New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia (CONTRADYS)
Primary Purpose
Shoulder Dystocia,, Brachial Plexus Injury, Asphyxia,
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
suctioning of fetal nose and mouth during delivery
Pushing maneuver
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder Dystocia, focused on measuring shoulder dystocia,, Mac Roberts' maneuver,, pushing maneuver
Eligibility Criteria
Inclusion Criteria:
- women having completed 37 or more gestational weeks with singleton vertex fetus, delivering vaginally
Exclusion Criteria:
- patients with caesarean section are excluded
Sites / Locations
- Hôpital Beaujon
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
group M
group C
Arm Description
Normal delivery without "pushing" maneuver suctioning of fetal nose and mouth during delivery
"Pushing" maneuver on the fetal head
Outcomes
Primary Outcome Measures
occurrence of shoulder dystocia
shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).
Secondary Outcome Measures
complications
neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.
Full Information
NCT ID
NCT01297439
First Posted
February 9, 2011
Last Updated
April 29, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01297439
Brief Title
New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia
Acronym
CONTRADYS
Official Title
CONTRADYS : A Randomized Controlled Trial of a New Prophylactic Maneuver, the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
the study stopped due to the lack of inclusion.
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shoulder dystocia is a major obstetric emergency defined as a delivery requiring maneuver in addition to downward traction on the fetal head for delivery of the shoulders. Shoulder dystocia is a major obstetrical complication, occurring in approximately 0.2 to 3% of deliveries, principally due to fetal macrosomia. The obstetrical and neonatal complications associated with shoulder dystocia include newborn mortality occurring in 21 to 290 per 1000 deliveries, generalized asphyxia, fractures, neurological damages (brachial plexus injury) and hematoma. The objective of this study was to evaluate the "pushing" maneuver, that is performed gently on the fetal head since the crowning of the head (appearance of the fetal scalp at the introitus between pushes), aiming to facilitate the anterior shoulder to slip off behind the symphysis pubis, reducing thus the risk of shoulder dystocia. This preventive maneuver may reduce the power (energy/time unit) exerted on the perineal tissues and give the shoulders time to enter the pelvic cavity. The "pushing" maneuver will be evaluated in comparison with either an expectative attitude or a suctioning of fetal nose and mouth.
Detailed Description
Hypothesis: the "pushing" maneuver reduces of 50% the risk of shoulder dystocia in comparison with either an expectative attitude or a suctioning of fetal nose and mouth.
Main objective: to assess whether prophylactic use of the "pushing on the fetal head" maneuver decreases the prevalence of shoulder dystocia, in comparison with an expectative attitude or a suctioning of fetal nose and mouth.
Secondary objective: to compare the occurrence of neonatal complications including brachial plexus injury, clavicle and humerus fracture, hematoma and generalized asphyxia.
Main criterion: occurrence of shoulder dystocia, defined by a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).
Secondary criterion: neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.
Methods: prospective, randomized, multicenter blind study with a modified intention-to-treat analysis. Patients are included during the last obstetrical consultation and randomized in the delivery room.
Number of patients (α error, β error): a sample size of 1126 patients was calculated to allow detection of a 50% reduction of shoulder dystocia, with a prevalence of dystocia reaching 4.3% in usual deliveries (expectative attitude or suctioning of fetal nose and mouth), with a 65% dystocia risk decrease in the group C (α error of 0.05, β error of 0.20).
Inclusion and exclusion criteria. Inclusion: women having completed 37 or more gestational weeks with singleton vertex fetus, delivering vaginally. Exclusion: patients with caesarean section are excluded.
Place of the study: department of gynecology and obstetrics, BEAUJON hospital, Clichy, France and department of gynecology and obstetrics, BICHAT hospital, Paris, France.
Duration of inclusion: two years and 6 months Duration of patients' participation: two months maximum Duration of the study: two years and 9 months. Mean number of inclusion each month: 30 Number of investigation centre: 2 (BEAUJON hospital, BICHAT hospital).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dystocia,, Brachial Plexus Injury, Asphyxia,, Hematoma,, Clavicle Fracture,, Humerus Fracture.
Keywords
shoulder dystocia,, Mac Roberts' maneuver,, pushing maneuver
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1538 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group M
Arm Type
Other
Arm Description
Normal delivery without "pushing" maneuver suctioning of fetal nose and mouth during delivery
Arm Title
group C
Arm Type
Experimental
Arm Description
"Pushing" maneuver on the fetal head
Intervention Type
Procedure
Intervention Name(s)
suctioning of fetal nose and mouth during delivery
Other Intervention Name(s)
M:Mouchage meaning suctioning of fetal nose and mouth
Intervention Description
Normal delivery without "pushing" maneuver: either an expectative attitude or a suctioning of fetal nose and mouth during delivery, since the crowning of the head (appearance of the fetal scalp at the introitus between pushes).
Intervention Type
Procedure
Intervention Name(s)
Pushing maneuver
Other Intervention Name(s)
C ;"contre pulsion" in French, meaning "Pushing maneuver"
Intervention Description
The "pushing" maneuver is performed gently on the fetal head since the crowning of the head (appearance of the fetal scalp at the introitus between pushes), during one uterine contraction, aiming to facilitate the anterior shoulder to slip off behind the symphysis pubis, reducing thus the risk of shoulder dystocia.
Primary Outcome Measure Information:
Title
occurrence of shoulder dystocia
Description
shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).
Time Frame
during delivery
Secondary Outcome Measure Information:
Title
complications
Description
neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.
Time Frame
5 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women having completed 37 or more gestational weeks with singleton vertex fetus, delivering vaginally
Exclusion Criteria:
patients with caesarean section are excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Poujade, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
12. IPD Sharing Statement
Learn more about this trial
New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia
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