Prevention of Post-partum Haemorrhage (TRACOR)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Immediate Postpartum Hemorrhage; Postpartum Haemorrhage

Treatments: Procedure: controlled cord traction; Procedure: Clinical signs of placental separation

Study type: Interventional

Funder types: Other

Identifiers

NCT01044082

P081206

AOM09161 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,382 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,382 participants in 2 patient groups

controlled cord traction

Experimental group

Description:

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

Treatment:

Procedure: controlled cord traction

clinical signs of placental separation

Active Comparator group

Description:

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

Treatment:

Procedure: Clinical signs of placental separation