Third Stage of Labor a Swedish Randomized Controlled Trial

Childbirth Clinical Trial

Official title: A Comparison of Active and Expectant Management of the Third Stage of Labor

Status Completed

Clinical Trial Summary

The purpose with this study was to compare blood loss and women's experience of afterpains during the third stage when handled with active or expectant management of the third stage of labour.

Hypothesis 1. To detect a 5% difference (15% vs 10%) in blood loss >1000 mL between the two groups with 80% power (α=0.05), at least 726 subjects were required in each group.

Hypothesis 2. Afterpains are more pronounced in active compared to expectant management during the third stage of labour

Clinical Trial Description

Management of the third stage of labour has been focus for investigation during decades and active management of the third stage of labour (AMTSL)has been recommended in all women giving birth vaginally at hospitals. In Sweden the recommendation has been to give an injection of oxytocin immediately after birth of the neonate but not the entire AMTSL procedure.

Women in labour were asked to participate voluntarily when entering the hospital and after acceptance they were randomised to either active or expectant management of the third stage of labour(EMTSL).

AMTSL included:

• Early cord clamping

• 10 UI oxytocin i.v

• controlled cord traction

• uterine massage after placenta expulsion

EMTSL included:

• early cord clamping

• 2 mL saline solution i.v

• wait for signs of placenta detachment

• encourage the women to push out placenta by her own effort

• uterine massage after placenta expulsion

All blood was measured by weighing bed pads and sanitary towels up to two hours postpartum Assessment of afterpains was performed by a Visual Analogue Scale (VAS) and the Pain-o-meter (POM-WDS) two hours after the delivery of placenta, and the day after childbirth. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childbirth

• NCT number: NCT01221051
• Study type: Interventional
• Source: Göteborg University
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Completion date: April 2008