The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss. A Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Raed Salim
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- Hemoglobin level after delivery
Overview
Brief Summary
Throughout the history, the neonate was dependent on maternal touch and care for survival. In modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome.
Oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.
The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding.
During the typical CD, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period.
Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin secretion increases with ESTS and during breastfeeding.
The aim of this study is to examine blood loss that occurs after Natural CD compared to standard CD without an ESTS contact.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Estimated to be appropriate for gestational age fetus.
- •Sonographic dating before 20 weeks of gestation.
Exclusion Criteria
- •Non-scheduled CD.
- •Major fetal malformations.
- •Multiple gestations.
- •Non-controlled diabetes.
- •Severe pre-eclampsia.
- •General anesthesia.
- •HIV carrier
- •Neonatal need for early resuscitation.
Outcomes
Primary Outcomes
Hemoglobin level after delivery
Time Frame: 4 days
Difference between pre- and post-surgical hemoglobin levels.
Secondary Outcomes
- Pain score during the operation(1 hour)
- Neonatal temperature after delivery(1 hour)
- Breast engorgement(4 days)
- Analgesia use during the operation(1 hour)
- Blood product transfusion(4 days)
- Pain score during the first day after cesarean delivery(24 hours)
- Rate of breastfeeding at maternal hospital discharge(4 days)
- Rate of breastfeeding 6 months after delivery(6 months)
- Maternal satisfaction of the delivery(4 days)
- Analgesia use during the first day after cesarean delivery(24 hours)
Investigators
Raed Salim
Head of delivery unit
HaEmek Medical Center, Israel