Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4382 participants
INTERVENTIONAL
2010-01-31
2012-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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controlled cord traction
Controlled cord traction will be applied as soon as a firm uterine contraction is obtained, and until placental delivery occurs.
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Expected vaginal delivery
* Gestational age ≥ 35 weeks
* Singleton pregnancy
Exclusion Criteria
* Planned caesarean delivery
* Severe hemorrhagic disease
* Multiple Pregnancy
* Placenta praevia
* Intra uterine fetal death
* No health insurance coverage
18 Years
FEMALE
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Catherine Deneux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Maternité de Port-Royal
Paris, , France
Countries
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References
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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.
Other Identifiers
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AOM09161
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P081206
Identifier Type: -
Identifier Source: org_study_id