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

Postpartum Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954186
• Other study ID #: EtlikWHTH
• Status: Completed
• Phase: N/A
• First received: September 22, 2013
• Last updated: September 26, 2013
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2013
• Source: Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Postpartum Bleeding
• Postpartum Hemorrhage

Intervention

Drug:
• intravenous & intramuscular oxytocin
intravenous or intramuscular 10 iu oxytocin

Procedure:
• after delivery of the fetus & when anterior shoulder seen
oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered

Locations

Country	Name	City	State
Turkey	Etlik Zübeyde Hanim Women's Health Teaching and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum bleeding in the third stage of labour		participants will be followed for the duration of hospital stay, an expected average of 48 hours	Yes