation of effective practices and in selecting research priorities. We present examples from our own research and the literature to illustrate these points.

Clinical Trials as Topic↗
PubMed2000

Anticonvulsants for women with pre-eclampsia.

BACKGROUND: Pre-eclampsia is a relatively common complication of pregnancy. Anticonvulsants are used in the belief they help prevent eclamptic fits and subsequent poor outcomes for mother and infant. OBJECTIVES: The objective of this review was to assess the effects of anticonvulsants for women with pre-eclampsia on the women and their children. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register, and the Cochrane Controlled Trials Register, 1999 Issue 3. SELECTION CRITERIA: Randomised trials comparing anticonvulsants with placebo or no anticonvulsants or comparisons of different anticonvulsants in women with pre-eclampsia. DATA COLLECTION AND ANALYSIS: Trial quality was assessed and data were extracted independently by two reviewers. MAIN RESULTS: Nine studies were included. Comparing magnesium sulphate with placebo/no anticonvulsant the relative risk (RR) of eclampsia was 0.33, 95% confidence interval (CI) 0.11 to 1.02. There was no significant difference detected in the risk of caesarean section (RR 1.04, 95% CI 0.92 to 1.17). Magnesium sulphate appeared to be better than phenytoin at reducing the risk of eclampsia (RR 0.05, 95% CI 0.00 to 0.84). However there was an increased risk of caesarean section with magnesium sulphate compared to phenytoin (RR 1.21, 95% CI 1.05 to 1. 41). No statistically significant differences were reported for any other clinically important outcomes. Studies comparing magnesium sulphate and diazepam were too small for any reliable conclusions. REVIEWER'S CONCLUSIONS: There is not enough evidence to establish the benefits and hazards of anticonvulsants for women with pre-eclampsia. If an anticonvulsant is used, magnesium sulphate appears to be the best choice.

Anticonvulsants↗
PubMed2000

Bed rest in hospital for suspected impaired fetal growth.

BACKGROUND: Bed rest in hospital or at home is widely advised for many complications of pregnancy. The increased clinical supervision needs to be balanced with the risk of thrombosis, the stress on the pregnant women, as well as the costs to families and health services. OBJECTIVES: The objective of this review was to assess the effects of bed rest in hospital for women with suspected impaired fetal growth. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of last search: December 1999. SELECTION CRITERIA: Randomised trials comparing a policy of bed rest in hospital with ambulatory management for women with suspected impaired fetal growth. DATA COLLECTION AND ANALYSIS: Trial quality was assessed. MAIN RESULTS: One study involving 107 women was included. Allocation of treatment was by odd or even birth date. There were differences in baseline fetal weights and birth weights, but these were not statistically significant (mean estimated fetal weight deviation at enrolment was -21.7% for the bed rest group and -20.7% for the ambulatory group; mean estimated birth weight was -19.7% for the bed rest group and -20.6% for the ambulatory group). No differences were detected between bed rest and ambulatory management for fetal growth parameters (relative risk 0.43, 95% confidence interval: 0.15 to 1. 27) and neonatal outcomes. REVIEWER'S CONCLUSIONS: There is not enough evidence to evaluate the use of a bed rest in hospital policy for women with suspected impaired fetal growth.

Bed Rest↗
PubMed2000

Betamimetics for suspected impaired fetal growth.

BACKGROUND: Betamimetic drugs may promote fetal growth by increasing the availability of nutrients and by decreasing vascular resistance. They may also induce adverse effects via their effects on carbohydrate metabolism. OBJECTIVES: The objective of this review was to assess the effects of betamimetic therapy for suspected impaired fetal growth on fetal growth and perinatal outcome. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register and the Cochrane Controlled Trials Register. Date of the latest search: December 1999. SELECTION CRITERIA: Randomised trials of betamimetic therapy compared with no betamimetic therapy or placebo in women with suspected impaired fetal growth. DATA COLLECTION AND ANALYSIS: Eligibility and trial quality was assessed. MAIN RESULTS: Two studies of 118 women were included. No differences were found between the betamimetic groups and the control groups for low birth weight (relative risk 1.17, 95% confidence interval 0.75 to 1.83), other anthropometric or neonatal morbidity and mortality measures. REVIEWER'S CONCLUSIONS: There is not enough evidence to evaluate the use of betamimetics in promoting fetal growth. Larger studies are needed to investigate possible adverse effects of long-term betamimetic administration.

Adrenergic beta-Agonists↗