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Third Stage of Labor a Swedish Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT01221051
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : April 2, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment
Childbirth Procedure: active management of the third stage of labor Procedure: expectant management of the third stage of labor

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Comparison of Active and Expectant Management of the Third Stage of Labor
Study Start Date : November 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Secondary Outcome Measures :
  1. afterpains [ Time Frame: at two hours postpartum and the day after delivery ]
    Women assessed their afterpains at two hours and the day after delivery


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01221051


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

Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01221051     History of Changes
Other Study ID Numbers: VGFOUGSB-8290
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs