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

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ClinicalTrials.gov Identifier: NCT01665027
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services

August 1, 2012
August 15, 2012
August 15, 2012
December 2010
August 2011   (Final data collection date for primary outcome measure)
Mean duration time between incision and fetal head delivery [ Time Frame: 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).
Same as current
No Changes Posted
fetal complications [ Time Frame: 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).
Same as current
maternal complications [ Time Frame: during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions) ]
In wei study maternal complication like spreading of uterine incision and cervical rupture was lower in control group (PMID: 11159152). Pelosi et al also concluded that vacuum can lower maternal complications (PMID: 6716375). Mcquinvey et al in 2009 in their study found six patients with spreading incision and 1 case of cervical rupture in routine cesarean section but there was no case of these complications in vacuum group. Of course Bofill et al did not find any different between their groups in this context (PMID: 11110345).
Same as current
 
Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
Not Provided
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Complications; Cesarean Section
  • 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
  • Experimental: 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).
    Intervention: Procedure: vacuum
  • Experimental: routine manual maneuvers for fetal head extraction

    Procedure/Surgery:

    fetal head techniques like fundal pushing, pulling technique or reverse breech extraction

    Intervention: Procedure: routine manual maneuvers for fetal head extraction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
Same as current
January 2012
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
15 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01665027
SSU-389049
Not Provided
Not Provided
Not Provided
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
Behnam Baghianimoghadam
Not Provided
Not Provided
Shahid Sadoughi University of Medical Sciences and Health Services
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP