Third Stage of Labor a Swedish Randomized Controlled Trial

Göteborg University

Status: Completed

Conditions: Childbirth

Treatments: Procedure: expectant management of the third stage of labor; Procedure: active management of the third stage of labor

Study type: Interventional

Funder types: Other

Identifiers

NCT01221051

VGFOUGSB-8290

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,800 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups, including a placebo group

oxytocin

Active Comparator group

Description:

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

Treatment:

Procedure: active management of the third stage of labor

saline solution

Placebo Comparator group

Description:

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

Treatment:

Procedure: expectant management of the third stage of labor