Prevention of Post-partum Haemorrhage (TRACOR)

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Haemorrhage; Immediate Postpartum Hemorrhage
• Intervention / Treatment: Procedure: controlled cord traction; Procedure: Clinical signs of placental separation

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 Type: Interventional
• Enrollment (Actual): 4382
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Maternité de Port-Royal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria :

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

Exclusion criteria :

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: controlled cord traction; Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.	Procedure: controlled cord traction; In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs
Active Comparator: clinical signs of placental separation; 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; Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL	immediately to two hours after delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Postpartum embolization or surgery for haemorrhage	Time after delivery
Peripartum haemoglobin delta	Time after delivery
Peripartum haematocrit delta	Time after delivery
Duration of third stage of labour	time before delivery
Deliveries with manual removal of placenta	30 minutes
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour	Time after delivery
Woman's satisfaction	two days after delivery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Catherine Deneux, MD, PhD, Assistance Publique Hopitaux de Paris

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimated): January 7, 2010

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Prevention; Third stage of labour; Postpartum haemorrhage; Controlled cord traction
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Hemorrhage; Puerperal Disorders; Uterine Hemorrhage; Pathological Conditions, Signs and Symptoms; Postpartum Hemorrhage
• Other Study ID Numbers: P081206; AOM09161 (Other Grant/Funding Number: AOM09161)