High and low dose oxytocin for augmentation of labor

The effects of high versus low dose oxytocin on cesarean section rate, fetal and maternal outcomes for augmentation of labor in pregnant women gestational age > 37 weeks

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000900011

Enrollment

300

Registered

2010-10-25

Start date

2010-11-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Dystocia is the most common cause of cesarean section in primigravida, This would be improved by adequate augmentation of labor. The augmentation methods included amniotomy, prostaglandins or oxytocin adminiatration. Intravenous oxytocin infusion was a commonly method used for augmentation of labor, but standard regimen is still inconclusive. The prior study reported that high dose oxytocin was significantly decrease cesarean section rate without serious maternal and fetal complications when compared to low dose oxytocin. However, some studies showed that high dose was not superior to low dose in augmentation of labor but only shorten delivery time. After we intensively searched and reviewed the literature, we found that no prior study has been conducted in Thailand. We therefore would like to study the effectiveness and safety of high dose oxytocin in augmentation of labor when compared to low dose oxytocin. The primary endpoint is cesarean section rate and the secondary endpoints are duration of delivery and maternal and fetal complications.

Interventions

Arm 1: High dose oxytocin infusion (4 mU/minute and increase the rate by 4 mU/ml every 30 minutes with maximum dose not exceed 16 mU/ml (oxytocin 10 units in isotonic solution 1,000 ml) Arm 2: Low dose oxytocin infusion 2 mU/minute and increase the rate by 2 mU/ml every 30 minutes with maximum dose not exceed 16 mU/ml (oxytocin 10 units in isotonic solution 1,000 ml)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Yes

Inclusion criteria

Mother criteria 1. Singleton, gestational age 37 weeks or more 2. Vertex presentation 3. Bishop score = 9 or more 4. Inadequate uterine contraction Child criteria 1. Viable fetus 2. Singleton 3. Vertex presentation 4. well being fetus

Exclusion criteria

1. Contraindication for augmentation of labor e.g. malposition, placenta previa, prior uterine scar, overdistended uterus, grand multiparity 2. Cephalopelvic disproportion (CPD) 3. Dead fetus in utero (DFIU) 4. Contraindication in using oxytocin e.g. allergy to oxytocin, low blood pressure, fetal distress 5. Medical complications: hypertension, HIV infection, coagulopathy, diabetes mellitus, heart diseases

Outcome results