多巴胺激动剂预防特发性高催乳素血症和复发性流产史女性的未来流产
References
References to studies included in this review
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Characteristics of studies
Characteristics of included studies [ordered by study ID]
| Methods | Random allocation to 2 groups using a computer‐generated random number table. | |
| Participants | Inclusion criteria: women diagnosed with idiopathic hyperprolactinemia; had a history of 2 or more consecutive miscarriages without other etiologic factors; of normal weight (body mass index, 19 kg to 24 kg/m2). Exclusion criteria: women with prolactin disorders, endocrinologic abnormalities (e.g. luteal phase dysfunction, polycystic ovaries, LH hypersecretion, and thyroid hormone disorders or any other etiologic factors for recurrent spontaneous abortion). Hyperprolactinemic women who were taking medications that would affect serum prolactin levels were also excluded. Enrollment: 48 women were allocated (24 intervention, 24 control) before conception. After enrollment, 2 women in control group dropped out of the study. The reason for dropout was not given. | |
| Interventions | Intervention group (n = 24): before conception, bromocriptine (2.5 to 5.0 mg/day) was given to women in this group until the end of the 9th week of gestation in whom the serum prolactin levels and the responses to TRH were normalized. Control group (n = 22): no treatment was given. 46 women in total (42 pregnancies ‐ 4/46 women did not conceive during the study period ‐ 21/24 in the bromocriptine group and 21/22 in the no‐treatment control. | |
| Outcomes | Rates of live birth. Rates of miscarriage. Rates of conception. Prolactin levels. | |
| Notes | Setting: the study took place in Yokohama City University Hospital, Japan. Date of study: not stated. Follow‐up: women were followed during the treatment and observation for 1 year. Prolactin levels were collected weekly between 4th and 12th gestational weeks during early pregnancy. Source of funding: supported in part by the National Cooperative Prevention Program for Mental and Physical Disorders, Ministry of Health and Welfare of Japan. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random schedules generated by computer. |
| Allocation concealment (selection bias) | Unclear risk | Not stated. |
| Blinding of participants and personnel (performance bias) | High risk | Blinding not reported. There was no placebo control (control was no treatment). |
| Blinding of outcome assessment (detection bias) | Unclear risk | Not stated. |
| Incomplete outcome data (attrition bias) | Low risk | 2 women in control group dropped out of the study after enrollment. The reasons for dropouts were not explained. The rate of missing data was 4.2%. |
| Selective reporting (reporting bias) | Unclear risk | The trial protocol was not available. Each outcome discussed in the methods sections was reported up except that serum prolactin levels were only reported in those pregnant women. The trial report does not mention specific adverse events as |
| Other bias | Low risk | None apparent. |
LH: luteinizing hormone
TRH: thyrotropin‐releasing hormone
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Miscarriages Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.28 [0.09, 0.87] |
| Analysis 1.1  Comparison 1 Dopamine agonists alone versus no treatment, Outcome 1 Miscarriages. | ||||
| 2 Live births Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.5 [0.93, 2.42] |
| Analysis 1.2  Comparison 1 Dopamine agonists alone versus no treatment, Outcome 2 Live births. | ||||
| 3 Conception Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.92 [0.77, 1.09] |
| Analysis 1.3  Comparison 1 Dopamine agonists alone versus no treatment, Outcome 3 Conception. | ||||
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Comparison 1 Dopamine agonists alone versus no treatment, Outcome 1 Miscarriages.
Comparison 1 Dopamine agonists alone versus no treatment, Outcome 2 Live births.
Comparison 1 Dopamine agonists alone versus no treatment, Outcome 3 Conception.
| Bromocriptine treatment versus no treatment for preventing future miscarriage in women with idiopathic hyperprolactinemia and recurrent miscarriage history | ||||||
| Patient or population: women with idiopathic hyperprolactinemia and recurrent miscarriage history Comparison: no treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | No of participants | Quality of the evidence | Comments | |
| Risk with placebo/no treatment | Risk with Dopamine agonists alone | |||||
| Miscarriages | Study population | RR 0.28 | 46 | ⊕⊕⊝⊝ | ||
| 455 per 1000 | 127 per 1000 | |||||
| Moderate | ||||||
| 455 per 1000 | 127 per 1000 | |||||
| Live births | Study population | RR 1.50 | 46 | ⊕⊝⊝⊝ | ||
| 500 per 1000 | 750 per 1000 | |||||
| Moderate | ||||||
| 500 per 1000 | 750 per 1000 | |||||
| Conception | Study population | RR 0.92 | 46 | ⊕⊝⊝⊝ | ||
| 955 per 1000 | 878 per 1000 | |||||
| Moderate | ||||||
| 955 per 1000 | 878 per 1000 | |||||
| Proportion reduction in serum prolactin levels | Study population | Not estimable | 0 | See comment | No data in included study | |
| See comment | See comment | |||||
| Moderate | ||||||
| Serum prolactin normalization | Study population | Not estimable | 0 | See comment | No data in included study | |
| See comment | See comment | |||||
| Moderate | ||||||
| Adverse maternal effects | Study population | Not estimable | 0 | See comment | No data in included study | |
| See comment | See comment | |||||
| Moderate | ||||||
| Adverse fetal outcomes | Study population | Not estimable | 0 | See comment | No data in included study | |
| See comment | See comment | |||||
| Moderate | ||||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
| 1 One trial with design limitations, including no description of allocation concealment, lack of blinding and possible outcome reporting bias (‐1). | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Miscarriages Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.28 [0.09, 0.87] |
| 2 Live births Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.5 [0.93, 2.42] |
| 3 Conception Show forest plot | 1 | 46 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.92 [0.77, 1.09] |
