Third Stage of Labor a Swedish Randomized Controlled Trial

A Comparison of Active and Expectant Management of the Third Stage of Labor

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

Study Overview

• Status: Completed
• Conditions: Childbirth
• Intervention / Treatment: Procedure: active management of the third stage of labor; Procedure: expectant management of the third stage of labor

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 Type: Interventional
• Enrollment (Actual): 1800
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oxytocin; early cord clamping, administration of oxytocin 10 IU i.v, controlled cord traction, uterine massage after placenta expulsion	Procedure: active management of the third stage of labor; early cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion; Other Names: AMTSL
Placebo Comparator: saline solution; 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	Procedure: expectant management of the third stage of labor; early cord clamping, administer saline solution 2 mL i.v,wait for signs of placenta detachment, encourage the woman to push ot placenta by her own effort, uterine massage after placenta expulsion; Other Names: EMTSL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood loss	All blood was collected and measured from delivery of the infant and two hours after.	blood loss measured up to two hours post partum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
afterpains	Women assessed their afterpains at two hours and the day after delivery	at two hours postpartum and the day after delivery

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital
• Investigators: Principal Investigator: elisabeth jangsten, Sahlgrenska academy, University of Gothenburg

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: October 13, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimated): October 14, 2010

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: third stage of labor,oxytocics, postpartum hemorrhage,
• Other Study ID Numbers: VGFOUGSB-8290