When and How to Administer Oxytocin for Active Management of Third Stage of Labour

Not Applicable

Completed

• Conditions: Postpartum Bleeding
• Interventions: Procedure: after delivery of the fetus & when anterior shoulder seen; Drug: intravenous & intramuscular oxytocin

• Registration Number: NCT01954186
• Lead Sponsor: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Brief Summary

To compare the efficacy of the route and timing of oxytocin administration for Active management of third stage of labour (AMTSL).

Detailed Description

Our objective is to determine the most efficient route and timing of oxytocin administration by measuring the duration of third stage of labour, quantitative blood during the first hour after delivery and comparing haemoglobin and haematocrit changes and the need for additional interventions in patients who had either a spontaneous labour or received labour augmentation with oxytocin.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-10
• Study Completion: 2010-12
• Status Verified: 2013-09
• Study First Submitted: 2013-09-22
• Study First Submitted QC: 2013-09-26
• Last Update Submitted: 2013-09-26
• Study First Posted: 2013-10-01
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• having a singleton pregnancy above 37th gestational week
• normal live vaginal delivery with cephalic presentation
• being in active labor

Exclusion Criteria

• Fetal demise
• multiple pregnancy
• known coagulation disorder
• presentation anomalies
• placental pathology
• liver disease
• thrombocytopenia
• hypertension or being currently on anticoagulants
• having a cesarean section, operative delivery or deep vaginal tear
• chorioamnionitis
• developing HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count) or DIC (disseminated intravascular coagulation) before delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intravenous & intramuscular oxytocin	after delivery of the fetus & when anterior shoulder seen	intravenous or intramuscular 10 iu oxytocin
after delivery & when anterior shoulder seen	intravenous & intramuscular oxytocin	oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

Primary Outcome Measures

Name	Time	Method
postpartum bleeding in the third stage of labour	participants will be followed for the duration of hospital stay, an expected average of 48 hours

Trial Locations

Locations (1)

Etlik Zübeyde Hanım Women's Health Teaching and Research Hospital; 🇹🇷 Ankara, Turkey