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Completed

NCT Number: NCT01665027

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

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.

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Key information

Conditions

Complications; Cesarean Section

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shahid sadoughi University of medical sciences

Yazd, Yazd Province, 8916863411, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vacuum

Procedure

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

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Behnam Baghianimoghadam

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Aug 15, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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