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Completed

NCT Number: NCT01044082

Prevention 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled cord traction

Procedure

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 separation

Procedure

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

Primary outcomes

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

    Time frame: immediately to two hours after delivery

Secondary outcomes

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

    Time frame: immediately to two hours after delivery

  2. Measured postpartum blood loss at 30 minutes after delivery

    Time frame: at 30 minutes after delivery

  3. Total measured postpartum blood loss

    Time frame: Time after delivery

  4. Curative postpartum uterotonic treatment

    Time frame: Time after delivery

  5. Postpartum transfusion

    Time frame: Time after delivery

  6. Postpartum embolization or surgery for haemorrhage

    Time frame: Time after delivery

  7. Peripartum haemoglobin delta

    Time frame: Time after delivery

  8. Peripartum haematocrit delta

    Time frame: Time after delivery

  9. Duration of third stage of labour

    Time frame: time before delivery

  10. Deliveries with manual removal of placenta

    Time frame: 30 minutes

  11. Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour

    Time frame: Time after delivery

  12. Woman's satisfaction

    Time frame: two days after delivery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage

Acronym: TRACOR

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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