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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01665027
Other study ID # SSU-389049
Secondary ID
Status Completed
Phase Phase 3
First received August 1, 2012
Last updated August 14, 2012
Start date December 2010
Est. completion date January 2012

Study information

Verified date August 2012
Source Shahid Sadoughi University of Medical Sciences and Health Services
Contact n/a
Is FDA regulated No
Health authority Iran: shahid sadoughi university of medical sciences and health services.Yazd, Iran
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date January 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 45 Years
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
routine manual maneuvers for fetal head extraction
fetal head techniques like fundal pushing, pulling technique or reverse breech extraction

Locations

Country Name City State
Iran, Islamic Republic of Shahid sadoughi University of medical sciences Yazd

Sponsors (1)

Lead Sponsor Collaborator
Behnam Baghianimoghadam

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other maternal complications 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). during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions) Yes
Primary 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 Yes
Secondary fetal complications 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). after extraction of fetus and during cleaning of fetus under warmer Yes
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