Effectiveness And Safety Of Ventouse Extraction Versus Manual Extraction Of Fetal Head At Cesarean Section – A Randomized Controlled Trial In Belgaum, Karnataka, India

Abstract

Objective: To find out the effectiveness and safety of ventouse extraction of fetal head at cesarean section when compared to manual conventional extraction. Study design: A randomized controlled trial. Place: A teaching hospital: J N Medical College, Belgaum. Intervention: Use of Ventouse extractor for the delivery of fetal head at cesarean section in study group. Sample size: 150 (75 in each arm). Outcome measures: Effectiveness - percentage of successful extractions (number of deliveries conducted by the assigned method). Maternal: Estimated blood loss (by estimating hemoglobin level prior to and 48 hours ± 12 hours of cesarean section using HemoCue machine), uterine incision extension. Neonatal: Apgar score, hyperbilirubinemia (occurring within 48 hours of delivery requiring intervention), scalp or head injury. Results: As per the CONSORT flow diagram, 201 women were consented to participate in the study of which eligible 150 were randomized into 2 groups by SNOSE method. The outcome for analysis was available for 73 women (1 on table refusal and 1 had precipitate labor) in conventional manual group and 75 women in ventouse delivery group. Successful extraction was done in 91.78% (67 out of 73) of babies in conventional extraction group compared to 94.67% (71 out of 75) babies in ventouse extraction group (p=0.484). 16 out of 73 women in conventional group had fall in hemoglobin of more than 20% compared to 7 out of 75 women (p<0.034). The uterine incision was significantly higher in conventional group, 12 of the 73 women (16.4%), whereas only 2 of the 75 women in ventouse group had uterine extensions (p<0.04). Significantly higher number of babies had Apgar score of > 7 in ventouse group (82.67%) compared to conventional group (63.01%) at 1 minute. However no difference occurred in apgar score at 5 minute was observed. Hyper bilirubinemia was seen in 10.67% babies in ventouse group compared to 32.88% of babies in conventional extraction group which was statistically significant (p=0.001) as there were significantly more number of low birth weight babies (<2500gms) in conventional group. Conclusion: We conclude that the routine use of ventouse is effective and safe for fetal head extraction at cesarean section.