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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier:
NCT01665027
First received: August 1, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Complications; Cesarean Section
Procedure: vacuum
Procedure: routine manual maneuvers for fetal head extraction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Sadoughi University of Medical Sciences and Health Services:

Primary Outcome Measures:
  • Mean duration time between incision and fetal head delivery [ Time Frame: during surgery ] [ Designated as safety issue: Yes ]
    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:
  • fetal complications [ Time Frame: after extraction of fetus and during cleaning of fetus under warmer ] [ Designated as safety issue: Yes ]
    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).


Other Outcome Measures:
  • maternal complications [ Time Frame: during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions) ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 108
Study Start Date: December 2010
Study Completion Date: January 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.

Experimental: routine manual maneuvers for fetal head extraction

Procedure/Surgery:

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

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

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665027

Locations
Iran, Islamic Republic of
Shahid sadoughi University of medical sciences
Yazd, Iran, Islamic Republic of, 8916863411
Sponsors and Collaborators
Behnam Baghianimoghadam
  More Information

No publications provided

Responsible Party: Behnam Baghianimoghadam, shahid sadoughi university of medical sciences and health services, Yazd, Iran, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier: NCT01665027     History of Changes
Other Study ID Numbers: SSU-389049
Study First Received: August 1, 2012
Last Updated: August 14, 2012
Health Authority: Iran: shahid sadoughi university of medical sciences and health services.Yazd, Iran

Keywords provided by Shahid Sadoughi University of Medical Sciences and Health Services:
caesarean section,
vacuum,
fetal head extraction,
maternal complication,
fetal complication

ClinicalTrials.gov processed this record on July 23, 2014