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

NCT01297439 | Terminated

• 1 other identifier: P091109
• Study Type: interventional
• Target: 1,538
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dystocia,; Brachial Plexus Injury; Asphyxia,; Hematoma,; Clavicle Fracture,; Humerus Fracture.

Keywords

shoulder dystocia,; Mac Roberts' maneuver,; pushing maneuver

Outcome Measures

Primary Outcomes (1)

• occurrence of shoulder dystocia

  shoulder dystocia is defined as a necessity of requiring a specific obstetrical maneuver (McRoberts' maneuver).

  during delivery

Secondary Outcomes (1)

• complications

  5 days after delivery

Study Arms (2)

group M

OTHER

Normal delivery without "pushing" maneuver suctioning of fetal nose and mouth during delivery

Procedure: suctioning of fetal nose and mouth during delivery

group C

EXPERIMENTAL

"Pushing" maneuver on the fetal head

Procedure: Pushing maneuver

Interventions

suctioning of fetal nose and mouth during delivery PROCEDURE

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).

Also known as: M:Mouchage meaning suctioning of fetal nose and mouth

group M

Pushing maneuver PROCEDURE

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.

Also known as: C ;"contre pulsion" in French, meaning "Pushing maneuver"

group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• patients with caesarean section are excluded

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Beaujon

Clichy, 92110, France

Location

MeSH Terms

Conditions

Shoulder Dystocia; Asphyxia; Hematoma; Humeral Fractures

Condition Hierarchy (Ancestors)

Dystocia; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Hemorrhage; Arm Injuries; Fractures, Bone

Study Officials

• Olivier Poujade, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 16, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

FR (1)