ChildbirthNCT01221051
Third Stage of Labor a Swedish Randomized Controlled Trial
A study testing active management of the third stage of labor and expectant management of the third stage of labor in people with Childbirth, run by Göteborg University.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth
- What is being tested?
- active management of the third stage of labor and expectant management of the third stage of labor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,800 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy women with normal pregnancies
- gestational age of 34+0 - 43+0 weeks
- singleton, cephalic presentation
- expected vaginal birth
Who cannot join
- non Swedish-speaking
- previous PPH >1000 mL
- elective Caesarean section
- pre-eclampsia
- grand multiparity (≥5)
- intrauterine fetal death
About this study
Official title: A Comparison of Active and Expectant Management of the Third Stage of Labor
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
Read the 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.
- Conditions
- Childbirth
- Being tested
- active management of the third stage of labor, expectant management of the third stage of labor
- Keywords
- third stage of labor,oxytocics, postpartum hemorrhage,
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active management of the third stage of laborProcedure or surgery
Also called AMTSL
early cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion
expectant management of the third stage of laborProcedure or surgery
Also called EMTSL
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
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Active comparator | early cord clamping, administration of oxytocin 10 IU i.v, controlled cord traction, uterine massage after placenta expulsion Receives: Procedure: active management of the third stage of labor |
| saline solution | Placebo comparator | 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 Receives: Procedure: expectant management of the third stage of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
All blood was collected and measured from delivery of the infant and two hours after.
Measured: blood loss measured up to two hours post partum
Secondary outcomes (1)
afterpains
Women assessed their afterpains at two hours and the day after delivery
Measured: at two hours postpartum and the day after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startNov 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildbirthStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- elisabeth jangsten, Principal investigator, Sahlgrenska academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221051
- Sponsor's protocol ID
- VGFOUGSB-8290
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2010
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Active and Expectant Management of the Third Stage of Labor
- ClinicalTrials.gov ID
- NCT01221051
- Acronym / sponsor ID
- VGFOUGSB-8290
- Conditions
- Childbirth
- Keywords
- third stage of labor,oxytocics, postpartum hemorrhage,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Active comparator | Procedure: active management of the third stage of laborearly cord clamping, administration of oxytocin 10 IU i.v, controlled cord traction, uterine massage after placenta expulsion |
| saline solution | Placebo comparator | Procedure: expectant management of the third stage of laborearly cord clamping, wait for signs of placenta detachment, encourage the woman to push out placenta by her own effort, uterine massage after placenta expulsion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- healthy women with normal pregnancies
- gestational age of 34+0 - 43+0 weeks
- singleton, cephalic presentation
- expected vaginal birth
Key exclusion criteria (6 listed)
- non Swedish-speaking
- previous PPH >1000 mL
- elective Caesarean section
- pre-eclampsia
- grand multiparity (≥5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active management of the third stage of laborAlso: AMTSLearly cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion | Procedure or surgery | oxytocin |
| expectant management of the third stage of laborAlso: EMTSLearly 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 | Procedure or surgery | saline solution |
Primary outcome
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.
1 secondary outcome
afterpains
Time frame: at two hours postpartum and the day after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
elisabeth jangsten principal investigator
Sahlgrenska academy, University of Gothenburg
Questions about this trial
What is this clinical trial studying?
A study testing active management of the third stage of labor and expectant management of the third stage of labor in people with Childbirth, run by Göteborg University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: blood loss measured up to two hours post partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.