Third Stage of Labor a Swedish Randomized Controlled Trial

NCT ID: NCT01221051

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-04-30

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.

Conditions

Childbirth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

oxytocin

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

Group Type: ACTIVE_COMPARATOR

active management of the third stage of labor

Intervention Type: PROCEDURE

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

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

Group Type: PLACEBO_COMPARATOR

expectant management of the third stage of labor

Intervention Type: 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

Interventions

active management of the third stage of labor

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

AMTSL; EMTSL

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: collaborator

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

elisabeth jangsten

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska academy, University of Gothenburg

Other Identifiers

VGFOUGSB-8290

Identifier Type: -

Identifier Source: org_study_id