Third Stage of Labor a Swedish Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT01221051
First received: October 13, 2010
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention
Childbirth
Procedure: active management of the third stage of labor
Procedure: expectant management of the third stage of labor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Comparison of Active and Expectant Management of the Third Stage of Labor

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • blood loss [ Time Frame: blood loss measured up to two hours post partum ] [ Designated as safety issue: Yes ]
    All blood was collected and measured from delivery of the infant and two hours after.


Secondary Outcome Measures:
  • afterpains [ Time Frame: at two hours postpartum and the day after delivery ] [ Designated as safety issue: No ]
    Women assessed their afterpains at two hours and the day after delivery


Enrollment: 1800
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: EMTSL

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221051

Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
Principal Investigator: elisabeth jangsten Sahlgrenska academy, University of Gothenburg
  More Information

No publications provided

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01221051     History of Changes
Other Study ID Numbers: VGFOUGSB-8290
Study First Received: October 13, 2010
Last Updated: March 30, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
third stage of labor,oxytocics, postpartum hemorrhage,

ClinicalTrials.gov processed this record on September 18, 2014