Prevention of Post-partum Haemorrhage

Postpartum Haemorrhage Clinical Trial

— TRACOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044082
• Other study ID #: P081206
• Secondary ID: AOM09161
• Status: Completed
• Phase: N/A
• First received: January 6, 2010
• Last updated: July 25, 2012
• Start date: January 2010
• Est. completion date: March 2012

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Immediate Postpartum Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

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

Locations

Country	Name	City	State
France	Maternité de Port-Royal	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

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