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

Phase 3
Completed
Conditions
Complications; Cesarean Section
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

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
Primary Outcome Measures
NameTimeMethod
Mean duration time between incision and fetal head deliveryduring 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
NameTimeMethod
fetal complicationsafter 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

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

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