Not Yet RecruitingPhase 2ACTRN12610000900011

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


Sponsor

Suppasiri Hayakungchat

Enrollment

300 participants

Start Date

Nov 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Females

Inclusion Criteria10

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

Exclusion Criteria5

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

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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 d

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)


Locations(1)

Khon Kaen, Thailand

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