Wilton L V, Pearce G L, Martin R M, Mackay F J, Mann R D
Br J Obstet Gynaecol. 1998 Aug;105(8):882-9. doi: 10.1111/j.1471-0528.1998.tb10234.x.
To determine the proportion and nature of congenital anomalies in babies born to women exposed to newly marketed drugs during the first trimester.
Non-interventional observational cohort studies.
The women were identified in confidence by the Prescription Pricing Authority. The doctor was sent a questionnaire to determine clinical events, including pregnancy, occurring after the drug was dispensed. A supplementary questionnaire determined the outcome of each reported pregnancy.
General medical practice in England.
Women exposed to newly marketed drugs in whom pregnancy was recorded.
Outcomes of pregnancies, the proportion and nature of congenital anomalies in the babies born.
2511 pregnancies were reported. In 831 of these pregnancies a newly marketed drug had been taken during the first trimester and in 74 during the second/third trimester. The outcome was ascertained for 780 (94%) of these 831 pregnancies: 547 (66%) births; 10 (1%) ectopic pregnancies; 94 (11%) spontaneous miscarriages; 5 (< 1%) missed abortions; 120 (14%) legal abortions; and 4 (< 1%) intrauterine deaths. 557 infants were born, of whom 14 (2.5%) had congenital anomalies.
The proportion of live infants with a congenital abnormality born to mothers exposed to newly marketed drugs in the first trimester was similar to the percentage of congenital anomalies estimated by the Office for National Statistics. These data add valuable information to the safety database of these drugs.
确定在孕早期接触新上市药物的女性所生婴儿中先天性异常的比例和性质。
非干预性观察队列研究。
由处方定价管理局保密识别这些女性。向医生发送问卷以确定在配药后发生的临床事件，包括妊娠情况。一份补充问卷确定每次报告妊娠的结局。
英国的全科医疗。
记录有妊娠情况且接触新上市药物的女性。
妊娠结局，所生婴儿中先天性异常的比例和性质。
共报告了2511例妊娠。其中831例妊娠在孕早期服用了新上市药物，74例在孕中期/孕晚期服用。这831例妊娠中有780例（94%）的结局得以确定：547例（66%）为活产；10例（1%）为异位妊娠；94例（11%）为自然流产；5例（<1%）为稽留流产；120例（14%）为人工流产；4例（<1%）为宫内死亡。共出生557名婴儿，其中14例（2.5%）有先天性异常。
孕早期接触新上市药物的母亲所生的有先天性异常的活产婴儿比例与国家统计局估计的先天性异常百分比相似。这些数据为这些药物的安全数据库增添了有价值的信息。
