E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A successful Labour is dependent on the ability of the uterus to produce co-ordinated contractions that are of both the right duration and intensity. A failure to produce these can result in an arrest or slow progress of Labour. In clinical terms an arrest or slow progress of Labour are the diagnostical criteria for Labour dystocia. Labour dystocia often leads to emergency cesarean section, instrumental deliveries and/or bleeding |
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E.1.1.1 | Medical condition in easily understood language |
Slow progress or arrest of labour |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036873 |
E.1.2 | Term | Prolonged labour, unspecified |
E.1.2 | System Organ Class | 100000004868 |
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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 |
The objectives of this study is to measure the effect of a repeated dose of bicarbonate on maternal blood-pH, blood-sugar and lactate in women during and after Labour. |
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E.2.2 | Secondary objectives of the trial |
This study will provide vital information for the preparation of a randomized controlled study of the effect of bicarbonate intake on prevention of Labour dystocia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible for inclusion in the study are all primiparous women above 18 without medical diseases with singleton pregnancy at or after 37+0 weeks of gestation, who are admitted in labour with contractions and dilation of orifcium between 4 and 8 cm. |
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E.4 | Principal exclusion criteria |
Women who do not fulfil the above-mentioned criteria. Women with chronical diseases such as diabetes along with women who are hypersensitive to any of the substances in Samarin®. Women with breech presentation. Women who deliver by caesarean section before the blood tests are performed. Women who are currently being treated with Tetracyclines, ketoconazol tablets or gabapentin tablets are excluded in accordance with the product summary for Samarin® |
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E.5 End points |
E.5.1 | Primary end point(s) |
To observe and maintain a stable pH between 7.35 and 7.45 in labouring women and to establish which interval the dose shall be given to maintain this level of pH during Labour.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The end points will be observed and evaluated immediately after the trial has ended. |
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E.5.2 | Secondary end point(s) |
There are no secondary end point(s)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
There are no secondary end point(s) |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |