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 MedDRA version: 21.1 Level: LLT Classification code 10036873 Term
Conditions
Interventions
Trade Name: Samarin
Product Name: Samarin
Pharmaceutical Form: Effervescent powder
INN or Proposed INN: SODIUM HYDROGEN CARBONATE
CAS Number: 144-55-8
Other descriptive name: SODIUM HYDROGEN CARBONATE
Sponsors
Hvidovre Hospital, Region Hovedstaden
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. ;Timepoint(s) of evaluation of this end point: The end points will be observed and evaluated immediately after the trial has ended. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no secondary end point(s) ;Timepoint(s) of evaluation of this end point: There are no secondary end point(s) | — |
Countries
Denmark
Contacts
Public ContactResearch student
Hvidovre Hospital, Region Hovedstaden
Outcome results
None listed