Implementation of measurement of lactate in amniotic fluid for treatment of dystocia

Implementation project of AFL in clinical practice

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003712-12-SE

Enrollment

Unknown

Registered

2016-10-28

Start date

2016-12-20

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with arrested labour

Interventions

Trade Name: Oxytocin Pilum Pharmaceutical Form: Infusion Trade Name: Ringer-acetat Fresenius Kabi infusionsvätska, lösning Pharmaceutical Form: Infusion Trade Name: Samarin Pharmaceutical Form: Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women with arrested labour, who are to be infused with Oxycontin and have a level of lactate in amniotic fluid of equal to or above 12,0 mmol/l 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 5000 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Delivering women who are not to be treated with Oxytocin Infusion or have a level of laktate in amniotic FLuid that is less than 12,0 mmol/l

Design outcomes

Primary

Measure	Time frame
Main Objective: To study best treatment method of women with an arrested labour and high values of lactate in amniotic fluid (>12mmol/l);Secondary Objective: Not applicable;Primary end point(s): The frequency of partus normalis in the different treatment groups;Timepoint(s) of evaluation of this end point: The end point will be evaluated three times during the project: 1. When 1/3 of the patients have been included. 2. When 2/3 of the patients have been included. 3. When last patient have been included	—

Measure

Time frame

Main Objective: To study best treatment method of women with an arrested labour and high values of lactate in amniotic fluid (>12mmol/l);Secondary Objective: Not applicable;Primary end point(s): The frequency of partus normalis in the different treatment groups;Timepoint(s) of evaluation of this end point: The end point will be evaluated three times during the project: 1. When 1/3 of the patients have been included. 2. When 2/3 of the patients have been included. 3. When last patient have been included

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Sweden

Contacts

Public ContactKvinnokliniken

Södersjukhuset AB

eva@itzel.eu

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026