Comparing outcomes of vaginal delivery with Paily Forceps against a vacuum device
- Conditions
- Effectively conducting operative vaginal delivery and preventing maternal or neonatal injuries in term ( = 37 weeks) mothers.Pregnancy and Childbirth
- Registration Number
- ISRCTN13034177
- Lead Sponsor
- Mother Hospital
- Brief Summary
2022 Results article in https://doi.org/10.1016/j.ejogrb.2022.10.028 (added 07/11/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 100
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.
1. Participant refused to participate in trial/ no informed consent provided
2. Patients with bleeding diathesis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method