Postpartum HaemorrhageTRACORNCT01044082
Prevention of Post-partum Haemorrhage
A study testing Clinical signs of placental separation in people with Postpartum Haemorrhage and Immediate Postpartum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Haemorrhage, Immediate Postpartum Hemorrhage
- What is being tested?
- Clinical signs of placental separation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,382 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Mar 2012
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Expected vaginal delivery
- Gestational age ≥ 35 weeks
- Singleton pregnancy
Who cannot join
- Age <18
- Planned caesarean delivery
- Severe hemorrhagic disease
- Multiple Pregnancy
- Placenta praevia
- Intra uterine fetal death
- No health insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage
The primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving prophylactic oxytocin for the management of the third stage of labour.
The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates early postpartum uterine contraction and local haemostasis and decreases post partum blood loss.
Read the detailed description
In this randomized controlled trial, conducted in 6 maternity units, information will be provided to eligible women during a prenatal visit in late pregnancy. Once in labour ward, during labour and before delivery, and if eligible and willing to participate, the woman will be randomly allocated to the intervention or reference group.
In all women, immediately after the birth of the baby, 5 IU prophylactic oxytocin will be intravenously administered, the umbilical cord will be early clamped and cut, and a collector bag placed under the woman's buttocks.
In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
In the reference group, clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure.
All other aspects of the management of the third stage will be standardized and common to all women.
On day 2 postpartum, a venous blood sample will be collected to measure plasma haemoglobin and haematocrit. On the same day, a questionnaire will be filled in by the woman to assess her satisfaction.
- Being tested
- controlled cord traction, Clinical signs of placental separation
- Keywords
- Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
controlled cord tractionProcedure or surgery
In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs
Clinical signs of placental separationProcedure or surgery
Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure
| Study group | Role | What they receive |
|---|---|---|
| controlled cord traction | Experimental | Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs. Receives: Procedure: controlled cord traction |
| clinical signs of placental separation | Active comparator | Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure Receives: Procedure: Clinical signs of placental separation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL
Measured: immediately to two hours after delivery
Secondary outcomes (12)
Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL
Measured: immediately to two hours after delivery
Measured postpartum blood loss at 30 minutes after delivery
Measured: at 30 minutes after delivery
Total measured postpartum blood loss
Measured: Time after delivery
Curative postpartum uterotonic treatment
Measured: Time after delivery
Postpartum transfusion
Measured: Time after delivery
Postpartum embolization or surgery for haemorrhage
Measured: Time after delivery
Peripartum haemoglobin delta
Measured: Time after delivery
Peripartum haematocrit delta
Measured: Time after delivery
Duration of third stage of labour
Measured: time before delivery
Deliveries with manual removal of placenta
Measured: 30 minutes
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour
Measured: Time after delivery
Woman's satisfaction
Measured: two days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum HaemorrhageStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 4,382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Catherine Deneux, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044082
- Sponsor's protocol ID
- P081206
- Other IDs
- AOM09161
- Acronym
- TRACOR
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2010
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deneux-Tharaux C, Sentilhes L, Maillard F, Closset E, Vardon D, Lepercq J, Goffinet F. Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR). BMJ. 2013 Mar 28;346:f1541. doi: 10.1136/bmj.f1541.
PubMed 23538918
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage
- ClinicalTrials.gov ID
- NCT01044082
- Acronym / sponsor ID
- TRACOR / P081206
- Keywords
- Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,382 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Jan 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 primary purpose of the trial is to evaluate whether the management of placental delivery with controlled cord traction (CCT) reduces the incidence of postpartum haemorrhage, compared with management waiting for clinical signs of spontaneous placental separation, in women with vaginal delivery receiving prophylactic oxytocin for the management of the third stage of labour.
The hypothesis is that CCT, by reducing the length of the third stage of labour, facilitates early postpartum uterine contraction and local haemostasis and decreases post partum blood loss.
Detailed description
In this randomized controlled trial, conducted in 6 maternity units, information will be provided to eligible women during a prenatal visit in late pregnancy. Once in labour ward, during labour and before delivery, and if eligible and willing to participate, the woman will be randomly allocated to the intervention or reference group.
In all women, immediately after the birth of the baby, 5 IU prophylactic oxytocin will be intravenously administered, the umbilical cord will be early clamped and cut, and a collector bag placed under the woman's buttocks.
In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
In the reference group, clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure.
All other aspects of the management of the third stage will be standardized and common to all women.
On day 2 postpartum, a venous blood sample will be collected to measure plasma haemoglobin and haematocrit. On the same day, a questionnaire will be filled in by the woman to assess her satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled cord traction | Experimental | Procedure: controlled cord tractionControlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs. |
| clinical signs of placental separation | Active comparator | Procedure: Clinical signs of placental separationClinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Expected vaginal delivery
- Gestational age ≥ 35 weeks
- Singleton pregnancy
Key exclusion criteria (7 listed)
- Age <18
- Planned caesarean delivery
- Severe hemorrhagic disease
- Multiple Pregnancy
- Placenta praevia
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 |
|---|---|---|
| controlled cord tractionIn the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs | Procedure or surgery | controlled cord traction |
| Clinical signs of placental separationClinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure | Procedure or surgery | clinical signs of placental separation |
Primary outcome
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL
Time frame: immediately to two hours after delivery
12 secondary outcomes
Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL
Time frame: immediately to two hours after delivery
Measured postpartum blood loss at 30 minutes after delivery
Time frame: at 30 minutes after delivery
Total measured postpartum blood loss
Time frame: Time after delivery
Curative postpartum uterotonic treatment
Time frame: Time after delivery
Postpartum transfusion
Time frame: Time after delivery
Postpartum embolization or surgery for haemorrhage
Time frame: Time after delivery
Peripartum haemoglobin delta
Time frame: Time after delivery
Peripartum haematocrit delta
Time frame: Time after delivery
Duration of third stage of labour
Time frame: time before delivery
Deliveries with manual removal of placenta
Time frame: 30 minutes
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour
Time frame: Time after delivery
Woman's satisfaction
Time frame: two days 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 13 Feb 2026.
- Results publication: PubMed 23538918Deneux-Tharaux C, Sentilhes L, Maillard F, Closset E, Vardon D, Lepercq J, Goffinet F. Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR). BMJ. 2013 Mar 28;346:f1541. doi: 10.1136/bmj.f1541.
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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.
Catherine Deneux, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical signs of placental separation in people with Postpartum Haemorrhage and Immediate Postpartum Hemorrhage, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 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 13 Feb 2026. 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 France. 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 haemorrhage, defined as a measured postpartum blood loss greater than 500 mL (time frame: immediately to two hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01044082, which also lists 1 linked publication.
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 13 Feb 2026.