Measurement of the bloods acidity and concentration of lactate acid in labouring women after they have been given bicarbonate.

Phase 1

• Conditions: 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: 21.1Level: LLTClassification code 10036873Term: Prolonged labour, unspecifiedSystem Organ Class: 100000004868; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2019-001216-38-DK
• Lead Sponsor: Hvidovre Hospital, Region Hovedstaden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-29
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 15

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

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®

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified