Comparing outcomes of vaginal delivery with Paily Forceps against a vacuum device

INTERVENTION: This randomised clinical trial is conducted in the Department of Obstetrics and Gynecology, Mother Hospital, Thrissur, from August 2006 to November 2007, over 16 months. Mother hospital has an annual delivery rate of around 2000. The instrumental delivery rate is about 6‐7%. Informed consent is obtained from all patients admitted to the obstetric unit for elective or emergency operative vaginal delivery. This operative vaginal delivery trial featured two parallel arms interventions: ‐ i) Paily Obstetric Forceps (POF) and ii) Ventouse extractor. Index cards, marked with the choice of intervention, were randomised using a computer‐generated random sequence. They were then placed in envelopes by an independent researcher and stored in opaque boxes in the labour room of the obstetric unit. When the operator decides to intervene during vaginal delivery, an assistant is asked to pick the next envelope from the storage box, which decides the choice of intervention. The patient is not informed about the choice of instrument, prior to intervention. To apply an instrument, the patient is placed in the dorsal lithotomy position. Under aseptic precautions, the bladder is catheterised and emptied. The operator then re‐assesses the patient. On abdominal examination, no pole of head should be palpable. On vaginal examination, based on the position of the presenting part and pelvic dimensions, the cephalo‐pelvic disproportion is ruled out. Then the perineum is cleansed and draped. Perineal block/Local anaesthesia is achieved by infiltrating an appropriate dose of Inj. Xylocaine 1%. The POF (Manufactured by Babu Surgicals, Palakkad, Kerala, India) is a modified obstetric forceps, with shorter (140 mm), CONDITION: Effectively conducting operative vaginal delivery and preventing maternal or neonatal injuries in term ( = 37 weeks) mothers. ; Pregnancy and Childbirth PRIMARY OUTCOME: Success rate of instrumental delivery ‐ calculated by the ratio of deliveries not requiring a second‐line intervention (another instrument or subsequent caesarean delivery) to the total number of instrumental delivery SECONDARY OUTCOME: ; All safety analyses will be conducted on an “As‐treated” basis.; ; 1. Incidence of Maternal adverse events:; 1.1. During the second and third stages of labour:; 1.1.1. Episiotomy extension; 1.1.2. Cervix laceration; 1.1.3. Vaginal laceration; 1.1.4. Perineal laceration; 1.1.5. Paraurethral laceration; 1.1.6. Third and Fourth‐degree perineal lacerations; 1.1.7. Post‐partum haemorrhage (>500 ml of blood loss); 1.2. Fourth stage and puerperium; 1.2.1. Need for blood transfusion; 1.2.2. Urinary retention; 1.2.3. Urinary tract infection; 1.2.4. Episiotomy hematoma; 1.2.5. Anemia; 1.2.6. Need for antibiotics; 1.2.7. Duration of hospitalization; 2. Neonatal outcomes and adverse events:; 2.1. APGAR score at 1st and 5th minute; 2.2. Liquor (Clear/ Grade‐1/Grade‐2/Grade‐3); 2.3. Caput succedaneum; 2.4. Scalp, facial bruising or injuries; 2.5. Cephalhematoma; 2.6. Sub‐galeal hematoma; 2.7. Neonatal jaundice; 2.8. Cerebral edema; 2.9. Sub‐conjunctival hemorrhage; 2.10. 6th and 7th brachial plexus injury; 2.11. Clavicle fracture; 2.12. Intraventricular hemorrhage; 2.13. Neonatal Intensive care unit stay; 2.14. Hospital stay; 2.15. Neonatal death; INCLUSION CRITERIA: 1. Pregnant women above 18 years of age. 2. Term pregnancy (=37 completed weeks of gestational age) 3. Cephalic presentation 4. Fully dilated and fully effaced cervix 5. Ruptured membranes 6. Fetal head at +2 station or lower (Low or Outlet station) 7. Fetal head rotation =45° 8. Clinically adequate pelvis 9. Clinically indicated instrumental delivery: 9.1. Maternal indications: 9.1.1. Prolonged second stage of labor 9.1.2. Maternal exhaustion 9.1.3. Elective application to shorten second stage of labor 9.1.3.1. Medical diseases like cardiac diseases (NYHA Grade 3 or 4), severe pre‐eclampsia, hypertensive crises, cerebrovascular malformation, myasthenia gravis, and spinal cord injury.