E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain during Medical termination of pregnancy |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Adequate analgesia is crucial in patients undergoing medical abortion.
Our trial is prospective study in which we compare pain experience and sufficiency on pain medication in in teen-aged and adult women undergoing medical abortion in early pregnancy (gestational age <9+0). Patients get the pain medication according our hospital's present recommendation. Our main target is to evaluate adequacy of our present analgesics and to optimize pain medication in the future among women undergoing medical abortion.
We hope to create a guideline based on research data so that all patients receive adequate analgesia in the future. |
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E.2.2 | Secondary objectives of the trial |
We hope to be better able to recognize patients experiencing severe pain during medical abortion.
Experience of painful and traumatic abortion may affect patients' future plans for pregnancies and childbirth. In addition this may lead patient to choose surgical abortion in case of reapportion, which exposes patient to operative risks. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Our study is two-parted. Second part is intervention study. We compare in controlled prospective randomized study the PCA to our standard pain management in patients in medical termination of pregnancy with gestational age over 9 weeks. Patients are divided on two groups according to gestational age: H9+0-11+6 and H12+0-19+6. In addition we compare teen-aged and adult women together in both groups. This part has its own application on EudraCT done. |
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E.3 | Principal inclusion criteria |
Patients choosing medical abortion, are first time pregnant ag are aged between 15 to 19years and 25 to 35 years. Attending the study is voluntary |
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E.4 | Principal exclusion criteria |
-Abortion is done based on foetal abnormality or threat of patient's own health - More than one fetus -Patient's serious illness (ASA 3 or more) -Known allergy to one of the trial drugs -Problems of understanding
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain management with ibuprofen and paracetamol is adequate in most cases and at principal patients do not need to have stronger analgesics. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Collecting data takes about 1-2 years and is done by the end of the year 2017. |
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E.5.2 | Secondary end point(s) |
Predicting factors of pain are patient's young age, history of dysmenorrhea, anxiety. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Data is collected and ready to be evaluated in the end of the year 2017. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.1.7.1 | Other trial design description |
Etenevä otantatutkimus, kyselytutkimus |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Recruiting patients starts in the beginning of the year 2016 and lasts 1-2 years. Patients come to policlinics due to wish to have an abortion, Medical abortion is done at patients' home (excluding underaged women who come to hospital ward) and at last to follow-up visit 2-4 weeks after the abortion. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |