None listed
Conditions
Brief summary
Pain is a predictable feature of the medical abortion process, and for some women pain may be intense. Although pain is the most common side-effect encountered with medical abortion, little is known about optimal pain management during this process. Currently, WHO recommends use of NSAIDs during medical abortion with mifepristone and misoprostol. Previous studies have shown that NSAIDs, particularly ibuprofen, reduce pain once uterine cramping has started and is superior to paracetamol; however, it does not appear to be effective at preventing or minimizing the moderate to severe pain of medical abortion when administered alone prior to pain onset. As pain is often cited as one of the worst features of medical abortion, and given that inadequate pain management may motivate some women to seek unnecessary clinical care, there is a clear need to identify the most effective methods of pain control in this setting. This study is a randomized, placebo-controlled trial of prophylactic analgesia for pain relief during early medical abortion with mifepristone and misoprostol. The primary objective of this study is to determine whether prophylactic administration of tramadol or ibuprofen plus metoclopramide is superior to analgesic administration after pain begins during the medical abortion process in terms of reducing maximal reported pain levels and subsequent use of pain medication (ibuprofen and oral narcotics).
Interventions
Group 1: Randomized to take tramadol 50 mg plus one placebo pill orally, immediately before taking the misoprostol dose (800 mcg vaginally or buccally), repeated once 4 hours later.
Group 2: Randomized to take ibuprofen 400 mg and metoclopramide 10 mg orally, immediately before taking the misoprostol dose (800 mcg vaginally or buccally), repeated once 4 hours later.
Group 3: Randomized to take two placebo pills orally, immediately before taking the misoprostol dose, repeated once 4 hou
Group 1: Randomized to take tramadol 50 mg plus one placebo pill orally, immediately before taking the misoprostol dose (800 mcg vaginally or buccally), repeated once 4 hours later. Group 2: Randomized to take ibuprofen 400 mg and metoclopramide 10 mg orally, immediately before taking the misoprostol dose (800 mcg vaginally or buccally), repeated once 4 hours later. Group 3: Randomized to take two placebo pills orally, immediately before taking the misoprostol dose, repeated once 4 hours later. All participants across treatment arms will also be given 4 tablets of ibuprofen 400 mg with instructions to take 1 tablet every 4 hours as needed, as well as 2 tablets of paracetamol with codeine with instructions to take 1 tablet every 4 hours as needed. Medications will be pre-packaged with accompanying VAS forms to facilitate accurate diary assessments.
Sponsors
World Health Organization
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria: Woman seeking medical abortion with mifepristone and misoprostol up to 63 days' gestation as determined by the site Age 18 or greater Willingness to participate in randomized study Ability to speak language(s) of site Sufficient reading and writing literacy in the language of the site to be able to read study instructions and complete home self-assessments Ability to give informed consent Ability and willingness to be contacted by telephone
Exclusion criteria
Exclusion criteria for the study are: Multiple gestation Suspicion of any pathology of pregnancy (e.g. molar, ectopic, non-viable pregnancy, threatened abortion) History of bleeding disorder or current anticoagulation therapy Ongoing use (> 4 weeks) of metoclopramide prior to study initiation Allergy to mifepristone or misoprostol Allergy to tramadol, ibuprofen, metoclopramide, paracetamol or codeine Gastritis or gastric ulcer or other contraindication to ibuprofen use A history or evidence of disorders that represent a contraindication to the use of mifepristone or misoprostol (chronic adrenal failure, severe asthma uncontrolled by corticosteroid therapy, inherited porphyries, glaucoma, mitral stenosis, hepatic or renal disease) A history or evidence of disorders that represent a contraindication to the use of metoclopramide (pheochromocytoma, epilepsy, concurrent use of medications known to induce extrapyramidal symptoms) A history or evidence of disorders that represent a contraindication to the use of tramadol (epilepsy, opioid dependency or alcohol abuse, concurrent use of medications known to result in CNS depression and/or lower seizure threshold) Presence of an intrauterine contraceptive device Severe anaemia (assessed clinically, or if measured, haemoglobin <9 mg/dl) Inability to return to site for follow-up visit AND not accessible by telephone No access to a time-keeping device
Outcome results
None listed