Third Stage of Labor a Swedish Randomized Controlled Trial

NCT01221051 | Completed

• 1 other identifier: VGFOUGSB-8290
• Study Type: interventional
• Target: 1,800
• Locations: 0 countries
• Sites: N/A

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

Conditions

Childbirth

Keywords

third stage of labor,oxytocics, postpartum hemorrhage,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• afterpains

  at two hours postpartum and the day after delivery

Study Arms (2)

oxytocin

ACTIVE COMPARATOR

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

saline solution

PLACEBO COMPARATOR

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

Interventions

active management of the third stage of labor PROCEDURE

early cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion

Also known as: AMTSL

oxytocin

expectant management of the third stage of labor PROCEDURE

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

Also known as: EMTSL

saline solution

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• elisabeth jangsten

  Sahlgrenska academy, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: October 14, 2010
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 1, 2025

Record last verified: 2025-03