Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
1 other identifier
interventional
108
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2010
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 15, 2012
CompletedAugust 15, 2012
August 1, 2012
8 months
August 1, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean duration time between incision and fetal head delivery
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).
during surgery
Secondary Outcomes (1)
fetal complications
after extraction of fetus and during cleaning of fetus under warmer
Other Outcomes (1)
maternal complications
during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions)
Study Arms (2)
vacuum
EXPERIMENTALVacuum 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
EXPERIMENTALProcedure/Surgery: fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
Interventions
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.
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
Eligibility Criteria
You may qualify if:
- term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.
You may not qualify if:
- Elective cesarean
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shahid sadoughi University of medical sciences
Yazd, Yazd Province, 8916863411, Iran
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- shahid sadoughi university of medical sciences and health services, Yazd, Iran
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 15, 2012
Study Start
December 1, 2010
Primary Completion
August 1, 2011
Study Completion
January 1, 2012
Last Updated
August 15, 2012
Record last verified: 2012-08