Prevention of Post-partum Haemorrhage

Not Applicable

Completed

• Conditions: Postpartum Haemorrhage; Immediate Postpartum Hemorrhage

• Registration Number: NCT01044082
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2011-01
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4382

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of postpartum haemorrhage, defined as a measured postpartum blood loss greater than 500 mL	immediately to two hours after delivery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maternité de Port-Royal; 🇫🇷 Paris, France