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Prolonged labour with increased risk of cesarean section and negative birth experience is common among first-time mothers. Treatment today is continuous infusion of synthetic oxytocin. Knowledge is lacking, however regarding the optimal dosage. In this study, healthy primiparous women with normal pregnancy, spontaneous start and prolonged progress will receive either high or low dose of oxytocin. Frequency of cesarean delivery, infant health and women's childbirth experience will be examened.

Phase 1
Conditions
abor dystocia (LD) also referred to as prolonged labour is a commonly identified problem in modern delivery care with three described possible causes: inefficient uterine action, occiputposterior position and cephalopelvic disproportion. Inefficient uterine action is the most frequent cause of LD and the most common complication of labour in primiparous women. LD is related to increased maternal morbidity and operative deliveries and is one of the main reasons for cesarean section.
MedDRA version: 14.1Level: LLTClassification code 10056139Term: Labour abnormalSystem Organ Class: 100000004868
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
Labor dystocia (LD) also referred to as prolonged labour is a commonly identified problem in modern delivery care with three described possible causes: inefficient uterine action, occiputposterior position and cephalopelvic disproportion. Inefficient uterine action is the most frequent cause of LD and the most common complication of labour in primiparous women. LD is related to increased maternal morbidity and operative deliveries and is one of the main reasons for cesarean section.
Registration Number
EUCTR2012-000356-33-SE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Inclusion criteria :
•healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
• confirmed delay in labour and with ruptured membranes

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 1376
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Inclusion criteria :
•healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
• confirmed delay in labour and with ruptured membranes

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 1376
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Inclusion criteria :
•healthy nulliparous women with a normal singleton pregnancy at term (37+0 – 41+6 weeks) gestation with fetus in vertex presentation and spontaneous onset of labour
• confirmed delay in labour and with ruptured membranes

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 1376
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy

;

Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy

;

Women under 18 years old,non-Swedish speaking women, women with previous uterine surgery, vaginal bleeding during labour of clinical significance, abnormal vertex presentation, fetal growth retardation > - 22 %, fetal heart rate abnormalities, heavy meconium staining, contra-indication to oxytocin therapy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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