Third Stage of Labor a Swedish Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Childbirth
• Interventions: Procedure: active management of the third stage of labor; Procedure: expectant management of the third stage of labor

• Registration Number: NCT01221051
• Lead Sponsor: Göteborg University

Brief 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

Detailed 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 Timeline

• Study Start: 2006-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1800

Inclusion Criteria

• healthy women with normal pregnancies
• gestational age of 34+0 - 43+0 weeks
• singleton, cephalic presentation
• expected vaginal birth

Exclusion Criteria

• non Swedish-speaking
• previous PPH >1000 mL
• elective Caesarean section
• pre-eclampsia
• grand multiparity (≥5)
• intrauterine fetal death

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	active management of the third stage of labor	early cord clamping, administration of oxytocin 10 IU i.v, controlled cord traction, uterine massage after placenta expulsion
saline solution	expectant management of the third stage of labor	early cord clamping, wait for signs of placenta detachment, encourage the woman to push out placenta by her own effort, uterine massage after placenta expulsion

Primary Outcome Measures

Name	Time	Method
blood loss	blood loss measured up to two hours post partum	All blood was collected and measured from delivery of the infant and two hours after.

Secondary Outcome Measures

Name	Time	Method
afterpains	at two hours postpartum and the day after delivery	Women assessed their afterpains at two hours and the day after delivery