New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia (CONTRADYS)
|Shoulder Dystocia, Brachial Plexus Injury Asphyxia, Hematoma, Clavicle Fracture, Humerus Fracture.||Procedure: suctioning of fetal nose and mouth during delivery Procedure: Pushing maneuver|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
|Official Title:||CONTRADYS : A Randomized Controlled Trial of a New Prophylactic Maneuver, the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia|
- occurrence of shoulder dystocia [ Time Frame: during delivery ]shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).
- complications [ Time Frame: 5 days after delivery ]neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.
|Study Start Date:||March 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Normal delivery without "pushing" maneuver suctioning of fetal nose and mouth during delivery
Procedure: suctioning of fetal nose and mouth during delivery
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).
Other Name: M:Mouchage meaning suctioning of fetal nose and mouth
Experimental: group C
"Pushing" maneuver on the fetal head
Procedure: Pushing maneuver
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.
Other Name: C ;"contre pulsion" in French, meaning "Pushing maneuver"
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297439
|Clichy, France, 92110|
|Principal Investigator:||Olivier Poujade, MD||Assistance Publique - Hôpitaux de Paris|