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1.
Obstet Gynecol ; 137(5): 801-809, 2021 05 01.
Article in English | MEDLINE | ID: mdl-33831935

ABSTRACT

OBJECTIVE: To assess the efficacy of pretreatment with mifepristone before misoprostol, compared with misoprostol alone, for termination of pregnancy after a fetal death in the second trimester. METHODS: This prospective, double blind, placebo-controlled trial randomized women requiring a termination of pregnancy after fetal death between 14 and 28 weeks of gestation to placebo or 200 mg mifepristone orally 24-48 hours before the termination of pregnancy with misoprostol (400 micrograms every 6 hours vaginally for women at 24 weeks of gestation or less, and 200 micrograms every 4 hours vaginally for women at 24 weeks of gestation or more). Based on a median labor with misoprostol alone in the second trimester of 13 hours, a sample size of 116 women per group was planned to compare the primary outcome of time from administration of misoprostol to delivery. The trial was ceased after 66 women were enrolled secondary to prolonged time to achieve recruitment. RESULTS: From April 2013 to November 2016, 66 women were randomized (34 to placebo and 32 to mifepristone). There were no differences in the characteristics between the two groups. The median time for the primary outcome of administration of misoprostol to delivery in the placebo group was 10.5 hours, compared with 6.8 hours in the treatment group (hazard ratio 2.41 95% CI 1.39-4.17, P=.002). Women in the placebo group required more doses of misoprostol (3.4 vs 2.1, P=.002) and more misoprostol overall (1,181.8 micrograms, vs 767.7 micrograms, P=.003). There was no difference in maternal complications between the two groups. Women in the mifepristone group reported improved perception of the procedure. CONCLUSION: The sequential use of mifepristone and misoprostol for the termination of pregnancy after fetal deaths between 14 and 28 weeks of gestation reduces the time to delivery, compared with the use of misoprostol alone, with no worsening of maternal complications. CLINICAL TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12612000884808.


Subject(s)
Abortifacient Agents , Abortion, Induced , Mifepristone , Misoprostol , Adult , Double-Blind Method , Female , Fetal Death , Humans , Pregnancy , Pregnancy Trimester, Second , Prospective Studies , Treatment Outcome , Young Adult
2.
Int J Clin Pharm ; 39(1): 133-138, 2017 Feb.
Article in English | MEDLINE | ID: mdl-27933489

ABSTRACT

Background Postnatal pain is one of the limiting factors in the recovery of women from child birth. Despite the routine prescribing of analgesics for postnatal pain, limited research is available on the use of analgesics by the women in postnatal period. Objective To measure the utilisation and effectiveness of prescribed oral analgesics, the incidence and severity of pain, and factors associated with poor pain control on the fifth-day post-hospital discharge in postnatal women. Setting A tertiary referral women's hospital of Western Australia. Method Prospective cohort follow-up study of 400 postnatal women at a tertiary referral women's hospital during May and July 2014. All eligible subjects were contacted for a telephone survey 5 days after their discharge from the hospital. Additional clinical data was collected from the hospital medical records. Main outcome measure Pain at discharge, analgesics prescribed on discharge, patient understanding and adherence, and postnatal pain management. Results 197 of 400 recruited women completed the telephone survey yielding a response rate of around 50%. 131 Women (66%) reported to be in pain at the fifth-day post-hospital discharge. Older women (p = 0.003) and women who reported to be in pain at hospital discharge were more likely to experience pain at home (p = 0.001). Women were more likely to seek consultation from a healthcare professional (p = 0.001) prior to their scheduled follow up visit, purchase over the counter analgesics from pharmacy (p = 0.012) and seek non-drug alternative (p = 0.019) if they experienced pain at home. Conclusion Pain at hospital discharge was found to be a strong predictor of pain at home among the postnatal women in this study. We propose pain at the time of hospital discharge as a useful clinical indicator to identify postnatal women who need additional support to manage their pain at home thus minimising potential harm related to inappropriate use of medications.


Subject(s)
Analgesia/trends , Pain Measurement/trends , Pain/drug therapy , Patient Discharge/trends , Patient Participation/trends , Postnatal Care/trends , Adult , Analgesia/methods , Analgesics/therapeutic use , Comprehension , Female , Follow-Up Studies , Humans , Pain/diagnosis , Pain Measurement/methods , Patient Participation/methods , Postnatal Care/methods , Pregnancy , Prospective Studies , Surveys and Questionnaires
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