Clinical trial NCT01044082: Prevention of Post-partum Haemorrhage
Official title: Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Haemorrhage
Immediate Postpartum Hemorrhage
Keywords: Postpartum haemorrhage
Third stage of labour
Controlled cord traction
Randomized controlled trial
Prevention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-01-07
Enrollment: 4382
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL
timeFrame: immediately to two hours after delivery
Secondary outcomes:
measure: Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL
timeFrame: immediately to two hours after delivery
measure: Measured postpartum blood loss at 30 minutes after delivery
timeFrame: at 30 minutes after delivery
measure: Total measured postpartum blood loss
timeFrame: Time after delivery
measure: Curative postpartum uterotonic treatment
timeFrame: Time after delivery
measure: Postpartum transfusion
timeFrame: Time after delivery
measure: Postpartum embolization or surgery for haemorrhage
timeFrame: Time after delivery
measure: Peripartum haemoglobin delta
timeFrame: Time after delivery
measure: Peripartum haematocrit delta
timeFrame: Time after delivery
measure: Duration of third stage of labour
timeFrame: time before delivery
measure: Deliveries with manual removal of placenta
timeFrame: 30 minutes
measure: Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour
timeFrame: Time after delivery
measure: Woman's satisfaction
timeFrame: two days after delivery
Other outcomes:
Locations:
city: Paris
country: France
facility: Maternité de Port-Royal
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine Deneux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.