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Prevention of Post-partum Haemorrhage (TRACOR)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01044082
First received: January 6, 2010
Last updated: July 25, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Postpartum Haemorrhage
Immediate Postpartum Hemorrhage
 Procedure: controlled cord traction
Procedure: Clinical signs of placental separation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL [ Time Frame: immediately to two hours after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL [ Time Frame: immediately to two hours after delivery ] [ Designated as safety issue: Yes ]
  • Measured postpartum blood loss at 30 minutes after delivery [ Time Frame: at 30 minutes after delivery ] [ Designated as safety issue: Yes ]
  • Total measured postpartum blood loss [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Curative postpartum uterotonic treatment [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Postpartum transfusion [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Postpartum embolization or surgery for haemorrhage [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Peripartum haemoglobin delta [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Peripartum haematocrit delta [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Duration of third stage of labour [ Time Frame: time before delivery ] [ Designated as safety issue: Yes ]
  • Deliveries with manual removal of placenta [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
  • Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour [ Time Frame: Time after delivery ] [ Designated as safety issue: Yes ]
  • Woman's satisfaction [ Time Frame: two days after delivery ] [ Designated as safety issue: Yes ]

Enrollment: 4382
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: controlled cord traction
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044082

Locations
France
Maternité de Port-Royal
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Catherine Deneux, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01044082     History of Changes
Other Study ID Numbers: P081206, AOM09161
Study First Received: January 6, 2010
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postpartum haemorrhage
Third stage of labour
Controlled cord traction
Randomized controlled trial
Prevention

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
 Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on June 17, 2013