NCT01665027

Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Behnam Baghianimoghadam · Academic / Other
• Sex: Female
• Age: 15 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.

Conditions

• Complications; Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	vacuum	Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16). Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections.
PROCEDURE	routine manual maneuvers for fetal head extraction	fetal head techniques like fundal pushing, pulling technique or reverse breech extraction

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-08-01
• Completion: 2012-01-01
• First posted: 2012-08-15
• Last updated: 2012-08-15

Locations

1 site across 1 country: Iran