Prevention of Post-partum Haemorrhage

Overview

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.

Full Title of Study: “Impact of Controlled Cord Traction During the Third Stage of Labour on the Incidence of Post Partum Haemorrhage”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2011

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.

Interventions

  • 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
  • Procedure: 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

Arms, Groups and Cohorts

  • Experimental: controlled cord traction
    • Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine Deneux, MD, PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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