Effectively conducting operative vaginal delivery and preventing maternal or neonatal injuries in term ( = 37 weeks) mothers. Pregnancy and Childbirth
Conditions
Interventions
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
Sponsors
Mother Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
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. 9.1.3.2. Vaginal Birth After Cesarean Delivery (VBAC) 9.2. Fetal Indications 9.2.1. Fetal Distress in second stage as determined by non-reassuring fetal heart rate pattern or Grade 3 meconium passage 9.2.2. Prolapsed umbilical cord 9.2.3. Premature separation of placenta.
Exclusion criteria
Exclusion criteria: 1. Participant refused to participate in trial/ no informed consent provided 2. Patients with bleeding diathesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactManu Pradeep
Outcome results
None listed