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

Behnam Baghianimoghadam

Status and phase: Completed; Phase 3

Conditions: Complications; Cesarean Section

Treatments: Procedure: routine manual maneuvers for fetal head extraction; Procedure: vacuum

Study type: Interventional

Funder types: Other

Identifiers

NCT01665027

SSU-389049

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.

Exclusion criteria

• Elective cesarean

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

vacuum

Experimental group

Description:

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. 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).

Treatment:

Procedure: vacuum

routine manual maneuvers for fetal head extraction

Experimental group

Description:

Procedure/Surgery: fetal head techniques like fundal pushing, pulling technique or reverse breech extraction

Treatment:

Procedure: routine manual maneuvers for fetal head extraction