Postpartum HemorrhageNCT00473707
Active Versus Expectant Management of the Third Stage of Labor
A study testing Active management of the third stage of labor, Expectant management of the third stage of labor and Oxytocin and gentle cord traction with fundal massage in people with Postpartum Hemorrhage, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Active management of the third stage of labor, Expectant management of the third stage of labor and Oxytocin and gentle cord traction with fundal massage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jul 2006
- 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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Singleton gestation
- Cephalic presentation
- >37 weeks gestation
- >16 years of age
Who cannot join
- Multiple gestation
- Breech presentation
- Blood dyscrasias
- Multiparous females Para >5
- Placenta previa
- Patients on anticoagulants
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- Previous history of postpartum hemorrhage
- IUFD
- Non-reassuring fetal heart rate pattern
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19718
About this study
Official title: A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor
The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.
Read the detailed description
Postpartum hemorrhage is the leading cause of maternal mortality worldwide. During the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. Controversy remains as to the optimal method of delivering the placenta. Two predominant, yet very different, strategies have emerged. Expectant management is most commonly used in the United States. This includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. Then uterotonic agents are administered,usually oxytocin. This is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. This is the predominant practice in the United Kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine.
Comparison: Active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Active management of the third stage of labor, Expectant management of the third stage of labor, Oxytocin and gentle cord traction with fundal massage, Oxytocin
- Keywords
- Third stage of labor
- 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
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
Expectant management of the third stage of laborProcedure or surgery
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
Oxytocin and gentle cord traction with fundal massageDrug
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage
OxytocinDrug
standardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Active management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage Receives: Procedure: Active management of the third stage of labor; Drug: Oxytocin and gentle cord traction with fundal massage |
| 2 | Other | Expectant management of the third stage of labor Receives: Procedure: Expectant management of the third stage of labor; Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater
Measured: reported immediately after delivery
Secondary outcomes (4)
Mean change in hematocrit from before delivery to the first postpartum day
Measured: 24 hours
Rate of maternal blood transfusion
Measured: 48 hours
Duration of the third stage of labor
Measured: 60 minutes
Incidence of retained placenta
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2007 (estimated)
- Study startAug 2002
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Investigators
- Danielle E Castagnola, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00473707
- Sponsor's protocol ID
- 26008
- Status last verified
- Apr 2023
- First submitted
- 14 May 2007
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Active Versus Expectant Management of the Third Stage of Labor
- ClinicalTrials.gov ID
- NCT00473707
- Acronym / sponsor ID
- 26008
- Conditions
- Postpartum Hemorrhage
- Keywords
- Third stage of labor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Aug 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 May 2007 (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 of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.
Detailed description
Postpartum hemorrhage is the leading cause of maternal mortality worldwide. During the third stage of labor, the period following the delivery of the baby until the delivery of the placenta, the patient is at increased risk for blood loss. Controversy remains as to the optimal method of delivering the placenta. Two predominant, yet very different, strategies have emerged. Expectant management is most commonly used in the United States. This includes waiting for signs of placental separation, followed by maternal pushing to expel the placenta. Then uterotonic agents are administered,usually oxytocin. This is in contrast to active management, which consists of uterotonic administration immediately following delivery of the fetus, in association with gentle umbilical cord traction and fundal massage. This is the predominant practice in the United Kingdom, where the uterotonic agents of choice are either oxytocin alone, or a combination of oxytocin and ergometrine.
Comparison: Active management with oxytocin to expectant management of the third stage of labor on the effect of postpartum hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Active management of the third stage of labor, Drug: Oxytocin and gentle cord traction with fundal massageActive management of the third stage of labor- oxytocin infusion after delivery of fetus, gentle cord traction, and fundal massage |
| 2 | Other | Procedure: Expectant management of the third stage of labor, Drug: OxytocinExpectant management of the third stage of labor |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton gestation
- Cephalic presentation
- >37 weeks gestation
- >16 years of age
Key exclusion criteria (9 listed)
- Multiple gestation
- Breech presentation
- Blood dyscrasias
- Multiparous females Para >5
- Placenta previa
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 laborstandardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage | Procedure or surgery | 1 |
| Expectant management of the third stage of laborstandardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun | Procedure or surgery | 2 |
| Oxytocin and gentle cord traction with fundal massagestandardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) immediately following delivery of the fetus with gentle cord traction and fundal massage | Drug | 1 |
| Oxytocinstandardized oxytocin infusion (10 units of oxytocin in 500 mL of Ringers lactate over 20 minutes) in combination with maternal expulsion efforts once spontaneous separation of the placenta had begun | Drug | 2 |
Primary outcome
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater
Time frame: reported immediately after delivery
4 secondary outcomes
Mean change in hematocrit from before delivery to the first postpartum day
Time frame: 24 hours
Rate of maternal blood transfusion
Time frame: 48 hours
Duration of the third stage of labor
Time frame: 60 minutes
Incidence of retained placenta
Time frame: 30 minutes
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 12 Apr 2023.
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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.
Danielle E Castagnola, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active management of the third stage of labor, Expectant management of the third stage of labor and Oxytocin and gentle cord traction with fundal massage in people with Postpartum Hemorrhage, run by Christiana Care Health Services at 1 site in United States.
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 9 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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Incidence of postpartum hemorrhage, defined as estimated blood loss (EBL) 500mL or greater (time frame: reported immediately after delivery). 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 12 Apr 2023.