Prevention of Post-partum Haemorrhage

Study Overview
=================
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.

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

Conditions
-----------------
Postpartum Haemorrhage, Immediate Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Procedure: controlled cord traction
* Procedure: Clinical signs of placental separation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: controlled cord traction<br>Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs. | Procedure: controlled cord traction<br>* In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs<br>|
| Active Comparator: clinical signs of placental separation<br>Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure | Procedure: Clinical signs of placental separation<br>* Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL |  | immediately to two hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe postpartum haemorrhage, defined as a measured postpartum blood loss greater than 1000mL |  | immediately to two hours after delivery | 
| Measured postpartum blood loss at 30 minutes after delivery |  | at 30 minutes after delivery | 
| Total measured postpartum blood loss |  | Time after delivery | 
| Curative postpartum uterotonic treatment |  | Time after delivery | 
| Postpartum transfusion |  | Time after delivery | 
| Postpartum embolization or surgery for haemorrhage |  | Time after delivery | 
| Peripartum haemoglobin delta |  | Time after delivery | 
| Peripartum haematocrit delta |  | Time after delivery | 
| Duration of third stage of labour |  | time before delivery | 
| Deliveries with manual removal of placenta |  | 30 minutes | 
| Potential adverse events: uterine inversion, cord rupture, pain during third stage of labour |  | Time after delivery | 
| Woman's satisfaction |  | two days after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postpartum haemorrhage, Third stage of labour, Controlled cord traction, Randomized controlled trial, Prevention