New Prophylactic Maneuver: the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia (CONTRADYS)

CONTRADYS : A Randomized Controlled Trial of a New Prophylactic Maneuver, the "Pushing" Maneuver, Aiming to Reduce the Risk for Shoulder Dystocia

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.

Study Overview

• Status: Terminated
• Conditions: Shoulder Dystocia,; Brachial Plexus Injury; Asphyxia,; Hematoma,; Clavicle Fracture,; Humerus Fracture.
• Intervention / Treatment: Procedure: suctioning of fetal nose and mouth during delivery; Procedure: Pushing maneuver

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).

• Study Type: Interventional
• Enrollment (Actual): 1538
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clichy, France, 92110
    • Hopital Beaujon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women having completed 37 or more gestational weeks with singleton vertex fetus, delivering vaginally

Exclusion Criteria:

• patients with caesarean section are excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group M; 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 Names: 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 Names: C ;"contre pulsion" in French, meaning "Pushing maneuver"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occurrence of shoulder dystocia	shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).	during delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	neonatal complications including neurological damages (brachial plexus injury), generalized asphyxia, hematoma, clavicle and humerus fractures.	5 days after delivery

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Olivier Poujade, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 16, 2011

Study Record Updates

• Last Update Posted (Estimate): April 30, 2015
• Last Update Submitted That Met QC Criteria: April 29, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: shoulder dystocia,; Mac Roberts' maneuver,; pushing maneuver
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hemorrhage; Pregnancy Complications; Obstetric Labor Complications; Death; Arm Injuries; Fractures, Bone; Dystocia; Asphyxia; Hematoma; Shoulder Dystocia; Humeral Fractures
• Other Study ID Numbers: P091109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No