NCT01044082

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,382

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

January 6, 2010

Last Update Submit

February 11, 2026

Conditions

Postpartum HaemorrhageImmediate Postpartum Hemorrhage

Keywords

Postpartum haemorrhageThird stage of labourControlled cord tractionRandomized controlled trialPrevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL

    immediately to two hours after delivery

Secondary Outcomes (12)

  • Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL

    immediately to two hours after delivery

  • Measured postpartum blood loss at 30 minutes after delivery

    at 30 minutes after delivery

  • Total measured postpartum blood loss

    Time after delivery

  • Curative postpartum uterotonic treatment

    Time after delivery

  • Postpartum transfusion

    Time after delivery

  • +7 more secondary outcomes

Study Arms (2)

controlled cord traction

EXPERIMENTAL

Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.

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

Procedure: Clinical signs of placental separation

Interventions

controlled cord tractionPROCEDURE

In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs

controlled cord traction
Clinical signs of placental separationPROCEDURE

Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure

clinical signs of placental separation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Expected vaginal delivery
  • Gestational age ≥ 35 weeks
  • Singleton pregnancy

You may not qualify if:

  • Age \<18
  • Planned caesarean delivery
  • Severe hemorrhagic disease
  • Multiple Pregnancy
  • Placenta praevia
  • Intra uterine fetal death
  • No health insurance coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternité de Port-Royal

Paris, 75014, France

Location

Related Publications (1)

  • 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.

    PMID: 23538918RESULT

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Deneux, MD, PhD

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2011

Study Completion

March 1, 2012

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

FR(1)