Postpartum Haemorrhage Clinical Trial
— TRACOROfficial title:
Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage
Verified date | March 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4382 |
Est. completion date | March 2012 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Maternité de Port-Royal | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL | immediately to two hours after delivery | Yes | |
Secondary | Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL | immediately to two hours after delivery | Yes | |
Secondary | Measured postpartum blood loss at 30 minutes after delivery | at 30 minutes after delivery | Yes | |
Secondary | Total measured postpartum blood loss | Time after delivery | Yes | |
Secondary | Curative postpartum uterotonic treatment | Time after delivery | Yes | |
Secondary | Postpartum transfusion | Time after delivery | Yes | |
Secondary | Postpartum embolization or surgery for haemorrhage | Time after delivery | Yes | |
Secondary | Peripartum haemoglobin delta | Time after delivery | Yes | |
Secondary | Peripartum haematocrit delta | Time after delivery | Yes | |
Secondary | Duration of third stage of labour | time before delivery | Yes | |
Secondary | Deliveries with manual removal of placenta | 30 minutes | Yes | |
Secondary | Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour | Time after delivery | Yes | |
Secondary | Woman's satisfaction | two days after delivery | Yes |
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