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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


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
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