Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days’ gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trialReportar como inadecuado




Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days’ gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Reproductive Health

, 13:132

First Online: 12 October 2016Received: 18 September 2016Accepted: 03 October 2016DOI: 10.1186-s12978-016-0246-5

Cite this article as: Dragoman, M.V., Grossman, D., Kapp, N. et al. Reprod Health 2016 13: 132. doi:10.1186-s12978-016-0246-5

Abstract

BackgroundPain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting.

Methods-DesignWe propose a randomized, placebo-controlled trial. 576 participants 288 nulliparous; 288 parous from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: 1 ibuprofen 400 mg PO and metoclopramide 10 mg PO; 2 tramadol 50 mg PO and a placebo; or 3 two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days’ gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women’s physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion.

DiscussionAlthough pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed.

Trial registrationACTRN12613000017729 Prospectively registered 8-1-2013.

KeywordsMedical abortion Mifepristone Misoprostol Pain management AbbreviationsANOVAAnalysis of variance

CONSORTConsolidated standards of reporting trials

DSMBData safety monitoring board

EMAEarly medical abortion

ITTIntention-to-treat

IV PCAIntravenous patient-controlled analgesia

NSAIDNonsteroidal anti-inflammatory drug

OCOpenClinica

RCTRandomized, controlled trial

VASVisual analog scale

WHOWorld health organization

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Autor: Monica V. Dragoman - Daniel Grossman - Nathalie Kapp - Nguyen My Huong - Ndema Habib - Duong Lan Dung - Anand Tamang

Fuente: https://link.springer.com/







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