E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Miscarriage before 14 gestational weeks with a gestational sac in the uterus identified at ultrasound examiantion |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027650 |
E.1.2 | Term | Miscarriage of pregnancy |
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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 |
Main objective: to determine if there is a difference in the number of women with a complete miscarriage (contents in uterine cavity measuring < 16 mm in anterior-posterior diameter at transvaginal ultrasound examination and no or minimal bleeding) after 10 days between expectant management and treatment with 800 micrograms of misoprostol intravaginally in women with an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus |
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E.2.2 | Secondary objectives of the trial |
To determine if there is a difference between the two treatments in number of women with a complete miscarriage after 17, 24 and 31 days number and type of short time complications (infection, anemia) number of women who undergo surgical evacuation of the uterine cavity use of resources (medical consultations, telephone contacts, sick leave, hospitalisation) anxiety level, depression level and grief of the patients patient satisfaction number of women who are pregnant again within 14 months of their miscarriage being complete (calculated only for women with active desire of pregnancy)
To determine which factors can predict the success (complete miscarriage at 10 days) of the two treatments
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-at least 18 years of age -able to understand the information -incomplete miscarriage before 14 weeks, bleeding, closed cervix, gestational sac retained in the uterus (empty with size 16 mm or more or dead embryo 5 - 33 mm, or arrest in development of the pregnancy during at least 7 days of observation) -circulatory stable -Hemoglobin level at least 80g/L -no contraindications against use of misoprostol
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E.4 | Principal exclusion criteria |
(exclusion criteria = Not eligible) -Intrauterine pregnancy of uncertain viability -non-viable pregnancy WITHOUT bleeding -profuse bleeding requiring immediate surgical evacuation of the uterus -contraindications against misoprostol
Exclusions Lost to follow-up Severe hitherto unknown side effects of misoprostol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Complete miscarriage, defined as contents in uterine cavity measuring < 16 mm in anteroposterior diameter at transvaginal ultrasound examiantion and no or minimal bleeding, after 10 days |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
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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End of trial: 14 months after the patient who last was considered to have had a complete miscarraiage. Collection time 3 years + 14 months of follow up = 4.5 years
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |