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

Phase 3

Completed

• Conditions: Complications; Cesarean Section
• Interventions: Procedure: vacuum; Procedure: routine manual maneuvers for fetal head extraction

• Registration Number: NCT01665027
• Lead Sponsor: Behnam Baghianimoghadam

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-08
• Study Completion: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vacuum	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. 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).
routine manual maneuvers for fetal head extraction	routine manual maneuvers for fetal head extraction	Procedure/Surgery: fetal head techniques like fundal pushing, pulling technique or reverse breech extraction

Primary Outcome Measures

Name	Time	Method
Mean duration time between incision and fetal head delivery	during surgery	In study was done by Arad et al in 1986, duration between incision and end of delivery was significantly lower in vacuum group that (PMID: 3735047). Also in study of Dimitrov et al was done prospectively on 19 caesarean with vacuum and 25 caesarean without it, similar results has been reported (PMID: 18756824).

Secondary Outcome Measures

Name	Time	Method
fetal complications	after extraction of fetus and during cleaning of fetus under warmer	Mcquinery et al in 2009 in their study concluded that vacuum have less fetal complications (Mc Quivey RW, Laporte V. Vacuum- Assisted Cesarean Section. International Journal of OB/GYN. 2009; S413-S729.). Wen et al in their study concluded that forceps causes more injuries to head and face while cephal hematoma was higher in using vacuum(PMID: 11159152).

Trial Locations

Locations (1)

Shahid sadoughi University of medical sciences; 🇮🇷 Yazd, Iran, Islamic Republic of