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| ID | Type | Description | Link |
|---|---|---|---|
| AOM09161 | Other Grant/Funding Number | AOM09161 |
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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlled cord traction | Experimental | Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs. |
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| clinical signs of placental separation | Active Comparator | Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| controlled cord traction | Procedure | In the intervention group, controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs |
| 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 |
| 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 |
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Inclusion criteria :
Exclusion criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Deneux, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternité de Port-Royal | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23538918 | Result | Deneux-Tharaux C, Sentilhes L, Maillard F, Closset E, Vardon D, Lepercq J, Goffinet F. Effect of routine controlled cord traction as part of the active management of the third stage of labour on postpartum haemorrhage: multicentre randomised controlled trial (TRACOR). BMJ. 2013 Mar 28;346:f1541. doi: 10.1136/bmj.f1541. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Clinical signs of placental separation | Procedure | Clinical signs of placental separation will be awaited for, and then placental expulsion may be helped through maternal pushing and/or hypogastric pressure |
|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |