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Prevention of Post-partum Haemorrhage (TRACOR)

Primary Purpose

Postpartum Haemorrhage, Immediate Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
controlled cord traction
Clinical signs of placental separation
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Haemorrhage focused on measuring Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maternité de Port-Royal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

controlled cord traction

clinical signs of placental separation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL
Measured postpartum blood loss at 30 minutes after delivery
Total measured postpartum blood loss
Curative postpartum uterotonic treatment
Postpartum transfusion
Postpartum embolization or surgery for haemorrhage
Peripartum haemoglobin delta
Peripartum haematocrit delta
Duration of third stage of labour
Deliveries with manual removal of placenta
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour
Woman's satisfaction

Full Information

First Posted
January 6, 2010
Last Updated
July 25, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01044082
Brief Title
Prevention of Post-partum Haemorrhage
Acronym
TRACOR
Official Title
Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage, Immediate Postpartum Hemorrhage
Keywords
Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4382 (Actual)

8. Arms, Groups, and Interventions

Arm Title
controlled cord traction
Arm Type
Experimental
Arm Description
Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
Arm Title
clinical signs of placental separation
Arm Type
Active Comparator
Arm Description
Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure
Intervention Type
Procedure
Intervention Name(s)
controlled cord traction
Intervention Description
In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs
Intervention Type
Procedure
Intervention Name(s)
Clinical signs of placental separation
Intervention Description
Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure
Primary Outcome Measure Information:
Title
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL
Time Frame
immediately to two hours after delivery
Secondary Outcome Measure Information:
Title
Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL
Time Frame
immediately to two hours after delivery
Title
Measured postpartum blood loss at 30 minutes after delivery
Time Frame
at 30 minutes after delivery
Title
Total measured postpartum blood loss
Time Frame
Time after delivery
Title
Curative postpartum uterotonic treatment
Time Frame
Time after delivery
Title
Postpartum transfusion
Time Frame
Time after delivery
Title
Postpartum embolization or surgery for haemorrhage
Time Frame
Time after delivery
Title
Peripartum haemoglobin delta
Time Frame
Time after delivery
Title
Peripartum haematocrit delta
Time Frame
Time after delivery
Title
Duration of third stage of labour
Time Frame
time before delivery
Title
Deliveries with manual removal of placenta
Time Frame
30 minutes
Title
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour
Time Frame
Time after delivery
Title
Woman's satisfaction
Time Frame
two days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Deneux, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternité de Port-Royal
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23538918
Citation
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. Erratum In: BMJ. 2013;346:f2542. BMJ.2013;347:f6619.
Results Reference
derived

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Prevention of Post-partum Haemorrhage

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