Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT01221051
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2010-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Third Stage of Labor a Swedish Randomized Controlled Trial
Sponsor:
Göteborg University
Organization:
Study Overview
Official Title:
A Comparison of Active and Expectant Management of the Third Stage of Labor
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: