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NCT Number: NCT01221051

Third Stage of Labor a Swedish Randomized Controlled Trial

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

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Key information

Conditions

Childbirth Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active management of the third stage of labor

Procedure

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

Other names: AMTSL

expectant management of the third stage of labor

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

Other names: EMTSL

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Oct 14, 2010
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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