Third Stage of Labor a Swedish Randomized Controlled Trial

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Childbirth

Intervention / Treatment
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* Procedure: active management of the third stage of labor
* Procedure: expectant management of the third stage of labor


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxytocin<br>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<br>* early cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion<br>* Other names: AMTSL;|
| Placebo Comparator: saline solution<br>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<br>* 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<br>* Other names: EMTSL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| afterpains | Women assessed their afterpains at two hours and the day after delivery | at two hours postpartum and the day after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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third stage of labor,oxytocics, postpartum hemorrhage,