First trimester threatened miscarriage treatment with human chorionic gonadotrophins: a randomised controlled trial.

OBJECTIVE: To determine whether administration of exogenous human chorionic gonadotrophin (hCG) treatment improve the pregnancy outcome in first trimester threatened miscarriages. DESIGN: A prospective, double blind, randomised, placebo-controlled trial. SETTING: The Early Pregnancy Assessment Unit, Royal Bolton Hospital, Bolton, United Kingdom. POPULATION: One hundred and eighty-three women with vaginal bleeding and a viable fetus seen on ultrasound scan (USS) in the first 12 weeks of pregnancy. METHODS: The patients were randomised to receive either hCG or placebo treatment until 14 weeks of gestation. MAIN OUTCOME MEASURES: The primary objective of the trial was to determine the miscarriage rate in the hCG arm compared from the placebo arm. RESULTS: Of the 183 cases, 87 were randomised to treatment with hCG while 96 were randomised to receive a placebo. Forty-seven (25%) did not comply with the study protocol. The mean [SD] gestational age at presentation was 7 [1.33] weeks. The mean [SD] age of women in study was 27 [5] years in the placebo and 28 [5] in the hCG group. The mean body mass index (kg/m(2)) was 25 [5] in the study. The number of patients actively bleeding per vaginum at presentation was 85 (93%) in placebo group and 79 (96%) in the hCG group. The median number of hCG or placebo injections for both groups was 7. Ten women (11%) in the placebo group proceeded to have a complete miscarriage, as did 10 women (12%) in the hCG group, relative risk (RR) [95% confidence interval (CI)] of 1.1 (0.63-1.6). CONCLUSION: Our study showed no evidence of a difference in the outcome of threatened miscarriages when treated with hCG in the first trimester, this may be because our study sample size was small and follow up was suboptimal. A large, randomised, multicentre trial is still needed to establish the usefulness of hCG treatment in cases of threatened miscarriage.

Medical termination of missed abortion.

Missed abortions are a common occurrence and represent a heavy gynaecological emergency workload to both medical and nursing staff. The conventional method using vacuum aspiration of uterus is associated with morbidity and mortality. Medical termination of pregnancy is accepted as a safe and effective alternative method. However, medical evacuation of uterus in missed abortions had not been fully investigated. In this study we hope to examine the efficacy of medical methods for terminating missed abortions. Mifepristone and misoprostol prescribed to 100 women with an ultrasonically confirmed missed abortion was compared with 100 women who had surgical evacuation under general anaesthesia for their missed abortion. The disparity in complications between medical and surgical groups was not significantly different (Student's t-test, P=0.5). This study showed medical evacuation of missed abortion to be an effective, safe and cost-effective, alternative to surgical evacuation of the uterus and is particularly suited to women not wanting hospital admission or a surgical procedure under general anaesthesia. It represents an option of management that can be less intrusive and gives the woman some control but is both safe and effective.

Uterine exteriorisation at caesarean section: influence on maternal morbidity.

OBJECTIVE: To compare the influence on caesarean section morbidity of uterine exteriorisation or in situ repair. DESIGN: Randomised controlled trial. SETTING: Princess Anne Maternity Unit of the Royal Bolton Hospital, UK. POPULATION: One hundred and ninety-four women undergoing delivery by caesarean section. METHODS: Two intra-operative readings of arterial pulse rate, mean arterial blood pressure, and arterial haemoglobin oxygen saturation were obtained. Pre-operative and day-3 haemoglobin concentrations were determined. Intra- and post-operative complications, puerperal pain scores, and febrile and infectious morbidity were assessed. A postal questionnaire was used to assess morbidity six weeks after delivery. MAIN OUTCOME MEASURES: Intra-operative changes in pulse rate, mean arterial blood pressure and oxygen saturation; peri-operative changes in haemoglobin concentration; incidence of intraoperative vomiting, pain, intra- and post-operative complications, and febrile and infectious morbidity; immediate and late puerperal pain scores; satisfaction with the operation. RESULTS: No clinically significant differences between uterine exteriorisation and in situ repair were found in pulse rate, mean arterial pressure, oxygen saturation and haemoglobin changes. Likewise, the incidence of vomiting and pain was similar. Vomiting occurred in 10% of all the women, and 57% of all pain complaints occurred at the initial skin incision. There was a trend towards higher immediate and late pain scores in the exteriorisation group, reaching statistical significance on day 3. Overall, pain scores averaged 6/10 on day 1 despite patient-controlled analgesia, and three-quarters of all women reported persisting pain on day 42. Intra- and post-operative complications, febrile and infectious morbidity, and duration of hospital stay were similar in both groups. CONCLUSIONS: We have demonstrated that uterine exteriorisation and in situ repair have similar effects on peri-operative caesarean section morbidity. Intra-operative pain reflected adequacy of anaesthesia, while vomiting reflected adequacy of pre-operative preparation of patients. Exteriorising the uterus at caesarean section is a valid option.