Third Stage of Labor a Swedish Randomized Controlled Trial

Childbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01221051
• Other study ID #: VGFOUGSB-8290
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: March 30, 2012
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2012
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childbirth

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	afterpains	Women assessed their afterpains at two hours and the day after delivery	at two hours postpartum and the day after delivery	No