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Prevention of Post-partum Haemorrhage

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01044082
Acronym
TRACOR
Enrollment
4382
Registered
2010-01-07
Start date
2010-01-01
Completion date
2012-03-01
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immediate Postpartum Hemorrhage, Postpartum Haemorrhage

Keywords

Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention

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.

Interventions

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

PROCEDUREClinical 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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mLimmediately to two hours after delivery

Secondary

MeasureTime frame
Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mLimmediately to two hours after delivery
Measured postpartum blood loss at 30 minutes after deliveryat 30 minutes after delivery
Total measured postpartum blood lossTime after delivery
Curative postpartum uterotonic treatmentTime after delivery
Postpartum transfusionTime after delivery
Postpartum embolization or surgery for haemorrhageTime after delivery
Peripartum haemoglobin deltaTime after delivery
Peripartum haematocrit deltaTime after delivery
Duration of third stage of labourtime before delivery
Deliveries with manual removal of placenta30 minutes
Potential adverse events: uterine inversion, cord rupture, pain during third stage of labourTime after delivery
Woman's satisfactiontwo days after delivery

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCatherine Deneux, MD, PhD

Assistance Publique Hopitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026